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1. Introduction
Type 1 diabetes is a complex metabolic disease that involves multiple organ systems which can cause severe visual impairment. Almost all ocular structures may be afflicted in diabetes including: the extraocular muscles, the intraocular lens, the optic nerve, and the retina.
Diabetes is the leading cause of blindness between the ages of 20 and 74 in many developed countries. Individuals with diabetes are 25 times more likely to become legally blind than individuals without diabetes. The aspect of diabetic eye disease most responsible for vision loss is diabetic retinopathy, which accounts for ¼ of blind registrations in the Western world [1,2]. There are two main pathways by which diabetic retinopathy affects vision; fluid accumulation in the center of vision, or macular edema, and the formation of pathological retinal vessels also known as proliferative diabetic retinopathy.
Prevention of severe visual impairment in type 1 diabetes includes: optimal glycemic control, the treatment of ancillary risk factors such as hypertension, and regular screening for early diagnosis and treatment of ocular complications.
In the following chapter, we will describe how diabetes affects different ocular structures and discuss the treatment options available today to combat these complications.
2. Extraocular muscles
Patients with diabetes may present with a sudden onset of diplopia (double vision). This is usually caused by a paresis of one of the extraocular muscles due to microvascular damage to the third, fourth, or the sixth cranial nerves [3,4].
When the extraocular muscle deficit is due to microvascular complications of diabetes the prognosis is good. Recovery of ocular motor function generally begins within three months of onset and recovery is usually complete. Although the diplopia can be debilitating, due to the generally limited course of these complaints, patients can usually be effectively managed conservatively with eye patching. When diplopia is from large divergence of the visual axes, patching one eye is the only practical short-term solution. When the deviation is smaller, the diplopia often can be resolved by using glasses with a horizontal or vertical prism or both. Surgery is rarely indicated.
If patients do not recover from a cranial nerve palsy within 6-12 months, eye muscle surgery to treat persistent and stable angle diplopia should be considered. These patients should consult with a neuro-ophthalmologist for continuing care.
3. Intraocular lens: Cataract
Cataract is a common cause of visual impairment in patients with diabetes. The Framingham study [5] revealed a three- to four fold increased prevalence of cataract in diabetic patients under the age of 65, and up to a twofold increased prevalence in patients above 65. Duration of diabetes and quality of glycemic control are the major risk factors for early cataract development [5].
Recurrent high levels of glucose in the lens lead to the glycolation of lens proteins from increased nonenzymatic glycation and oxidative stress to the lens [6]. This causes diabetic patients to develop age-related lens changes similar to nondiabetic age-related cataracts, except that they tend to occur at a younger age [7]. Several studies have analyzed the effect of vitamin and antioxidant supplements, such as vitamin C, E, and beta carotene and zinc, on preventing or slowing progression of age-related cataracts in diabetes without showing any statistically significant benefit with their use [6].
Early cataracts may cause mild visual impairment that can be managed reasonably with spectacle correction. Cataract surgery is indicated when visual function is significantly impaired by the cataract or if the cataract obscures the view of the retina and makes the diagnosis and treatment of diabetic retinopathy difficult.
Cataract surgery is safe in diabetic patients and there is a 95% success rate in terms of improved visual acuity [6]. Good glycemic control, fluid and electrolyte balance should be maintained perioperatively and the patient’s treating physician and anesthesiologist should be involved in the process. It is recommended that the surgery be scheduled in the morning to minimize changes in the patient’s usual schedule [8].
Some controversy exists regarding a potential association between cataract surgery and a subsequent worsening of diabetic retinopathy. Patients should be made aware of this risk preoperatively. Cataract surgery and its effect on diabetic retinopathy will be discussed in more detail in section 7.3.2.
4. Cornea
Corneal disorders secondary to diabetes (diabetic keratopathy) are increasingly recognized as a cause of ocular morbidity associated with diabetes. Patients with diabetes have structural changes of the corneal basement membrane that contributes to defects in the adhesion of corneal epithelial cells to the deeper stromal tissue [9]. This increases the risk of recurrent corneal erosions. In addition, accumulation of sorbitol in the cornea during periods of hyperglycemia leads to hypoesthesia (a loss of corneal sensation). Both hypoesthesia and epithelial adhesion dysfunction occur more frequently with increased severity and duration of diabetes. In patients with more long-standing or advanced diabetes, any corneal epithelial injury, either from trauma, during ocular surgery or from routine contact lens use, may result in prolonged healing times. This increases the risk of severe complications such as bacterial infiltration and ulceration.
Treatment of diabetic keratopathy is multifaceted, including artificial tears for mild cases, and the use of topical antibiotics, a bandage contact lens, eye patching, or closure for more severe cases.
5. Iris
Rubeosis iridis, neovascularization of the iris, is a serious complication of diabetes which occurs in patients with severe diabetic retinopathy [3]. Severe retinal ischemia stimulates the formation of numerous intertwining blood vessels on the anterior surface of the iris. These vessels can block aqueous outflow from the anterior chamber, leading to a sharp and persistent rise in intraocular pressure. This complication is known as neovascular glaucoma. This type of glaucoma is hard to treat and is often associated with pain from very high ocular pressure. Topical medical therapy used commonly in other forms of glaucoma is less effective. Treatment should include aggressive control of the underlying diabetic retinopathy. The treatment of diabetic retinopathy will be discussed in more detail in section 7.
6. Retina – Diabetic retinopathy
Damage to the retinal capillaries, known as diabetic retinopathy, is the hallmark of diabetic eye disease. This condition is the major cause of blindness and visual disability in patients with type 1 diabetes.
There are two main pathways by which diabetic retinopathy can reduce vision: macular edema and proliferative retinopathy. These conditions can appear concomitantly or separately with the treatment protocol tailored to the relative severity each condition.
Macular edema develops when damaged retina vessels leak fluid and protein. These deposits collect on or under the macula of the eye where central vision is processed. This causes the macula to thicken and swell and may distort central vision.
Proliferative retinopathy occurs when diffuse injury to retinal vessels severely impairs retinal oxygenation. The hypoxia induces the release of proteins which stimulate the growth (or proliferation) of new, fragile retinal vessels. These new vessels have a propensity to bleed, which severely reduces vision.
In the following sections, we will discuss how retinopathy and macular edema develop and the various treatment options available to patients today, with a focus on exciting recent developments.
6.1. Epidemiology
Diabetic retinopathy is one of the most frequent causes of preventable blindness in working aged adults (20-74 years) [1,10]. In the USA, an estimated 86% of patients with type 1 diabetes have some degree of diabetic retinopathy. Data from the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR) showed that within 5 years of diagnosis of type 1 diabetes, 14% of patients developed retinopathy, with the incidence rising to 74% by 10 years [11,12]. In people with retinopathy at the WESDR baseline examination, 64% had their retinopathy worsen, 17% progressed to proliferative diabetic retinopathy (PDR), and about 20% developed diabetic macular edema during 10 years of follow-up.
The WESDR data in type 1 diabetics showed that 25 years after diagnosis, 97% of patients developed retinopathy, 43% progressed to PDR, 29% developed diabetic macular edema, and 3.6% of patients younger than 30 at diagnosis were legally blind [11]. The WESDR results also showed a reduction in the yearly incidence and progression of diabetic retinopathy during the past 15 years [12]. This may be signaling an improved ocular prognosis for diabetics today, possibly due to recent advances in glycemic control, ophthalmic treatment, and patient education.
The course of diabetic retinal disease in children with type 1 diabetes is fairly benign. Severe vision-reducing complications are uncommon in children before puberty [13].
6.2. Risk factors
There are several risk factors which influence the development and progression of diabetic retinopathy. The following list contains most of the important risk factors known today.
Modifiable risk factors:
Hyperglycemia: Good glycemic control has been shown to significantly prevent the development and progression of diabetic retinopathy. Every 1% decrease in hemoglobin A1C leads to a 40% reduction in the risk of developing retinopathy, a 25% reduction in the risk of progression to vision-threatening retinopathy, and a 15% reduction in the risk of blindness [1,14,15].
Hypertension: Good blood pressure control is important in reducing the risk of retinopathy. Every 10 mmHg reduction in systolic blood pressure leads to a reduction of 35% in the risk of retinopathy progression and a reduction of 50% in the risk of visual loss [1].
Obesity: Obesity (BMI>30 kg/m(2)) is an important risk factor for diabetic retinopathy progression in type 1 diabetes, independent of HbA1c levels [16].
Smoking: There is some evidence that smoking may be a risk factor in progression of retinopathy in type 1 diabetes [17].
Nonmodifiable risk factors:
Diabetes duration: The longer the duration of diabetes, the higher the risk of developing diabetic retinopathy and of having a severe manifestation of this disease [1].
Genetic factors: The Diabetes Control and Complications Trial [18] showed a heritable tendency for developing diabetic retinopathy, regardless of other risk factors. The abnormal development of new blood vessels is regulated by protein called vascular endothelial growth factor A (VEGF –A). Variation in the sequence of this gene is associated with the development of severe diabetic retinopathy [19].
Ethnicity: Diabetic retinopathy in America is more prevalent among African Americans, Hispanic and south Asian groups than in Caucasians with otherwise similar risk profiles [1].
Gender: there is an observed gender dimorphism with younger females being at greater risk for diabetic retinopathy early in the course of diabetes [20] and males demonstrating greater risk later in life [21].
Other risk factors:
Pregnancy: Pregnancy is associated with worsening of diabetic retinopathy [22]. All pregnant women need to be closely monitored throughout pregnancy. Pregnancy in type 1 diabetes is discussed in further detail in section 7.3.1.
6.3. Pathophysiology
Diabetic retinopathy develops when hyperglycemia and other causal risk factors trigger a cascade of biochemical changes which damage retinal blood vessels. Hyperglycemia increases sorbitol levels via the action of aldose reductase increasing oxidative stress by reducing intracellular levels of reduced glutathione, an important antioxidant [23]. Intracellular hyperglycemia also increases synthesis of diacylglycerol, an activating cofactor for protein kinase C (PKC). Activated PKC decreases the production of anti-artherosclerotic factors and increases production of pro-artherogenic factors, pro-adhesive and pro-inflammatory factors [23]. As well, intracellular hyperglycemia leads to a rise in intracellular N-acetylglucosamine levels. This by-product reacts with serine and threonine residues in transcription factors, resulting in pathologic changes in gene expression [23]. The final by-product of these pathological processes is increased inflammation and increased oxidative stress, which causes endothelial cell dysfunction in retinal blood vessels.
Endothelial cell dysfunction induces retinal arteriolar dilatation, which increases capillary bed pressure. This results in microaneurysm formation, vessel leakage, and rupture [1]. Vascular permeability is also increased from loss of pericytes and increased endothelial proliferation in retinal capillaries. The breakdown of the blood–retinal barrier allows fluid to accumulate in the deep retinal layers where it damages photoreceptors and other neural tissues. This is the mechanism by which macular edema reduces visual acuity.
In some capillaries there is endothelial cell apoptosis. Vessels become acellular, leading to vascular occlusion and nonperfusion of local retinal tissue [23]. The resultant retinal ischemia promotes the release of inflammatory growth factors, such as vascular endothelial growth factor, growth-hormone-insulin growth factor, and erythropoietin [1]. These factors influence neovascularization, the growth of new capillaries, which are generally ineffective in improving tissue oxygenation as they often grow up toward the vitreous cavity.
6.4. Clinical features and classification
Diabetic retinopathy is classified as nonproliferative diabetic retinopathy (NPDR) when the vascular changes are limited to the retinal surface. It is classified as proliferative diabetic retinopathy (PDR) in the more advanced stage when new blood vessels form, which grow from the retinal surface up toward the vitreous cavity.
Diabetic macular edema occurs when leaky capillary beds allow fluid to accumulate in the part of the retina responsible for central vision. This complication can occur in patients with any level of underlying retinopathy from mild NPDR to severe PDR. Visual impairment is usually related to the state of macular disease and the consequences of neovascularization such as vitreous hemorrhage and retinal detachment. As such, the level of retinopathy does not always correlate with visual function, and severe diabetic retinopathy can be present initially without significant visual loss.
6.5. Diabetic macular edema
Diabetic macular edema (DME) is the complication of retinopathy responsible for most of the moderate visual loss in retinopathy patients. The loss of vision is often very mild at first, but without effective treatment it can progress and patients can lose the ability to perform activities of daily living such as reading and driving. Diabetic macular edema is assessed separately from the stage of retinopathy (NPDR/PDR) and it can manifest along a different and independent course.
The edema evolves when damage to the macular capillary bed causes increased retinal vascular permeability and fluid accumulation in the macula. Clinical examination can reveal rings of hard exudates (lipid-filled macrophages) that delineate the area of focal leakage.
Optical Coherence Tomography (OCT) is a useful ancillary imaging technique in DME. Recent technological advances in OCT technology have provided physicians with high-resolution images of the retina in cross-sectional slices. Aside from demonstrating areas of retinal thickening and intraretinal fluid, OCT obtains quantitative measurements of central retinal thickness. Serial OCT examinations are often used as a noninvasive and accurate method analyzing treatment response in DME patients [1].
Figure 1.
Normal OCT of the macular region.
Figure 2.
Macular edema: The OCT demonstrates the disruption of the normal macular anatomy due to macular edema.
Figure 3.
Posttreatment OCT: The same patient as in Figure 2 after treatment with intravitreal injections. The edema has been reabsorbed.
In NPDR, the retinal microvascular changes do not extend beyond the surface of the retina. Clinical findings include microaneurysms (saccular enlargements of weakened capillaries), intraretinal hemorrhages, hard exudates (lipid-filled macrophages), cotton wool spots (nerve fiber layer infarcts), venous dilatations, and intraretinal microvascular abnormalities (dilated preexisting capillaries) [1,10].
NPDR is classified as mild, moderate, or severe, reflecting the risk of progression to PDR (Table 1) as determined by the Early Treatment in Diabetic Retinopathy Study [24].
Figure 4.
Nonproliferative diabetic retinopathy: Scattered hemorrhages (“dot and blot” shaped) can be seen throughout the retina.
6.5.2. Proliferative Diabetic Retinopathy (PDR)
Diabetic retinopathy advances to the proliferative stage when new vessels (neovascularizations) are formed which grow up from the retinal surface toward the vitreous cavity. The growth of these vessels is potentiated by the progression of diabetic retinal microvascular disease, causing severe retinal ischemia. This induces the release of proangiogenic factors which promote the growth of these pathological vessels. Neovascularizations can be identified clinically as a jumble of disorganized, fine vessels emanating from the organized retinal vessel architecture. Angiography is also very effective at identifying neovascular lesions as the new vessels are porous and leak fluorescent dye into the vitreous cavity.
The new vessels in PDR evolve in three stages. Initially, the fine new vessels grow with minimal fibrous tissue. Then the new vessels increase in gauge and length with an increased fibrous component. Finally, the vessels regress and the residual fibrovascular tissue along the posterior surface of the vitreous body contracts.
Retinal neovascularizations (NV) are divided into two subtypes based on their relative risk of causing severe visual loss as demonstrated by the Diabetic Retinopathy Study (DRS). Vascular proliferations on or near the optic disc are termed NV-disc (NVD) and proliferations elsewhere are termed NV-elsewhere (NVE). The presence of NVD carries the higher risk of severe visual loss and requires more urgent treatment [25,26].
Figure 5.
Neovascularization on the optic disc (NVD): The growth of fine new blood vessels can be seen on the optic disc. Urgent treatment is indicated to reduce the risk of vitreous hemorrhage.
Figure 6.
Vitreous hemorrhage with a neovascularization of the optic disc (NVD): The fragile blood vessels of the NVD have ruptured and a vitreous hemorrhage has collected, partially obscuring the macula and severely limiting vision.
PDR is graded from early to high risk according to the extent of the neovascular proliferations. The DRS [25,26] defined high-risk PDR as the presence of either: NVD with a vitreous hemorrhage, NVD larger than a quarter disc area without vitreous hemorrhage, or NVE larger than half disc area with vitreous hemorrhage. Without treatment, patients with early PDR have 50% risk of developing high-risk PDR in 1 year and those with high-risk PDR have a 25% risk of severe visual loss within 2 years. Treatment of PDR involving extensive peripheral laser ablation of the retina is discussed section 7.2.3.
The most common complication of PDR is vitreous hemorrhage caused by bleeding from the pathological neovascular vessels. Retinal detachments can also occur from the contraction of the neovascular tissue connecting the retinal surface to the vitreous.
Figure 7.
Traction Retinal Detachment: The neovascular tissue emanating from the optic disc and elsewhere has regressed leaving behind white fibrous tissue. This tissue has contracted and is distorting the retina in the macular region.
Visual acuity in the absence of macular disease is often very good in PDR until a complication occurs; most commonly vitreous hemorrhage. This sudden transition from good vision to near blindness is often traumatic for patients who were unaware of the severity of their diabetic eye disease.
\n\t\t
\n\t\t
\n\t\t
\n\t\t\n\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\tClinical Features\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\tProgression Risk\n\t\t\t\t
\n\t\t\t
\n\t\t\n\t\t
\n\t\t\t
Mild NPDR
\n\t\t\t
Few microaneurysms
\n\t\t\t
5% progress to PDR within 1 year
\n\t\t
\n\t\t
\n\t\t\t
Moderate NPDR
\n\t\t\t
Microaneurysms and other microvascular lesions
\n\t\t\t
12-16% progress to PDR within 1 year
\n\t\t
\n\t\t
\n\t\t\t
Severe NPDR (Meets 1 of 3 criteria)
\n\t\t\t
• Extensive intraretinal hemorrhages and microaneurysms in all four quadrants • Venous beading in two or more quadrants • One IRMA
\n\t\t\t
52% progress to PDR within 1 year 15% progress to high risk PDR within 1 year
\n\t\t
\n\t\t
\n\t\t\t
Very severe NPDR
\n\t\t\t
Any two of the features of severe NPDR
\n\t\t\t
75% progress to PDR within 1 year 45% progress to high risk PDR within 1 year
\n\t\t
\n\t\t
\n\t\t\t
Early PDR
\n\t\t\t
\n\t\t\t
50% risk of developing high risk PDR in 1 year
\n\t\t
\n\t\t
\n\t\t\t
High risk PDR
\n\t\t\t
\n\t\t\t
25% risk of severe visual loss within 2 years
\n\t\t
\n\t
Table 1.
Clinical classification of nonproliferative and proliferative diabetic retinopathy
7. Treatment of diabetic retinopathy
The main goal of treatment of diabetic retinopathy is to prevent complications that can lead to vision loss. Treatment should include both ocular therapy and systemic medical intervention.
7.1. Medical treatment
Hyperglycemia, hypertension, and hyperlipidemia are known risk factors for the development and progression of diabetic retinopathy. Treating and controlling these factors is crucial to preventing and limiting disease progression.
The Diabetes Control and Complications Trial [14] showed that intensive glycemic control reduced both the risk of developing retinopathy and the rate of progression of existing retinopathy. Intensive glycemic control reduced the risk for progression to severe NPDR and PDR, and the incidence of diabetic macular edema. Every percent reduction in hemoglobin A1C lowers the risk of retinopathy development by 30-40%.
Antihypertensive treatment with ACE (angiotensin-converting enzyme) inhibitors can slow progression of diabetic nephropathy. The EUCLID study [27] investigated the effect of Lisinopril on progression of retinopathy in normotensive type 1 diabetics. They found that Lisinopril can decrease retinopathy progression in nonhypertensive patients who have type 1 diabetes with little or no nephropathy, although the mechanism is unclear. Unfortunately, other studies investigating the effect of ACE inhibitors on the progression of DR in type 1 diabetics have shown no significant benefits.
7.2. Ocular therapy
Ocular therapy in diabetic retinopathy includes panretinal or focal laser photocoagulation, intravitreal injections of either steroids or inhibitors of Vascular Endothelial Growth Factor (VEGF), surgery, or a combination of the aforementioned treatments. The suitable treatment regimen must be tailored individually for each patient and is based on clinical status of the patient (ocular and systemic), previous treatments, and data from the several reported and ongoing studies.
7.2.1. Diabetic macular edema treatment
Treatment options for diabetic macular edema (DME) include focal laser photocoagulation, intravitreal injections of either steroids or anti-VEGF compounds, and surgery.
7.2.1.1. Focal laser treatment
Until recently, the mainstay of DME treatment was macular laser photocoagulation. Treatment criteria are based on the ETDRS recommendations [24], which showed that eyes with macular edema involving or adjacent to the central macula, defined as clinically significant macular edema (CSME), benefited from macular laser treatment. Laser treatment reduced the risk of moderate visual loss (loss of three lines of vision) by 50% over 2 years compared with no treatment [24].
Macular laser treatment for CSME involves the application of discrete laser burns to areas of leakage in the macula. The treatment is not painful and can be repeated up to every 4 months.
Side effects of macular laser photocoagulation include: visual field loss, choroidal neovascularization, subretinal fibrosis, and inadvertent foveolar burns [10].
Modified photocoagulation techniques have been developed in response to these potential complications. The target of macular laser treatment for CSME is retinal pigment epithelium (RPE). Ideally, the laser energy would be absorbed only by the RPE and not spread to the surrounding tissues. Unfortunately, in conventional argon laser photocoagulation visible burns are created, indicating damage to the inner neural retina from the spread of thermal energy beyond the RPE.
Subthreshold diode laser micropulse (SDM) therapy delivers short pulses, which cause less thermal damage. Shorter laser exposure times confine the laser energy to a smaller zone, inflicting less damage on the neural retinal and choriocapillaries. SDM laser has been shown to be as effective as a conventional laser with fewer side effects [28].
7.2.1.2. Steroid injections
Inflammatory factors play an important role in the development of diabetic retinopathy. Upregulation of adhesion molecules in blood vessels leads to leukostasis and the accumulation of macrophages in the retinal vessels. These macrophages release angiogenic growth factors [29] and cytokines which increase vascular permeability. Glucocorticoids block the action of these macrophages and downregulate ICAM-1, which mediates leukocyte adhesion and transmigration [30].
In addition, glucocorticoids alter the composition of endothelial basal membrane by changing the local ratio of two laminin isoforms [31], suppressing basement membrane dissolution, and strengthening tight junctions to limit permeability and leakage that cause macular edema [32]. For this reason, it has long been thought that ocular steroid injections may be beneficial in DME treatment.
Intravitreal triamcinolone acetonide
Triamcinolone acetonide (TA) is a synthetic steroid of the glucocorticoid family with a molecular weight of 434.50. In 2001–2002, the first reports were published of the use of intravitreal injection of triamcinolone acetonide for DME [33,34]. The most common dose used is 4 mg.
Sutter et al. [35] reported in a prospective, double-masked, and randomized trial comparing 4 mg intravitreal TA with sham injection (saline). This study reported that 55% of 33 eyes treated with 4 mg of intravitreal TA improved by 5 or more letters of vision at 3 months compared with 16% of 32 eyes treated with sham injection.
The DRCR.net (diabetic retinopathy clinical research network) protocol I [36] studied the use of 4 mg TA combined with macular laser. It found that TA combined with laser significantly improved vision over macular laser alone in patients who had previously undergone cataract surgery. In patients who had not previously undergone cataract surgery TA was much less effective.
Potential side effects of corticosteroid injections include cataract formation and glaucoma. Moreover, as the treatment effect wanes, patients require repeated injections that increase the glaucoma and especially the cataract risk.
Instead of intermittent bolus therapy, it is thought that sustained release of a lower-dose glucocorticoid may lead to greater efficacy with fewer complications. This has led to the development of slow-release steroid implants.
Dexamethasone intravitreal implant
Dexamethasone is a strong synthetic member of the glucocorticoid class of steroid, with an anti-inflammatory and immunosuppressant activity 30 times greater than cortisol and 6 times greater than triamcinolone.
A sustained-release intravitreal dexamethasone (DEX) implant (Ozurdex®, Allergan Inc, Irvine, CA) is biodegradable and is placed in the vitreous cavity using a 22-gauge applicator through a small self-sealing puncture.
Dexmathasone implants have been examined in several large studies; The PLACID study [37] compared a DEX implant (0.7 mg) to treatment with focal laser. This 1-year study did not show a statistically significant visual improvement with the DEX implant.
The MEAD study [38] combined the results of two multicenter 3-year sham-controlled, masked, randomized clinical studies comparing DEX injection to focal laser treatment. Patients receiving the 0.7 DEX implant required mean of 4.1 injections over 3 years. The average visual improvement with the 0.7 mg DEX implant was +6 letters versus +1 letter with focal laser. Rates of cataract-related adverse events in phakic eyes were 67.9% and 20.4% in the DEX implant 0.7 mg, and sham groups, respectively. Two patients (0.6%) in the DEX implant 0.7 mg group required trabeculectomy for severe glaucoma. Based on the MEAD study, the Food and Drug Administration (FDA) approved DEX implants for use in DME.
Fluocinolone acetonide
Fluocinolone acetonide is a corticosteroid with average mass of 452 Da. ILUVIEN is a nonbioerodable intravitreal implant in a drug delivery system containing fluocinolone acetonide. The fluocinolone acetonide (FA) intravitreal implant [39] is administered in the clinic using a 25-gauge inserter designed to release the drug slowly over 36 months. Unlike the DEX implant, it is not bioerodable.
The FAME studies [40] were two phase 3 clinical trials examining the effect of long-acting fluocinolone acetonide inserts in patients with DME. Patients were randomized in a 2:2:1 ratio to the 0.2 µg per day FA implant, the 0.5 µg per day FA implant, or sham injection (saline). The mean improvement in BCVA letter score between baseline and month 24 was 4.4 and 5.4 in the low- and high-dose groups, respectively, compared with 1.7 in the sham group. Cataract extraction was performed 74.9% of all phakic subjects at baseline in the low-dose insert group and 84.5% in the high-dose insert group compared with 23.1% in the sham group.
Severely elevated intraocular pressure requiring glaucoma surgery occurred in 8.1% of patients in the high dose group, 5.8% of patients in the low dose group, compared only 0.5% in the sham treatment group [40].
This FA implant was approved in Europe (Austria, France, Germany, and Portugal) for the treatment of DME unresponsive to all other therapies. However, it was recently denied approval for this use by the US FDA, due to concerns centering on the high risk of severe glaucoma.
Vascular Endothelial Growth Hormone (VEGF) is a subfamily of growth factors produced by hypoxic cells that act as signal proteins to stimulate angiogenesis and vascular permeability. One of the main drivers of diabetic eye disease is damage to retinal blood vessels leading to tissue ischemia [41]. Hypoxic cells are then stimulated to release VEGF. Unsurprisingly, elevated levels of VEGF have been demonstrated in the eyes of patients with diabetic retinopathy [42,43]. Elevated VEGF stimulates both retinal vessel proliferation and increased vascular permeability producing the macular edema seen in diabetic eye disease [44].
The injection of anti-VEGF agents to the vitreous is both effective and safe. Adverse ocular effects with an incidence rate of less than 1% and include: cataract formation, retinal detachment, vitreous hemorrhage, and infection. Potential systemic adverse effects include: hypertension, stroke, and myocardial infarction but these are very uncommon [45]. Although there is a theoretical risk for arterial thromboembolic events in patients receiving VEGF-inhibitors by intravitreal injection, the observed incidence rate has been low in all studies and similar to that seen in patients randomized to placebo [1,46].
Over the past 10 years, anti-VEGF agents have become the first line of therapy in treating DME. There are three commercially available anti-VEGF agents: (i) Ranibizumab, (ii) Bevacizumab, and (iii) Aflibercept.
Ranibizumab
Ranibizumab (Lucentis®; Genentech, South San Francisco, California) is a humanized monoclonal antibody fragment directed at all isoforms of VEGF-A. Ranibizumab contains only the Fab fragment of the parental anti-VEGF antibody with weight of 48 kDa. Several large clinical trials have investigated the role of Ranibizumab in the treatment of diabetic macular edema.
READ-2 [47] was a 6-month multicenter trial where patients were randomized in a 1:1:1 fashion to macular laser; monthly Ranibizumab; or a combination of laser and monthly Ranibizumab. At 6 months, the combination therapy and Ranibizumab-only groups gained 3.80 and 7.2 letters at month 6, respectively, compared with no change in the laser only group.
RESTORE [48] was a similar 12-month phase 3 clinical trial which compared Ranibizumab to both laser alone and to laser combined with Ranibizumab. All patients receiving Ranibizumab received three initial consecutive monthly injections followed by pro re nata (PRN, as needed) injections as determined at the monthly examination. At month 12, both the Ranibizumab alone and Ranibizumab with laser groups improved by 6 letters, while the laser alone group remained nearly unchanged. Patients required a mean of seven Ranibizumab injections and the change in vision was statistically significant.
As the data supporting Ranibizumab supplanting laser for primary treatment of center-involving DME grew, many physicians were unsure of the continuing role of focal laser in DME. To answer this among other questions, the DRCR.net [49,50] performed a randomized trial which notably compared two methods of combining adjuvant laser with Ranibizumab injections. In one arm of the study (prompt laser), focal laser was given to all the patients at initiation and repeated every 4 months as needed. In the other arm (delayed laser), focal laser could only be added if the edema persisted beyond 24 weeks of monthly Ranibizumab treatment. After 3 years of follow-up, the average gain in the prompt laser group was 7 letters compared with 10 letters in the delayed laser group. Based on these results, it is generally accepted that treatment for center-involving DME should begin with an anti-VEGF agent. Focal laser may be added only if the edema is persistent despite several consecutive anti-VEGF injections. The FDA approved Ranibizumab for treatment of DME in 2012.
Bevacizumab
Bevacizumab (Avastin®; Genentech, South San Francisco, California) is a full-length recombinant humanized monoclonal immunoglobulin G1κ antibody weighing 149 kDa which inactivates all VEGF isoforms. It was FDA-approved in 2004 as a treatment for colon cancer. However, as emerging evidence pointed to VEGF as a central player in DME, ophthalmologists began to use bevacizumab as an “off-label” treatment.
One of the criticisms of Bevacizumab use is that it has not been specifically formulated for ocular use. Bevacizumab is sold in large vials intended for intravenous uses and compounding pharmacies aliquot the medication into prefilled syringes for ocular use. Although there have been case reports of contamination due to this extra step in the preparation process, the safety of Bevacizumab for ocular use has been well established in trials for Age-related Macular Degeneration with a side-effect profile similar to Ranibizumab [51].
Bevacizumab has yet to be approved by the FDA for use in DME. Despite this it is used in many jurisdictions because of its efficacy and its significantly lower cost compared with Ranibizumab. One study [52] estimated the cost of treating DME with Ranibizumab was 20-fold higher than treating with Bevacizumab.
BOLT [53], a 2-year trial comparing bevacizumab monotherapy with focal laser, is the best randomized trial supporting the use of Bevacizumab for center-involving DME. Eighty patients with center-involved DME were randomized to receive either every 6-weekly intravitreal bevacizumab injections (1.25 mg) or focal laser monotherapy.
At 2 years, there was a mean gain of 8.6 letters for Bevacizumab alone compared with a mean loss of 0.5 letters in the laser group.
Aflibercept
Aflibercept (EYLEA®-Regeneron Pharmaceuticals, Tarrytown, New York, NY, and Bayer Healthcare Pharmaceuticals, Berlin, Germany) is a 115-kDa anti-VEGF agent. This protein was developed by combining the extracellular binding domains of VEGF receptors1 and 2 to the Fc segment of human immunoglobulin-G1.Similar to Ranibizumab and Bevacizumab, Aflibercept binds to all isomers of the VEGF-A family.
The phase II DA VINCI [54] trial compared two doses of Aflibercept, 0.5 mg and 2.0 mg, to laser treatment. The average improvement in visual acuity at 52 weeks was +11 letters for monthly 0.5 mg, +13 letters for monthly 2.0 mg and −1 letters for laser alone.
A separate arm of this trial received 3 monthly 2 mg doses followed by a scheduled dose every 8 weeks. Patients in this arm received an average of 7.2 injections per year, as compared with over 12 for monthly dosing. The average visual change was +10 letters. Ocular adverse events were consistent with those seen in other trials with anti-VEGF drugs.
The recently completed phase III VIVID [55] and VISTA [56] trials were similarly designed. Both supported the finding that a schedule of 5 monthly doses of Aflibercept followed by regular bimonthly dosing was of similar efficacy to continuous monthly injections.
In 2014, FDA approved EYLEA for the treatment of diabetic macular edema. The recommended dosage is 2 mg every 2 months, after five initial monthly injections.
Method of administration
The injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anaesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection, in accordance with local practice.
The injection needle should be inserted 3.5-4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming toward the center of the globe. The injection volume of 0.05 ml is then delivered.
The use of pre- or postinjection topical antibiotics is not recommended as they have not been shown to alter the infection risk [57].
Visual acuity is not usually affected in nonproliferative diabetic retinopathy unless there is damage to the macula in the form of macular edema or ischemia. Ocular treatment at this stage is definitively indicated only if there is evidence of macular disease.
The goal of treatment in proliferative diabetic retinopathy (PDR) is to prevent complications and lower the risk of severe vision loss. The mainstay of treatment for PDR is laser ablation of the peripheral retina where laser burns are placed over the entire retina, sparing the central macula. This treatment is called panretinal photocoagulation (PRP). PRP promotes the regression and arrest of progression of retinal neovascularizations by destroying ischemic retinal tissue and reducing ischemia-driven VEGF production [1,10].
The Diabetic Retinopathy Study (DRS) [25,26] evaluated efficacy of PRP treatment in eyes with advanced NPDR or PDR (DRS Group, 1981). The DRS study recommended prompt treatment in eyes with high-risk PDR (defined in section 6.4.3), because these eyes had the highest risk for severe visual loss. PRP treatment in these patients reduced the risk of severe visual loss by 50% over 5 years.
The ETDRS study [24,58] found that PRP treatment in eyes with early PDR reduced the risk of progression to high-risk PDR by 50%, and significantly reduced the risk of severe visual loss [24]. Based on these results, PRP treatment should be considered in eyes with any stage PDR especially if there is poor metabolic control, a noncompliant patient, or difficulty in maintaining close follow-up.
Figure 8.
Panretinal photocoagulation: The retinal tissue surrounding the macular region has been ablated using Argon laser. Circular grey-black scars demark areas previously treated with laser burns.
Full PRP treatment as recommended by the DRS [25,26] and the ETDRS [24,58] includes as many as 5000 laser burns. PRP can be painful and is often performed over several sessions. After the initial treatment course, additional therapy can be applied if there is persistent neovascularization. After treatment, proliferative retinal tissue may regress and contract causing a vitreous hemorrhage or a traction retinal detachment from contracture of fibrovascular tissue. Side effects of PRP treatment also include decreased in night vision, decreased color vision, and loss of peripheral vision [10].
When PDR presents with macular edema, PRP treatment may initially increase the amount of edema [58]. In such case, it is recommended to treat the macular edema with an intravitreal injection before initiating PRP [59,60].
7.2.3.1. Surgery in proliferative diabetic retinopathy
Vitrectomy surgery is most commonly performed in PDR for a dense vitreous hemorrhage causing severe vision loss. If an eye which has not previously undergone PRP develops a significant hemorrhage and vision loss, vitrectomy is recommended when the hemorrhage persists beyond 1–3 months. Patients with vitreous hemorrhage that have preexisting complete PRP may undergo a longer observation period as many patients will have a spontaneous improvement beyond the initial 4 weeks [10,61]. Traction retinal detachment induced by the contraction of neovascular tissue connecting the retinal surface to the vitreous is another serious complication of PDR. If central vision is affected surgery is recommended. However, traction detachments which do not involve the central macula can remain stable for years. Surgery is indicated only when the traction retinal detachment involves or threatens the central macula or if a retinal tear develops [10].
Common complications after vitrectomy include corneal epithelial defects, cataract formation, elevated intraocular pressure, recurrent vitreous hemorrhage, iatrogenic retinal breaks, and rhegmatogenous retinal detachment. The development of these complications can be minimized by meticulous surgical technique and cautious postoperative follow-up.
7.2.3.2. Role of anti-VEGF agents
Several studies have evaluated the efficacy of adjunctive intravitreal anti-VEGF injections in patients with PDR [46]. Adding an anti-VEGF agent to eyes undergoing PRP reduces the risk of a vitreous hemorrhage 12 months after PRP [62]. In eyes with PDR and a dense vitreous hemorrhage, a Bevacizumab injection has been shown to aid significantly in clearing the hemorrhage [63]. This allows PRP to be completed and may reduce the number of patients ending up in surgery.
Bevacizumab has also been shown to enhance retinal surgery in patients with PDR. A single Bevacizumab injection given 1 week before vitrectomy for vitreous hemorrhage, results in decreased bleeding during surgery, decreased operating time, and less postoperative vitreous hemorrhage as compared to vitrectomy [46,64]. As separate study found that a preoperative Bevacizumab injection improved visual acuity 12 months postoperatively compared with vitrectomy alone [62].
Figure 9.
Summary of the two main pathways by which diabetic retinopathy can reduce vision.
7.3. Special considerations
7.3.1. Diabetic retinopathy in pregnancy
In women with preexisting diabetes, pregnancy is considered an independent risk factor for the development and progression of diabetic retinopathy [65]. Most of the progression of diabetic retinopathy in pregnancy occurs by the end of the second trimester. Although regression of retinopathy usually occurs postpartum, there is still an increased risk for progression during the first year postpartum [65]. Risk factors for the development and progression of diabetic retinopathy in pregnancy include longer duration of diabetes before conception, rapid normalization of hemoglobin A1C at the beginning of pregnancy, poor glycemic control during pregnancy, diabetic nephropathy, high blood pressure, and preeclampsia [65,66].
Severity of diabetic retinopathy before or at beginning of pregnancy is also a strong predictor of progression of retinopathy during and after pregnancy. The Diabetes in Early Pregnancy Study [67] showed that 10.3% of women without diabetic retinopathy and 18.8% with mild NPDR experienced retinopathy progression during pregnancy, and 6.3% of women with mild NPDR progressed to PDR. In women with moderate NPDR, 54.8% suffered retinopathy progression and 29% developed PDR. Overall, progression to sight-threatening diabetic retinopathy, including macular edema and PDR, occurs in 6% of pregnant diabetic women [66].
Progression of retinopathy during pregnancy is probably related to the hypervolemic and hypercoagulable states in pregnancy, as well as elevated pro-inflammatory and angiogenic factor levels. This results in capillary occlusion and leakage-aggravating diabetic retinopathy mechanisms [65,68]. Ideally, good glycemic control and full treatment of preexisting diabetic retinopathy complications should be attained before conception.
All diabetic women who plan pregnancy should be referred by their treating physician to an ophthalmologist. The recommended follow-up of pregnant women with type 1 diabetes includes an ophthalmologic exam at the beginning of pregnancy and during the first trimester. Subsequent follow-up depends on the stage of diabetic retinopathy found on the initial examinations. In women with no retinopathy or very mild NPDR, an ophthalmologic exam is indicated when there are visual complaints. In moderate NPDR, an exam should be done at least once during the second trimester and every 4–6 weeks during the third trimester. In severe NPDR and PDR, close follow-up is needed, and an exam should be done every 4–6 weeks, from the beginning of the second trimester.
Treatment of diabetic retinopathy during pregnancy includes maximal control of both glucose levels and blood pressure [66]. Ocular therapy such as PRP should definitely be performed for PDR and be strongly considered in cases of severe NPDR. Disease progression can be very fast in pregnancy and waiting for PDR to clearly develop may result in severe complications that necessitate invasive surgery. Ocular therapy for PDR and macular edema during pregnancy can include PRP, focal laser, and intravitreal steroid injections. Although there are not much data on the safety of intravitreal injections of anti-VEGF agents during pregnancy, the literature includes some reports on the safe and effective use of Bevacizumab [69].
7.3.2. Cataract surgery in patients with diabetic retinopathy
Cataract development is major factor compromising vision in diabetic patients. Surgery often results in significant vision improvements but these can be mitigated by the progression of diabetic retinopathy and macular edema.
7.3.2.1. Macular edema progression following cataract extraction
Progression of macular edema following cataract extraction can limit the expected improvement in visual acuity from cataract surgery. The reported rates of macular edema following cataract extraction varies from 4% to 70%, depending upon the method used to identify macular edema (angiographic, biomicroscopic, OCT), the cataract extraction technique, and underlying comorbidities [70,71].
The DRCR.net [72] conducted a multicenter, prospective, observational study including 293 participants with diabetic retinopathy but without significant macular edema requiring treatment. The authors concluded that in eyes with diabetic retinopathy, the presence of noncentral-involved macular edema immediately prior to cataract surgery, or a history of macular edema treatment may increase the risk of developing central-involving macular edema 16 weeks after cataract extraction.
Topical Nonsteroidal Anti-inflammatory Agents
Controlling postsurgical inflammation is an important factor in preventing macular edema development. Prostaglandin release considerably contributes to fluid leakage from perifoveal capillaries into the extracellular space of the macular region. Multiple studies have reported the benefits of using nonsteroidal anti-inflammatory eye drops pre- and postoperatively to reduce the rate of edema progression [73,74].
Antivascular Endothelial Growth Factor Injections
Recent studies have shown a potential benefit using intravitreal anti-VEGF injections at the end of cataract surgery especially in cases with poorly controlled or refractory macular edema before surgery [46,75,76]. High-risk patients who received intravitreal Bevacizumab or Ranibizumab benefit from better outcomes in terms of visual acuity, macular thickness, and retinopathy progression.
7.3.2.2. Diabetic retinopathy progression following cataract extraction
Controversy exists in the ophthalmic community as to whether cataract surgery potentiates diabetic retinopathy progression. Several studies have reported worsening of diabetic retinopathy and macular edema after surgery [77-80]. Progression was seen during the first year after surgery and was highest in the first 3 months postoperatively. A review of several other studies, especially in the era of cataract surgery using the smaller incision phacoemulsification technique, showed no significant progression of diabetic retinopathy and macular edema after surgery [81,82]. Overall, it is likely that uncomplicated phacoemulsification does not result in a substantially increased risk of the DR progression [83]. The observed rates of progression after uncomplicated, small-incision surgery are similar to the natural course of retinopathy progression over time. The vision improvement and the ability to better visualize the retina to monitor retinopathy progression clearly outweigh the current risks of modern-day cataract extraction and subsequent retinopathy progression over time [83], Overall, diabetics with cataracts benefit from surgery, and improved visual acuity is reported in 92–94% of patients [81]. The combined evidence suggests that in patients with low risk or absent diabetic retinopathy, there is no increased risk of retinopathy progression. However, patients with more advanced retinopathy have an increased risk for retinopathy progression and a worse visual acuity outcome.
7.3.2.3. Summary
A thorough evaluation of patients with diabetes is warranted before cataract surgery. Patients who have severe NPDR or PDR should be considered for PRP treatment prior to cataract removal [84]. Patients with significant macular edema should undergo treatment with a steroid or anti-VEGF agent preoperatively. Ideally, surgery should be delayed until stabilization of retinopathy and macular edema is achieved. In refractory cases, adjunctive therapy with a steroid of anti-VEGF agent at the end of cataract surgery should be considered. Close postoperative follow-up with an ophthalmologist is highly recommended in all patients with preexisting diabetic retinopathy.
8. Schedule for ophthalmologic examinations
Regular ocular examination can detect early ocular disease such as cataracts and glaucoma as well as retinopathy. Diabetic retinopathy in type 1 diabetes is rare during the first 5 years after diagnosis, so the baseline ophthalmologic examination could be extended to 5 years after diagnosis. In children with prepubertal diabetes, the baseline examination should be done at puberty [13].
The timing and frequency of follow-up ocular examinations depends on individual patient’s status. In high-risk patients with long-term diabetes and poor systemic risk factor control, annual examinations should be performed even in the absence of retinopathy. In patients with known retinopathy, the examination schedule is based on the degree of retinopathy, and on the patient’s compliance and adherence to regular follow-up. In mild NPDR, an examination should be performed every 9–12 months; in moderate NPDR, every 6 months; and in severe NPDR, PDR and CSME follow-up should be even more frequent even in the absence of ongoing treatment [10].
Diabetes is the leading cause of vision loss in working-age patients, mainly due to diabetic retinopathy. The mainstay in the prevention of disease progression remains optimizing glycemic control and controlling other ancillary risk factors. Laser treatments which prevent vision loss remain an important option for many patients with advanced diabetic retinopathy. Recent advances in medical treatment over the past decade, especially intraocular injections for macular edema, show great promise due to their ability to improve vision. Today, more than ever before, patients with even advanced diabetic eye disease have a good chance of maintaining functional vision for many years provided they undergo proper screening to diagnose complications as they arise. The cost of these new treatments is significant both in financial terms and in terms of patient time investment, as frequent, often monthly, clinic visits are often recommended to optimize results. Additional studies are still needed in order to develop more effective and less costly treatments to further improve the visual prognosis for diabetic patients.
\n',keywords:"Diabetic retinopathy, Macular edema, Laser, Intraocular injection, Cataract",chapterPDFUrl:"https://cdn.intechopen.com/pdfs/49234.pdf",chapterXML:"https://mts.intechopen.com/source/xml/49234.xml",downloadPdfUrl:"/chapter/pdf-download/49234",previewPdfUrl:"/chapter/pdf-preview/49234",totalDownloads:1100,totalViews:364,totalCrossrefCites:1,totalDimensionsCites:0,hasAltmetrics:0,dateSubmitted:"October 18th 2014",dateReviewed:"July 29th 2015",datePrePublished:null,datePublished:"November 14th 2015",dateFinished:null,readingETA:"0",abstract:"Type 1 diabetes can reduce vision by affecting various parts of the eye. Proactive, interdisciplinary coordination of treatment and timely referrals can aid in the minimization of visually threatening complications, significantly enhancing patient quality of life. The main causes of visual impairment in diabetes are proliferative diabetic retinopathy and macular edema. Until recently, the mainstay of treatment for both conditions was retinal laser, which prevented significant vision loss but was much less effective at improving vision, especially in macular edema. Over the past decade, exciting new advances in treating diabetic eye disease, namely intraocular steroid and antivascular endothelial growth factor injections, have greatly improved the visual prognosis for the majority of patients with diabetic eye disease.",reviewType:"peer-reviewed",bibtexUrl:"/chapter/bibtex/49234",risUrl:"/chapter/ris/49234",book:{slug:"major-topics-in-type-1-diabetes"},signatures:"Efraim Berco, Daniel Rappoport, Ayala Pollack, Guy Kleinmann and\nYoel Greenwald",authors:[{id:"58067",title:"Dr.",name:"Yoel",middleName:null,surname:"Greenwald",fullName:"Yoel Greenwald",slug:"yoel-greenwald",email:"yoel_greenwald@hotmail.com",position:null,institution:null}],sections:[{id:"sec_1",title:"1. Introduction",level:"1"},{id:"sec_2",title:"2. Extraocular muscles",level:"1"},{id:"sec_3",title:"3. Intraocular lens: Cataract",level:"1"},{id:"sec_4",title:"4. Cornea",level:"1"},{id:"sec_5",title:"5. Iris",level:"1"},{id:"sec_6",title:"6. Retina – Diabetic retinopathy",level:"1"},{id:"sec_6_2",title:"6.1. Epidemiology",level:"2"},{id:"sec_7_2",title:"6.2. Risk factors",level:"2"},{id:"sec_8_2",title:"6.3. Pathophysiology",level:"2"},{id:"sec_9_2",title:"6.4. Clinical features and classification",level:"2"},{id:"sec_10_2",title:"6.5. Diabetic macular edema",level:"2"},{id:"sec_10_3",title:"6.5.1. Nonproliferative Diabetic Retinopathy (NPDR)",level:"3"},{id:"sec_11_3",title:"6.5.2. Proliferative Diabetic Retinopathy (PDR)",level:"3"},{id:"sec_14",title:"7. Treatment of diabetic retinopathy",level:"1"},{id:"sec_14_2",title:"7.1. Medical treatment",level:"2"},{id:"sec_15_2",title:"7.2. Ocular therapy",level:"2"},{id:"sec_15_3",title:"7.2.1. Diabetic macular edema treatment",level:"3"},{id:"sec_15_4",title:"7.2.1.1. Focal laser treatment",level:"4"},{id:"sec_16_4",title:"7.2.1.2. Steroid injections",level:"4"},{id:"sec_17_4",title:"7.2.1.3. Anti-vascular endothelial growth hormone compounds",level:"4"},{id:"sec_19_3",title:"7.2.2. Nonproliferative diabetic retinopathy treatment",level:"3"},{id:"sec_20_3",title:"7.2.3. Proliferative diabetic retinopathy treatment",level:"3"},{id:"sec_20_4",title:"7.2.3.1. Surgery in proliferative diabetic retinopathy",level:"4"},{id:"sec_21_4",title:"7.2.3.2. Role of anti-VEGF agents",level:"4"},{id:"sec_24_2",title:"7.3. Special considerations",level:"2"},{id:"sec_24_3",title:"7.3.1. Diabetic retinopathy in pregnancy",level:"3"},{id:"sec_25_3",title:"7.3.2. Cataract surgery in patients with diabetic retinopathy",level:"3"},{id:"sec_25_4",title:"7.3.2.1. Macular edema progression following cataract extraction",level:"4"},{id:"sec_26_4",title:"7.3.2.2. Diabetic retinopathy progression following cataract extraction",level:"4"},{id:"sec_27_4",title:"7.3.2.3. Summary",level:"4"},{id:"sec_31",title:"8. Schedule for ophthalmologic examinations",level:"1"},{id:"sec_32",title:"9. Conclusion",level:"1"}],chapterReferences:[{id:"B1",body:'Cheung N, Mitchell P,Wong TY. Diabetic Retinopathy. The Lancet 2010; 376: 124-36. DOI: 10.1016/S0140-6736(09)62124-3.'},{id:"B2",body:'Fauci AS, Brownwald E, Kasper DL et al. (Eds.) McGraw-Hill Powers AC. Diabetes Mellitus. Harrison’s Principles of Internal Medicine. Retrieved from: http://www.accessmedicine.com'},{id:"B3",body:'Thomas D, Graham E. Ocular disorders associated with systemic disease. In: Riordan-Eva P & Whitcher JP (Eds.) Vaughan & Asbury’s General Ophthalmology, McGraw-Hill,2008. Retrieved from: http://www.accessmedicine.com'},{id:"B4",body:'Kline LB, Tariq-Bhatti M, Chung SM et al. (Eds.) Section 5: Neuro-ophthalmology. Basic and Clinical Science Course, -2011,American Academy of Ophthalmology. American Academy of Ophthalmology.'},{id:"B5",body:'Leibowitz HM, Krueger DE, Dawber TR et al. 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A 2-year prospective randomized controlled trial of intravitreal bevacizumab or laser therapy (BOLT) in the management of diabetic macular edema: 24-month data: Report 3. Arch Ophthalmol 2012;130(8):972–979.'},{id:"B54",body:'DA VINCI Study Group. One-year outcomes of the DA VINCI study of VEGF trap-eye in eyes with diabetic macular edema. Ophthalmology 2012;119(8):1658–1665. DOI: 10.1016/j.ophtha.2012.02.010'},{id:"B55",body:'Heier J. Intravitreal aflibercept for diabetic macular edema: 12 month efficacy and safety results of phase 3, randomized, controlled VISTA-DME and VIVID-DME studies. 2014.'},{id:"B56",body:'Diana D. Visual and anatomic outcomes from the VISTA-DME and VIVID-DME studies of intravitreal aflibercept injection in diabetic macular edema patients with and without prior treatment for DME. 2014.'},{id:"B57",body:'Storey P, Dollin M, Garg SJ et al. Post-Injection Endophthalmitis Study Team. The role of topical antibiotic prophylaxis to prevent endophthalmitis after intravitreal injection. Ophthalmology 2014 Jan;121:283-289. DOI: 10.1016/j.ophtha.2013.08.037.'},{id:"B58",body:'ETDRS 1991: Early photocoagulation for diabetic retinopathy. ETDRS Report 9. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology 1991;98(5):766-785.'},{id:"B59",body:'Silva PS, Sun JK, Aiello LP et al. Role of steroids in the management of diabetic macular edema and proliferative diabetic retinopathy. Sem Ophthalmol 2009;24(2):93-99. DOI: 10.1080/08820530902800355.'},{id:"B60",body:'Mirshahi A, Roohipoor R, Lashay A et al. Bevacizumab-augmented retinal laser photocoagulation in proliferative diabetic retinopathy: a randomized double- masked clinical trial. Eur J Ophthalmol 2008;18(2):263-269.'},{id:"B61",body:'El Annan J, Carvounis PE. Current management of vitreous hemorrhage due to proliferative diabetic retinopathy. Int Ophthalmol Clin 2014;54:141-153. 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Pregnancy-induced sight- threatening diabetic retinopathy in women with type 1 diabetes. Diabet Med 2010; 27(4):431-435. DOI: 10.1111/j.1464-5491.2010.02958.x.'},{id:"B67",body:'Chew EY, Mills JL, Metzger BE et al. Metabolic control and progression of retinopathy. The Diabetic in Early Pregnancy Study. National Institute of Child Health and Human Development. Diabetes in Early Pregnancy Study. Diabetes Care1995;18(5):631-637.'},{id:"B68",body:'Kastelan S, Tomic M, Pavan J,Oreskovic S. Maternal immune system adaptation to pregnancy – a potential influence on the course of diabetic retinopathy. Reproduct Biol Endocrinol 2010;8:124-128. DOI: 10.1186/1477-7827-8-124.'},{id:"B69",body:'Tarantola RM, Folk JC, Culver Boldt H, Mahajan VB. Intravitreal Bevacizumab during pregnancy. Retina. 2010; 30(9): 1405-1411. DOI: 10.1097/IAE.0b013e3181f57d58.'},{id:"B70",body:'Kim SJ, Equi R, Bressler NM. Analysis of macular edema after cataract surgery in patients with diabetes using optical coherence tomography. Ophthalmology 2007 May;114:881-889.'},{id:"B71",body:'Ostri C, Lund-Andersen H, La Cour M et al. Phacoemulsification cataract surgery in a large cohort of diabetes patients: visual acuity outcomes and prognostic factors. J Cataract Refract Surg 2011;37:2006-2011. DOI: 10.1016/j.jcrs.2011.05.030.'},{id:"B72",body:'Diabetic Retinopathy Clinical Research Network Authors/Writing Committee, Baker CW, Almukhtar T, Stockdale C et al. Macular edema after cataract surgery in eyes without preoperative central-involved diabetic macular edema. JAMA Ophthalmol 2013;131:870-879. DOI: 10.1001/jamaophthalmol.2013.2313.'},{id:"B73",body:'O\'Brien TP. Emerging guidelines for use of NSAID therapy to optimize cataract surgery patient care. Curr Med Res Opin 2005 Jul;21:1131-1137.'},{id:"B74",body:'Singh R, Alpern L, Sager D et al. Evaluation of nepafenac in prevention of macular edema followingcataract surgery in patients with diabetic retinopathy. Clin Ophthalmol 2012;6:1259-1269. DOI: 10.2147/OPTH.S31902.'},{id:"B75",body:'Cheema RA, Al- Mubarak MM, Amin YM et al. Role of combined cataract surgery and intravitreal Bevacizumab injection in preventing progression of diabetic retinopathy; prospective randomized study. J Cataract Refract Surg 2009;35:18-25. DOI: 10.1016/j.jcrs.2008.09.019'},{id:"B76",body:'Chen CH, Liu YC, Wu PC. The combination of intravitreal Bevacizumab and phacoemulsification surgery in patients with cataract and coexisting diabetic macular edema. J Ocular Pharmacol Therapeut 2009; 25,83-89. DOI: 10.1089/jop.2008.0068.'},{id:"B77",body:'Pollack A, Dotan S, Oliver M. Course of diabetic retinopathy following cataract surgery. Brit J Ophthalmol 1991;75(1):2-8.'},{id:"B78",body:'Hauser D, Katz H, Pokroy R. et al. Occurrence and progression of diabetic retinopathy after phacoemulsification cataract surgery. J Cataract Refract Surg 2004; 30(2): 428-432.'},{id:"B79",body:'Jaffe GJ, Burton TC, Kuhn E. et al. Progression of nonproliferative diabetic retinopathy and visual outcome after extracapsular cataract extraction and intraocular lens implantation. Am J Ophthalmol 1992; 114(4):448-456.'},{id:"B80",body:'Hayashi K, Igrarashi C, Hirata A et al. Changes in diabetic macular edema after phacoemulsification surgery. Eye (London). 2009; 23(2): 386-389.'},{id:"B81",body:'Rashid S, Young LH. Progression of diabetic retinopathy and maculopathy afterphacoemulsification surgery. Int Ophthalmol Clin/ 2010; 50(1): 155-166. doi: 10.1097/IIO.0b013e3181c555cf.'},{id:"B82",body:'Shah AS, Chen SH. Cataract surgery and diabetes. Curr Opin Ophthalmol. 2010:21(1):4-9. doi: 10.1097/ICU.0b013e328333e9c1.'},{id:"B83",body:'Haddad NM, Sun JK, Silva PS et al. Cataract surgery and its complications in diabetic patients. Rev Semin Ophthalmol 2014;29:329-337. DOI: 10.3109/08820538.2014.959197.'},{id:"B84",body:'Chew EY, Benson WE, Remaley NA et al. Results after lens extraction in patients with diabetic retinopathy; early treatment diabetic retinopathy study report number 25. Arch Ophthalmol 1999:117(12):1600-1606.'}],footnotes:[],contributors:[{corresp:null,contributorFullName:"Efraim Berco",address:null,affiliation:'
Ophthalmology Department, Kaplan Medical Center, Rehovot, Israel
Hebrew University and Hadassah Medical School, Jerusalem, Israel
Ophthalmology Department, Kaplan Medical Center, Rehovot, Israel
Hebrew University and Hadassah Medical School, Jerusalem, Israel
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1. Introduction
Children’s experiences with digital technologies actually involve an increasing quote of young users (also defined as “digital natives”) who are born and are developing in environments in which new digital technologies are widely available [1]. This currently occurs from early infancy, due to the rapid diffusion of touchscreen devices among younger children (or “touch generation”; [2, 3]). Children aged 2–4 years actually are able to use touchscreen devices, such as tablets or smartphones, to play or watch movies, and often parents themselves introduce kids to use them in boring social situations (i.e., in the pediatrician’s waiting rooms or in the restaurant; [4]). On the basis of the most recent report on worldwide diffusion of the Internet among young people [1], one in three users is estimated to be a child or teenager (under 18). Generally children use digital technologies in their home, particularly younger children, with intense and prolonged activities especially on weekends. Children often use their digital technologies at school at least a day a week (almost 30% among 9–11 years), although it is prohibited in many countries by school regulations. The access to digital technologies is expanding among young generations, even if many inequalities of resources remain between developed or developing countries [1]: for example, it has been estimated that in Africa (Ghana) children mainly use 0.9 mobile devices to connect to the Internet, against 2.9 in South America (Chile) or 2.6 in Europe (Italy). Similarly, only 12% of children in Africa (Ghana), 21% in the Philippines, and 26% in Albania can connect to the Internet at school, against 63–54% of children in other South America or European countries, such as Argentina, Uruguay, or Bulgaria. This reality raises several questions on how to guarantee the young generations the opportunities offered by new technologies (for studying, enhancing skills, socializing, etc.), protecting them from potential dangers of digitalized world (i.e., contacts with unknown people, exposure to violent/pornographic contents, etc.). In fact, although children grow in a reality permeated by new media, they are not automatically “digitally literate,” that is, able to juggle the digital world and to reflect on it. Studies show that not only young users, but also teenager users “have difficulties in finding, managing and evaluating information, managing their privacy online and ensuring their online personal safety […]and may thus vary in their digital skills” ([5], p. 186).
Together with their children, parents themselves are largely exposed to media experiences in many fields of their life. Digital technologies have quickly changed the way in which family members communicate, enjoy themselves, acquire information, and solve daily problems. Parents are also the first mediators of children’s experiences with digital tools: they have the task of integrating their use into ordinary routines (play, entertainment, learning, mealtime, etc.), promoting constructive and safety uses. Digital parenting describes parental efforts and practices for comprehending, supporting, and regulating children’s activities in digital environments. A growing research on digital parenting identified the main approaches that can allow parents to “mediate” children’s activities with digital technologies [6, 7, 8]. According to Vygotsky’s theory of child development and his concept of proximal development zone [9], parental mediation can be considered a key aspect in facilitating the interactions between children and new media. The proximal development zone is an intermediate area between what the child is able to do alone and what he/she can learn thanks to the guidance of others. In the course of a shared activity, the support and the help are adapted so that the child can improve his/her skills and gradually assume responsibility for acting alone. However, the activities that take place in the virtual environments of the web, unlike the experiences in the real environments, can reverse the relationship between the competent person (the adult) and the learner (the child). Today’s children have an early, almost “intuitive” approach to digital technologies, so in some cases they can become active agents towards their parents. When children’s knowledge and digital competence (e.g., functions/benefits of a new app) overcome that of parents, many shared experiences can be child-initiated, and children can also perform some forms of support and digital teaching to parents. This reverse socialization [10] seems to be a peculiar feature of digital experiences, and it poses new challenges to parental role. Reverse socialization describes all situations where children possess a better understanding or more advanced skills than adults. This gap between generations is more marked in low-income families or low-educated parents who possess limited resources and access to digital technologies [11]. However, over the past years, many parents have developed adequate knowledge and technical skills to share digital experiences with their children [3, 12]; they appreciate benefits of the web and strive to comprehend its complexity.
A common difficulty that parents actually encounter derives from the diffusion of “portable” devices (smartphone and tablet) that children start to use in early infancy (under the age of 2; [13]). Later, due to unlimited Wi-Fi access and enhanced connectivity, children insert activities with mobile devices into many daily routines, for example, during mealtime, school homework, conversations with parents, or before sleeping [14]. Particularly, parents worry about the “pervasiveness” (or ubiquitous) of mobile technologies in daily activities [15], and they fear that an effective guidance and control over them may decrease. Studies with large samples of young digital users (9–16 years old) in many European countries have compared parents’ opinions before (2010 Eu Kids Online Survey; [12]) and after (Net Children Go Mobile; [3]) the diffusion of mobile devices. After 4 years, many parents declare that they know less about their children’s online activities and have more difficulties to closely monitor children’s usage (e.g., time spent connected). Interestingly, parents now are more aware of the risks of using the web [16], and they prefer to talk to children about Internet security (e.g., do not leave personal data online or block unknown people) rather than limiting or prohibiting Internet use [17]. Parents can encourage or limit the use of digital technologies to children according to the opportunities or danger they attribute to them. Since parents themselves are regular, sometimes enthusiastic, users of digital media, their digital skills and confidence and daily frequency of usage (or overuse; [18]), together with beliefs about digital world [3], are all crucial factors that researchers have begun to explore systematically.
2. Parental beliefs
Each parent has beliefs, that is, convictions and personal opinions, regarding the usage of media by children, such as their usefulness or damage, or the age at which children should use them. Beliefs are the cognitive dimension of attitudes, guiding individual’s behavior and choices. When parents raise their children, they act and make choices for them following their own perceptions of what is desirable or what they positively value for their child’s development [19]. Although parents are not always aware of their beliefs, these influence parent-child interaction and the child’s opportunity to learn, do experiences [20], and develop digital skills [5]. Parental beliefs are important aspects of parenting and family microsystem, together with factors such as parent’s history and education, socioeconomic status, and culture.
Parents possess personal ideas about modern technologies: they can be considered a source of entertainment/relaxation or a learning tool [21, 22]; conversely, for other people, PC, tablet, and smartphone can be harmful to children’s health (such as sleep problems, obesity, etc.; [23]), for social risks (such as contacts with unfamiliar or social isolation; [24]), or because they interfere with parent-child activities and time spent together [25].
A qualitative study [26] shows that parents have more pessimistic (70.55%) than optimistic opinions (29.45%) on the Internet use by primary school children: for example, parents worry about the excessive time spent online, the interference in face-to-face conversation, or that children lack of skills and maturity in dealing with some contents suitable for older children (such as violence, sex, or drug-related contents). Other worries concern negative consequences on learning and academic performance (i.e., reduced attention span), physical development (i.e., prolonged sedentary activities), social skills and peer interactions (i.e., fewer opportunities to “learn to play together”), and child’s well-being (i.e., using smartphone to overcome boredom). Interestingly, many parents fear losing control over their children’s online behaviors. Conversely, the positive beliefs concern positive effects of digital technologies on child’s entertainment, communication and learning, access to information, and enhancing of child’s skills (such as brain functioning, self-regulation, autonomy, critical attitude, etc.).
Other researchers [27] explored parent’s perceptions about positive (i.e., they are shared by generations) or negative impact (i.e., they expose family privacy to risks) of social media—such as Facebook or WhatsApp—on family open communication. Teenagers are intensely involved in social media use, but adults also are regular users. On the one hand, parents use social networks to communicate; on the other hand, they fear that they negatively impact family relationships, for example, through the phubbing phenomenon (i.e., ignoring someone or interrupting a conversation or mealtime to check the smartphone). Authors found that parents’ perceptions are a meditational variable between the collective family efficacy (i.e., the perceived efficacy to manage family relationships, to support each other, etc.) and the openness of communication: “it is not only the actual impact of social media on family systems that matters but also parents’ perceptions about it and how much they feel able to manage their children’s social media use without damaging their family relationships” (p. 1).
Parental beliefs may influence the degree to which parents give opportunities or restrict their children’s media use, but beliefs should not be considered the “cause” of behavior towards children. Researches show that parents’ positive beliefs (e.g., “the tablet improves reading skills”) are associated with favorable attitudes, co-using approach, communication, or suggestions to enhance their child’s appropriate use of the Internet [28]. For example, when parents think that smartphones are useful tools (i.e., they promote child’s intelligence and knowledge), they more often allow their preschool children to use them (i.e., at the restaurant), and children become regular users, spending more time (at least 2 h a day) with smartphone activities [29]. Conversely, parents who attribute negative effects to digital media tend to limit activities to children (i.e., put time limits or react for smartphone overuse); in turn, these restrictive behaviors can influence how much the children use these devices [28]. Therefore, the influences of parental beliefs on child’s behaviors are not directed, but they are mediated by parental practices and other factors such as parental education or involvement with mobile device (“attachment”; see, e.g., [30]) that can intervene.
3. Parental media competence and self-efficacy
Parental beliefs include also self-efficacy [31, 32], that is, parent’s sense of competence in their own digital skills and in managing their children’s technology usage. An example of parental self-referent estimation of competence is “I won’t bother setting parental controls or passwords because my kids will “hack” around them” (cfr. [33]). In many studies, parental self-efficacy is positively associated with active parental practices: when parents feel confident about their Internet skills, they more often are involved in or monitor their children’s media activities [6]. Recently Shin [34] distinguishes general self-efficacy (the confidence to be a good parent; [35]) from two self-efficacy domains assessing parental beliefs more strictly related to digital tasks: parental “media competency” in using media technology (such as sending/receiving email with a smartphone) and “perceived control over mediation strategies” (the degree to which the parent feels to be able to guide or modify their children’s behaviors on smartphone). All these domains of parenting self-efficacy are associated with each other [34], suggesting that perceived competence on their own digital skills can positively influence parents’ involvement with children (e.g., discussing about smartphone use).
Sanders et al. [33] found that when parents are confident to have adequate digital skills, they more often intervene (i.e., with rules and reinforcement strategies) with their children. Parental self-efficacy also influences parental opinions about technologies and how they talk about them with children [33]. Moreover, parental perception of influence in managing technologies decreased with preadolescents that generally are seen as more self-regulated and reluctant to the parental control than younger children. These findings suggest the importance to recognize the influence of child characteristics (such as age, technology usage, perceived competence, etc.) on digital parenting.
4. Parenting approaches in children’s digital engagement
4.1 Parenting style
Initially studies on parental engagement in children’s activities with media assumed as theoretical basis the traditional parenting styles [36, 37]. According to Darling and Steinberg [38], parenting styles are defined as the context (or emotive climate) in which parents raise and socialize their children, and they are distinct from practices, that is, the distinct actions contingent to the child’s behavior (e.g., scolding when the child uses the smartphone during mealtime). As it is well known, two main dimensions of the parent’s behaviors, and their natural variations along a continuum, describe the styles: responsiveness/warmth (involvement, acceptance, and affect that the parent expresses towards the child’s needs) and demandingness/control (rules, control, and maturity expectations for the child’s socialization). Parenting styles derive from the combination of these variable dimensions: authoritative parenting (high warmth and high control, e.g., parents listen to the child’s wishes, but they put clear limits to the child’s behaviors); laissez-faire parenting (low warmth and low control; the parents are detached from the needs expressed by the child; they did not give rules or limits to child’s behavior); authoritarian parenting (low warmth and high control; parents expect the child to obey; they neither discuss nor listen to the child’s opinions and can react with harsh discipline); and permissive parenting (high warmth and low control; parents are very affectionate, but they lack in guidance through rules and give few limits to the child’s behavior).
Studies that applied these “classic” parenting styles to children’s behaviors with new communication media did not provide convincing results [39]. As an alternative to the “broad” parenting styles, a description of specific media-related practices is more useful in empirical studies for exploring the link between parental behaviors and child outcomes (e.g., time spent online). Therefore, researchers strove to identify the key dimensions of parental warmth/control more strictly referred to children’s behaviors on the Internet or new media (Table 1). These Internet parenting styles are more strictly linked to children’s actual use of digital technologies, for example, low parental control predicted more time of Internet usage by school-aged children [8].
Style dimensions
Item (examples)
Parental control
Supervision: “I’m around when my child surfs on the Internet”
Stopping internet usage: “I stop my child when he/she visits a less suitable website”
Internet usage rules: “I limit the time my child is allowed in the Internet (e.g., only 1 h a day)”
Parental warmth
Communication: “I talk with my child about the dangers related to the Internet (costs, addiction to games, computer viruses, privacy violation, etc.)”
Support: “I show my child “child friendly” websites (library, songs, crafts, school website, etc.)”
Table 1.
Dimensions of the internet parenting style (adapted from [8], p. 89).
Parenting style dimensions seem influenced by parents’ individual characteristics such as gender, instruction, beliefs, or prior experiences with digital technologies. For example, in Valcke et al. [8] study, mothers are more controlling but also warmer than fathers, both dimensions associated with an authoritative style. In other studies, younger fathers and those who use the Internet more frequently with their teenagers are higher in control [40]. Parental instruction and experiences with digital technologies are other important variables: higher educated parents are more involved and high in control, probably because higher instructional levels also correspond to greater parents’ competence with the Internet [8].
The first studies explored parenting styles related to Internet usage at home, but more recently other authors explored the influence of digital parenting styles on children’s usage of mobile devices (tablet and smartphone). Konok et al. [30] found that children (3–7 years old) who use the devices for more time every day have parents who are more permissive (e.g., they talk with children about applications on devices, but have low levels of demandingness), more authoritative (e.g., they give time limits, but they do not block the use because they expect the child to regulate himself), and less authoritarian (i.e., the parent restricts and prohibits mobile use). Interestingly, these parenting styles are also associated with parental beliefs about positive/negative consequences of early media usage: parents who have higher permissive or authoritative digital style declared more beneficial (i.e., skill improvement, entertainment, and early learning of digital skills) than negative effects (i.e., reduced time for other activities, developmental problems, and danger/addiction) for children’s mobile usage.
Digital parenting styles change also according to children’s characteristics, such as age [41], self-esteem [42], emotion regulation [43], or behavioral problems [44] that can intervene, mediating the link between parenting and children’s actual behavior with digital technologies. Particularly, styles vary and accommodate with children’s age: authoritative parents during infancy become more permissive with older children [41]. Overall, these findings reappraise the idea that there is a linear, cause-effect relationship between parenting and child outcomes on digital behaviors, but bidirectional and transactional parent-child influences [45] should be considered.
4.2 Parental mediation
Alternatively to digital parenting styles, many researchers adopted parental mediation as perspective for exploring parental influences on children’s digital behaviors. Parental mediation refers to “the diverse practices through which parents try to manage and regulate their children’s experiences with the media” ([7], p. 7). Parental mediation strategies were initially introduced in empirical studies as a potential factor influencing children’s use of television [46] and videogames [47]. These studies, exploring how parents can effectively reduce excessive exposure or enhance children’s self-regulated behaviors, inspired the following researches on digital technologies. Actually in literature two broad mediation approaches are distinct: enabling (or instructive) mediation and restrictive mediation [16]. These strategies are only partially similar to those parents who adopt “traditional” media: for example, co-viewing is a mediation strategy generally applied to television use [48], but it is difficult to apply it to portable media (particularly, smartphone and tablet) that children often use alone or outside the home environment. As a consequence, parents can feel worried because they cannot effectively control their children’s media use and involvement in digital life [11, 49].
The (a) enabling mediation is also defined as “active” or “instructive mediation” in that parents engage different activities with the aim to enhance their child’s appropriate use of the digital technologies: for example, they explain to him/her how to use a media device, talk about the contents of new app/websites, or play a videogame together (co-use mediation). Nevertheless, in many empirical studies, (b) co-use (or co-viewing mediation) does not imply parent-child conversations, but the parent is present when the child displays the activity with the media without discussing the content [13]. The (c) restrictive mediation is characterized by a strict attention to rules and control to the child’s digital activities: for example, parents decide when the child can have his/her tablet, pose time restrictions, or react when the child uses the smartphone too long. The (d) technical restriction is a particular kind of restrictive approach adopting software applications or other technical tools to control the child’s activities (e.g., installing filters on PC for children’s safety). Nevertheless, parents rarely use them and declare they prefer child-directed strategies, such as giving explanations or sharing the device [6].
Active mediation is the most frequent approach adopted in European families with 9–16 years old children, whereas restrictive mediation strategies are more common with younger children [16]. Interestingly, when children are interviewed about the mediation approach adopted in the family, they agree with their parents’ responses [12].
All mediation strategies are linked with changes in children’s digital behaviors, for example, less time exposure with online activities [12], or reduction of negative outcomes (i.e., aggressive behaviors, overuse, etc.; see [50]), but their efficacy is relative and it changes as a function of the child’s development (i.e., age and digital skills) and his/her actual activity with media. Active mediation is linked with positive outcomes (such as social and cognitive skills), particularly with younger children (0–3 ages): for example, during video/movie watching, parents stimulate attention, comment, or pose questions to children, giving them occasions for language exposure and cognitive and digital learning [51]. Nevertheless, we cannot link children’s outcomes uniquely to a distinct mediation strategy, since parent-child interactions are complex and many contextual or individual factors can intervene. Parents often use a combination of mediation strategies, and they change the mediation approach according to the activity the child is doing (e.g., using the tablet for school homework or for visiting Facebook; [11]).
Other authors explored the influence of family sociocultural factors. For mediation to be effective to guide children’s experiences in the web, parents need to have themselves knowledge and skills of the new digital media (see Section 4 in this chapter). Particularly in conditions of sociocultural disadvantage, parents may lack basic digital skills [52], or they may not be able to explain to children how digital reality works and rapidly changes [53]. Unlike the traditional media (such as television or video game console), parents can give a difficult task to assure a help or guide children with the ever-changing technologies. Recently, Nikken and Opree [11] found that mostly low-educated, low-income, and single parents are likely to experience low competence and greater insecurity with new devices (such as electronic screen), declaring that it is difficult to apply co-use or active mediation strategies with their young children (1–9 ages). In addition, Warren and Aloia [49] found that when parents perceive high stress levels, the restrictive mediation and the discussions with children about contents and the use of media increase.
Parental mediation strategies may change according to their child’s age and his/her digital skills, but longitudinal studies are scarce in literature. Developmental changes have been observed from childhood to adolescence: active mediation strategies more often are adopted with younger children, whereas restrictive mediation fades with older and adolescents [17]. Parents generally expect greater autonomy and self-regulation skills from adolescents, and the influence of some parental strategies decrease over time: for example, the efficacy of restrictive strategies (i.e., rules for time or negative consequences for overuse) in reducing screen time decreases with older children [33]. From a developmental perspective, particularly the effects of restrictive approach are unclear. Some studies evidence that restrictive strategies (such as limiting access to media) are effective with younger children [6], but not with older kids. Adolescents can perceive parental control/limitations as a violation of their needs (i.e., self-determination, privacy, peer relationships, etc.) and react with increased online activities [54].
After all, parents wish their children can develop self-regulation, critical view, and awareness of opportunities or risks of digital technologies. In many studies, parental active mediation—for example, discussing with children issues such as cyberbullying, sexting, and online frauds—is more effective than restrictive mediation in reducing risks [16, 55]. Conversely, the efficacy of restrictive mediation must be considered relatively, since in literature both positive and negative associations with online risks emerge [56]. Mascheroni et al. [57] comment, “While restrictive mediation can be effective in reducing children’s exposure to online risks, it has numerous side-effects, because it limits children’s opportunities to develop digital literacy and build resilience and discourages children’s agency within the child-parent relationship. Enabling mediation, instead, encompasses a set of mediation practices (including co-use, active mediation of internet safety, monitoring and technical restrictions such as parental controls) that are aimed at empowering children and supporting their active engagement with online media. The question is, then, how to ensure children’s access to online opportunities while protecting them from potential harmful effects.”
Interestingly, parents adopt their approach according to their child’s competence in digital technology use (digital literacy). In line with a bidirectional model of parent-child influences [45], not only parenting influences child’s behaviors, but also the child’s actual behavior or perceived digital competence influences parental behaviors. Generally, restrictive mediation strategies are more often adopted with less digitally skilled children, but this approach could be counterproductive: limiting online activities for protecting the child from risks, in turn, can deprive him/her to opportunities for developing adequate digital skills [5]. Conversely, parents more often use active mediation strategies (e.g., they share experiences or talk about media) with skilled children than with children who have scarce competencies [58].
5. Parental worries about children’s online activities
The predominance of online activities in the life of many children often worries parents, who observe that spending much time online removes children from face-to-face relationships and social activities. Empirical studies confirm the negative effects of Internet unsuitable use on social participation, since high levels of online activities are associated with few friends, reduced offline relationships [59], and increased loneliness [60]. Particularly loneliness, that is, social isolation and lack of intimacy with close friends, was found to be strongly associated with Internet excessive use [61]. However, causal relationship between Internet excessive use and loneliness is still under investigation [62], in an attempt to understand if loneliness can be the antecedent or the consequence of the individual’s excessive involvement with Internet activities. Two alternative hypotheses have been proposed to explain the link between poor social involvement, feeling lonely, and the development of problematic Internet use in children. According to the first hypothesis, loneliness is one of the main antecedents of excessive online activities, together with low self-esteem, poor social skills, social anxiety, and frequent conflict with parents. Some authors (e.g., [63]) hypothesized that adolescents who feel lonely or experience high anxiety in face-to-face social situations may use social networks and online exchanges more frequently than non-lonely adolescents. According to this “compensation hypothesis,” they are increasingly involved in Internet activities that provide alternative experiences for social life. The second hypothesis assumes that time spent online causes loneliness and social withdrawal, isolating and depriving people of real social experiences. Therefore, loneliness can be considered as a possible outcome of Internet overuse [64], like when prolonged activities online reduce time spent with family and friends. Finally, there are studies that did not confirm the link between loneliness and Internet problematic use [65] or that evidence some positive consequences on individual socioemotional well-being. For example, contradicting the assumption that using the web impoverishes social life and increases isolation, in some studies higher levels of Internet activities are positively associated with social connection and perceived support. Unfortunately studies with children and adolescents are still lacking, but the attention among researchers is growing [60, 66].
Given the paucity of research with adolescents, we conducted an unpublished study1 to explore the relationships among excessive Internet use, preferred online activities, and adolescent’s perceived loneliness. In addition, we hypothesized that among adolescents better parent-child communication and higher parental emotional availability were positively related with less time spent online and less frequent online activities. In fact, studies indicate that parent-child communication and parental involvement play a protective role to excessive online activities [67]. A community sample of 177 high school students (66% females), aged 16–22 years old (M = 18, DS = 1.01), completed a questionnaire measuring the sense of loneliness (UCLA Loneliness Scale; [68]) and the Compulsive Internet Use2 Scale (CIUS, [69]) for assessing problematic involvement in Internet activities. Daily frequency of favorite online activities (chatting, e-mailing, visiting social networking sites, listening to music, watching videos, playing online games, etc.) was also measured. Regarding parenting factors, adolescents filled out (a) the Lum Emotional Availability of Parents questionnaire (LEAP; [71]) assessing adolescent’s perception of parental responsiveness, sensitivity, and emotional involvement and (b) two scales (derived from [70]) measuring the frequency of communication (how often the adolescent communicates with parents about his/her online activities) and the quality of parent-child communication (the adolescent feels understood, or comforted, or taking seriously from parents when he/she talks about Internet activities). In our study loneliness was not associated with Internet compulsive use (CIUS scores), but with specific online activities. Adolescents with higher loneliness levels reported higher frequency of music listening, but they declared less access to social networks (such as Facebook). This result contradicts the hypothesis of social compensation assuming that the teenagers use online exchanges to replace the sense of loneliness in real life [61]. An alternative explanation, proposed by others [72] is that a process downward with a “spiral pattern” is activated: loneliness leads to a decrease in social involvement which in turn increases the sense of isolation. Interestingly, those who spent more time online and were problematic users (higher CIUS scores) were more frequently involved in solitary activities, such as watching videos, listening to music, playing games offline, and visiting social networking sites. Perceived emotional availability from the father (but not from the mother) was negatively related with time that adolescents spent online. Teenagers who perceived greater emotional availability from both parents used the Internet more often for working on school projects and homework or doing search. A better quality of communication with parents is associated with less use of the Internet for gambling and online games. Overall these results confirm a virtuous relationship between quality of family communication, emotional availability of parents, and productive use of the web.
6. Family communication and parental consistency for preventing risks
An interesting evidence emerging from empirical literature is the protective role of parent-child communication for preventing Internet unsuitable use in children [73]. Conversely, Internet excessive use is associated with low quality of communication in the family [74]. Particularly with teenagers, the open and effective parent-child communication is a key dimension of family relationships and climate. Assuming a bidirectional perspective of adolescent-child influences, some authors focus on the role of youths’ self-disclosure and spontaneous communication on parenting. Stattin and Kerr [75] claim that parental efforts to monitor adolescent’s activities or to discuss about them are ineffective if teenagers do not trust their parents and if they are not willing to open up spontaneously. Parental monitoring on children’s activities can be less effective when it is parent-driven (e.g., the parent tries to follow the child’s activities on Facebook) than when it is child-driven, that is, activated by children’s self-disclosure and open communication. Conversely, when parents try to control teenagers’ online communication (e.g., the friends on Facebook, the photos posted on Instagram, etc.), parent-child conflicts increase, and adolescents can perceive parental behaviors as an obstacle to their autonomy or an intrusion to privacy [76].
Van den Eijnden et al. [70] identify two key dimensions of parent-child communication about children’s digital behaviors. The first parenting practice refers to the frequency of communication about Internet usage (e.g., “How often do you and your parents talk about who you have Internet contact with?”), whereas the quality of communication about Internet use measures adolescent’s perception of mutual respect and acceptance during conversation (“When my parents and I talk about my Internet use, I feel taken seriously”). Authors explore how these parental behaviors, together with other Internet-specific parental practices (rules about time online, rules about contents, reactions to excessive use), link to compulsive Internet use (CIU) in adolescents. Findings from their longitudinal study are particularly interesting, showing a protective effect of the quality of communication, but not of frequency of communication, on the risk of developing CIU. In other words, a good quality of parent-child communication about the use of Internet decreased the risk of CIU (6 months later), whereas this relationship was not observed for the frequency of parent-child exchanges about adolescent’s online activities. Authors discuss these findings by highlighting the bidirectional nature of parent-child influences. When adolescents show compulsive Internet behaviors, the frequency of parent-child communication decreases. Probably gradually parents get discouraged and give up the idea of achieving a positive change in their child’s problematic behaviors through frequent conversations.
Regarding the parental rules about online activities, studies evidence some mixed results. When parents give their children rules about the content of the Internet, the compulsive use of web decreases; conversely, strict rules about time allowed for online activities seem to be counterproductive, linking to compulsive Internet behaviors in children [70]. Moreover, considering the child’s influences on parent’s behaviors, it is possible that when the child remains connected online without time limits, her/his behavior in turn stimulates stricter rules by parents. Other studies evidence that parental rules about Internet use are less influential on their children’s behaviors than their parents’ behaviors. Liu et al. [77] found that when parental behaviors are consistent with parental rules regarding digital technologies and the Internet (e.g., the smartphone must not be used during mealtime, personal data cannot be given online, etc.), the rules negatively predict Internet problematic use in adolescents. This result reminds us the importance of educational consistency (i.e., rule-behavior agreement) from parents. Conversely, when parental rules and parental behaviors do not agree, only the parents’ behaviors are positively predictive of children’s excessive Internet use. According to social learning theory [78], a parental modeling process intervenes, that is, an observational learning in which the parent’s behavior acts as antecedent for similar behavior in the child. Therefore, parents act as a role model for their children’s digital behaviors, and young children learn how and under what circumstances to use a mobile, for example, the smartphone, observing parents’ activities with that device. Interestingly, studies show that the time parents spend with computers positively relates with time spent by their children [79]. Similarly, parental involvement in favorite Internet activities (visiting social networking sites, video streaming, etc.) is positively associated with the same activities engaged by children. In addition, as some researchers remind us “it is not only overt parental behavior (i.e., digital device use) but also attitudes and emotions that can be modelled for children to imitate” ([30], p. 4). Taken together, these findings suggest that parents’ agreement and modeling of adequate behaviors are crucial factors for promoting self-regulation and safety use of digital technologies in young children.
7. Conclusions
Today’s reality is widely digitized, and it offers people of all ages opportunities for socialization, amusement, learning, job, and knowledge that were unthinkable until a few decades ago. Precisely in the weeks in which the authors were engaged in the revision of this chapter, COVID-19 pandemic was involving more than 130 countries in the world. The lockdown and restrictions at home quickly changed daily activities of children and parents, transferring to the screen of the devices many activities previously carried outdoor (school lessons, play with peers, etc.). It is still too early to know what impact the epidemic will have on children’s physical and mental health, but the attention of professionals and researchers is not lacking [80]. Surely during COVID-19 screen time has increased exponentially in the families: in some ways for the parents it was a relief, because through the Internet children continued their school courses and contact with peers. In addition, children avoided boredom through videogames or website dedicated to music, creativity, etc. On the other hand, the intensive online activities have renewed parents’ concerns about the well-known risks [23, 81], such as increased sedentary and physical inactivity, prolonged use at night, sleep disorders, isolation, and escape in digital world by teenagers.
Following social distancing and the temporary closure of schools for limiting COVID-19 infection, the Ministries of Education in many developed countries quickly activated online courses and other websites for distance learning. These online solutions have the aim to guarantee children’s right of instruction but also to mitigate the negative effects of home confinement [82]. However, online courses shift the teaching from school to home and make the parents a resource for support and effective learning. The question is: what can be the role of parental mediation and digital competence? As the authors know, there are no empirical studies on this topic, but previous studies with primary school children showed negative associations between parental control, interference in homework, and children’s learning [83]. Currently, in many cases teachers expect parents to ensure that their children connect on time and follow the video lessons, so parental support could be useful, but tensions and parent-child conflicts can also occur. There is also the risk that parents may help children, interfering with digital learning or impeding them from carrying out the assigned activities independently. Close attention and research effort are needed for comprehending how this aspect of digital parenting works, supporting parents in their efforts and ensuring a good home learning to children.
In line with the available studies before COVID-19 [4], we believe that during lockdown the digital activities satisfy children’s basic psychological needs, such as socialization and emotional support by the family (grandparents and cousins) and other significant people (teachers and peers). Social media facilitate the expression of emotions (such as fear and sadness), self-disclosure, and the keeping of romantic relationships by adolescents particularly [84]. Video calling and regular contacts through smartphone have been recommended as an important source of reassurance in the cases of isolation of the caregiver or family due to prevention of COVID-19 infection or recovery [85].
What probably becomes necessary in the time of COVID-19 is a renegotiation of family routines, that is, a balance between screen time and other moments of family life. In this regard, the WHO [85] recommends that parents maintain regular routines for children (school/learning, free time/relaxing, bedtime, etc.) and also to create new opportunities for joint activities (such as co-use for creative, amusing, or physical activity in front of the screen). With young children, many shared activities offer also a context to express and communicate their feelings (both fears and wishes) in a supportive parental relationship. Even in actual COVID-19 circumstances, we believe that parental behaviors (such as self-limiting screen time for smart working, chatting, or gaming) are more influential than restrictive mediation or limitations imposed to children.
Having the digital knowledge and the skills to move in the digital world, without suffering the dangers, is not a matter of age, but of education and learning, that is, digital literacy. It is a serious responsibility towards the new generations and a complex challenge for which the adults (parents, teachers, psychologists, or educators) do not feel prepared. As Martin ([86], p. 135) reminds us: “Digital literacy is the awareness, attitude and ability of individuals to appropriately use digital tools and facilities to identify, access, manage, integrate, evaluate, analyze and synthesize digital resources, construct new knowledge, create media expressions, and communicate with others, in the context of specific life situations, in order to enable constructive social action; and to reflect upon this process.” Currently, parents’ difficulties stem from the fact that they—as digital users—have different levels of involvement, technical skills, and beliefs that influence mediation practices towards their children. If parents feel less skilled or worry about unknown dangers of the web, they could activate more restrictive practices, but rarely they will be able to critically discuss with their children in a constructive manner. In addition, parents believe not to be up to their children in juggling in the digital world, in pursuing technological innovations, or in protecting children from danger or media abuse. Sometimes parents consult the websites for suggestions on how to effectively manage kids in their digital activities, but information disseminated through the websites is not always scientifically founded (fake news). The researcher Danah Boyd [87], in describing the complexity (“It’s complicated”) of teenagers’ life on the web, claims that the media magnify the virtues (the “superpowers”) of digital natives, but at the same time they trigger parental fears talking about serious dangers such as Internet addiction, sexual enticement, or incitement to suicide. Conversely, rarely parents turn to professionals for advice. A study [28] conducted with families of very young children (under 7 years) shows that parents choose the type of help (professionals such as pediatricians, or friends and family) based on the child’s problems and his/her digital activities. The professionals are consulted if the child is an only son or he/she uses the media too long. Parental sense of competence in managing the child’s activities increases if parents are confident of the usefulness of the media (e.g., educational games for learning) and if there are more kids in the family. Parents turn to friends and family for advice when they have a negative view of the effects of the media. This result makes us reflect, but unfortunately there are not many similar studies.
A correct parental mediation of children’s digital activity must build on the information and recommendations that come from the scientific community. The American Academy of Pediatrics [2] has taken a clear stance for prudent and moderate use of the web in infancy (0–5 years) and has prohibited touchscreen device use under the age of 2. The careful use of these devices at such an early age is crucial for the infants’ brain and social development. However, in contrast to these professional recommendations, often parents themselves introduce babies to media use during infancy (e.g., to “take calm” the kid, or to stop whims and cry; [30]). Young children spent daily an amount of time with screen media (iPod, smartphone, video game player, etc.) that grows during infancy (42 min under 2 years and 2 h/39 min at 2–4 years, respectively; [88]). The risks for excessive screen exposure are extensively confirmed in literature and particularly the negative consequences for early users who may present physical problems (such as obesity), developmental difficulties (i.e., language or learning), and unhealthy routines (low sleep quality) (Figure 1).
Figure 1.
Developmental risks associated with excessive media exposure (from [88]).
The recommendations for effective parental mediation on children’s digital activities are unequivocal [2]: (a) avoid the use of digital devices before 18–24 months with the exception of video chatting in the presence of the parent; (b) do not allow the child (18–24 months older) to use the devices alone and for more than 1 h a day; (c) do not press for an early use, the child will spontaneously approach the media when ready; (d) help the child apply what he/she learns from using the device to the real world; (e) know that in infancy, direct experiences, manipulation, and unstructured play are crucial for the child’s brain and for social, cognitive, and linguistic development; (f) void the vision of fast programs, with too many distracting elements, or violent contents that the child is unable to understand; (g) avoid using devices to calm the baby, an hour before bedtime; and (h) constantly monitor the media contents to which the child is exposed. Finally, the experts (pediatricians and psychologists) turn also to the industry that produces media devices, so that it adopts a scientifically founded and more ethical approach, for example, installing apps (such as connection stop or automatic shutdown during night hours) that can protect very young children from the risks of overuse.
Therefore, parent education interventions are necessary both to disseminate scientific knowledge on the influence of new technologies on children’s health and development and to help parents to cope with the challenges of digital reality. Parent education cannot be reduced to merely correcting ineffective parenting practices or to a list of instructions on what the parent should do. In fact, all studies indicate that the effectiveness of mediation strategies (restrictive or active approach) is relative, because parental practices interact with the characteristics of both adults (digital skills, beliefs, and activities on the media) and children (age, development, digital literacy skills, etc.). Instead, professionals should help parents to improve and adjust their guidance according to children’s age and developing skills. This is possible to be realized if parents also increase their knowledge and digital skills (media literacy programs), given the importance of these factors in parenting. Less skilled parents, or those who fear the unknown pitfalls of the web, are more likely to intervene only on restricting or prohibiting children’s activities. Conversely, “it is likely that more skilled children and parents are more free to explore and benefit from online opportunities, while also building up resilience against harm by meeting a degree of online risk” ([16], p. 19).
Digital parenting is a very complex and “complicated” task not only because the digital technologies rapidly change, but also because they offer children multiple experiences (learning, communication, socialization, entertainment, etc.) that influence their development, but which are not entirely overlapping to the experiences that take place in the real environment [89]. Particularly, digital natives have the opportunity to know the reality and themselves, developing their own identity [76], with a multiplicity of means and without the supervision of the traditional agents of socialization, primarily the parents (or the teachers). With the awareness of how difficult it is to give definitive answers about the advantages or dangers of digital technologies, more effort is needed from researchers. More evidence-based studies are needed, to understand how technological progress is changing the psychological (neurocognitive, emotional, and social) development of young digital users. However, despite the growing diffusion of digital tools in infancy, studies with very young children are still lacking. Particularly, future research could benefit from longitudinal studies to which to explore the relationships between parenting and children’s experiences in digital environments, their opportunities, or risks.
\n',keywords:"digital technologies, parental practices, parental beliefs, children’s digital literacy",chapterPDFUrl:"https://cdn.intechopen.com/pdfs/72249.pdf",chapterXML:"https://mts.intechopen.com/source/xml/72249.xml",downloadPdfUrl:"/chapter/pdf-download/72249",previewPdfUrl:"/chapter/pdf-preview/72249",totalDownloads:504,totalViews:0,totalCrossrefCites:0,dateSubmitted:"October 31st 2019",dateReviewed:"April 16th 2020",datePrePublished:"May 20th 2020",datePublished:"January 27th 2021",dateFinished:"May 20th 2020",readingETA:"0",abstract:"Digital media have quickly changed ways in which parents and children communicate, enjoy themselves, acquire information, and solve problems daily (both in ordinary and exceptional circumstances such as COVID-19 home confinement). Very young children are regular users of smartphones and tablet, so their early digital engagement poses new challenges to parent-child relationships and parental role. First, the chapter introduces the “digital parenting” construct, moving through the literature from “traditional” parenting styles to more recent studies on “parental mediation,” that is, the different behaviors parents adopt to regulate children’s engagement with the Internet and digital media. Second, the chapter reviews empirical researches on different parental mediation practices (active or restrictive behaviors) and how they are adjusted according to the child’s characteristics (age, digital competences, etc.) or parent’s media competence and beliefs. Finally, from a bidirectional perspective of parent-child relationships, the chapter discusses the role of youths’ social involvement, communication, self-disclosure, and digital skills on parent’s beliefs and practices. Implications for parent education and prevention of risks for early and excessive exposure to digital technologies are discussed.",reviewType:"peer-reviewed",bibtexUrl:"/chapter/bibtex/72249",risUrl:"/chapter/ris/72249",signatures:"Loredana Benedetto and Massimo Ingrassia",book:{id:"9043",title:"Parenting",subtitle:"Studies by an Ecocultural and Transactional Perspective",fullTitle:"Parenting - Studies by an Ecocultural and Transactional Perspective",slug:"parenting-studies-by-an-ecocultural-and-transactional-perspective",publishedDate:"January 27th 2021",bookSignature:"Loredana Benedetto and Massimo Ingrassia",coverURL:"https://cdn.intechopen.com/books/images_new/9043.jpg",licenceType:"CC BY 3.0",editedByType:"Edited by",editors:[{id:"193200",title:"Prof.",name:"Loredana",middleName:null,surname:"Benedetto",slug:"loredana-benedetto",fullName:"Loredana Benedetto"}],productType:{id:"1",title:"Edited Volume",chapterContentType:"chapter",authoredCaption:"Edited by"}},authors:[{id:"193200",title:"Prof.",name:"Loredana",middleName:null,surname:"Benedetto",fullName:"Loredana Benedetto",slug:"loredana-benedetto",email:"lbenedetto@unime.it",position:null,institution:{name:"University of Messina",institutionURL:null,country:{name:"Italy"}}},{id:"193901",title:"Prof.",name:"Massimo",middleName:null,surname:"Ingrassia",fullName:"Massimo Ingrassia",slug:"massimo-ingrassia",email:"massimo.ingrassia@unime.it",position:null,institution:{name:"University of Messina",institutionURL:null,country:{name:"Italy"}}}],sections:[{id:"sec_1",title:"1. Introduction",level:"1"},{id:"sec_2",title:"2. Parental beliefs",level:"1"},{id:"sec_3",title:"3. Parental media competence and self-efficacy",level:"1"},{id:"sec_4",title:"4. Parenting approaches in children’s digital engagement",level:"1"},{id:"sec_4_2",title:"4.1 Parenting style",level:"2"},{id:"sec_5_2",title:"4.2 Parental mediation",level:"2"},{id:"sec_7",title:"5. Parental worries about children’s online activities",level:"1"},{id:"sec_8",title:"6. Family communication and parental consistency for preventing risks",level:"1"},{id:"sec_9",title:"7. Conclusions",level:"1"}],chapterReferences:[{id:"B1",body:'Livingstone S, Kardefelt WD, Hussein M. Global Kids Online: Comparative Report. Florence: UNICEF Office of Research – Innocenti; 2019. Available from: www.unicef-irc.org/publications/1059-global-kids-online-comparative-report.html'},{id:"B2",body:'American Academy of Pediatrics (AAP), Council on Communications and Media. Media and young minds. 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University of Messina (Italy)."},{id:"fn2",explanation:'According to accepted criteria, compulsive internet use (CIU) is defined by the following characteristics [69]: "(1) continuation of internet use despite the intention or desire to stop or cut down; (2) experiencing unpleasant emotions when internet use is impossible; (3) using the internet to escape from negative feelings; (4) internet use dominating one’s cognitions and behaviors; and (5) internet use resulting in conflict with others or in self-conflict" (see [70]. p. 78).'}],contributors:[{corresp:null,contributorFullName:"Loredana Benedetto",address:null,affiliation:'
Department of Clinical and Experimental Medicine, University of Messina, Italy
Department of Clinical and Experimental Medicine, University of Messina, Italy
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The company was founded in Vienna in 2004 by Alex Lazinica and Vedran Kordic, two PhD students researching robotics. While completing our PhDs, we found it difficult to access the research we needed. So, we decided to create a new Open Access publisher. A better one, where researchers like us could find the information they needed easily. The result is IntechOpen, an Open Access publisher that puts the academic needs of the researchers before the business interests of publishers.
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We started by publishing journals and books from the fields of science we were most familiar with - AI, robotics, manufacturing and operations research. Through our growing network of institutions and authors, we soon expanded into related fields like environmental engineering, nanotechnology, computer science, renewable energy and electrical engineering, Today, we are the world’s largest Open Access publisher of scientific research, with over 4,200 books and 54,000 scientific works including peer-reviewed content from more than 116,000 scientists spanning 161 countries. Our authors range from globally-renowned Nobel Prize winners to up-and-coming researchers at the cutting edge of scientific discovery.
\\n\\n
In the same year that IntechOpen was founded, we launched what was at the time the first ever Open Access, peer-reviewed journal in its field: the International Journal of Advanced Robotic Systems (IJARS).
\\n\\n
The IntechOpen timeline
\\n\\n
2004
\\n\\n
\\n\\t
Intech Open is founded in Vienna, Austria, by Alex Lazinica and Vedran Kordic, two PhD students, and their first Open Access journals and books are published.
\\n\\t
Alex and Vedran launch the first Open Access, peer-reviewed robotics journal and IntechOpen’s flagship publication, the International Journal of Advanced Robotic Systems (IJARS).
\\n
\\n\\n
2005
\\n\\n
\\n\\t
IntechOpen publishes its first Open Access book: Cutting Edge Robotics.
\\n
\\n\\n
2006
\\n\\n
\\n\\t
IntechOpen publishes a special issue of IJARS, featuring contributions from NASA scientists regarding the Mars Exploration Rover missions.
\\n
\\n\\n
2008
\\n\\n
\\n\\t
Downloads milestone: 200,000 downloads reached
\\n
\\n\\n
2009
\\n\\n
\\n\\t
Publishing milestone: the first 100 Open Access STM books are published
\\n
\\n\\n
2010
\\n\\n
\\n\\t
Downloads milestone: one million downloads reached
\\n\\t
IntechOpen expands its book publishing into a new field: medicine.
\\n
\\n\\n
2011
\\n\\n
\\n\\t
Publishing milestone: More than five million downloads reached
\\n\\t
IntechOpen publishes 1996 Nobel Prize in Chemistry winner Harold W. Kroto’s “Strategies to Successfully Cross-Link Carbon Nanotubes”. Find it here.
\\n\\t
IntechOpen and TBI collaborate on a project to explore the changing needs of researchers and the evolving ways that they discover, publish and exchange information. The result is the survey “Author Attitudes Towards Open Access Publishing: A Market Research Program”.
\\n\\t
IntechOpen hosts SHOW - Share Open Access Worldwide; a series of lectures, debates, round-tables and events to bring people together in discussion of open source principles, intellectual property, content licensing innovations, remixed and shared culture and free knowledge.
\\n
\\n\\n
2012
\\n\\n
\\n\\t
Publishing milestone: 10 million downloads reached
\\n\\t
IntechOpen holds Interact2012, a free series of workshops held by figureheads of the scientific community including Professor Hiroshi Ishiguro, director of the Intelligent Robotics Laboratory, who took the audience through some of the most impressive human-robot interactions observed in his lab.
\\n
\\n\\n
2013
\\n\\n
\\n\\t
IntechOpen joins the Committee on Publication Ethics (COPE) as part of a commitment to guaranteeing the highest standards of publishing.
\\n
\\n\\n
2014
\\n\\n
\\n\\t
IntechOpen turns 10, with more than 30 million downloads to date.
\\n\\t
IntechOpen appoints its first Regional Representatives - members of the team situated around the world dedicated to increasing the visibility of our authors’ published work within their local scientific communities.
\\n
\\n\\n
2015
\\n\\n
\\n\\t
Downloads milestone: More than 70 million downloads reached, more than doubling since the previous year.
\\n\\t
Publishing milestone: IntechOpen publishes its 2,500th book and 40,000th Open Access chapter, reaching 20,000 citations in Thomson Reuters ISI Web of Science.
\\n\\t
40 IntechOpen authors are included in the top one per cent of the world’s most-cited researchers.
\\n\\t
Thomson Reuters’ ISI Web of Science Book Citation Index begins indexing IntechOpen’s books in its database.
\\n
\\n\\n
2016
\\n\\n
\\n\\t
IntechOpen is identified as a world leader in Simba Information’s Open Access Book Publishing 2016-2020 report and forecast. IntechOpen came in as the world’s largest Open Access book publisher by title count.
\\n
\\n\\n
2017
\\n\\n
\\n\\t
Downloads milestone: IntechOpen reaches more than 100 million downloads
\\n\\t
Publishing milestone: IntechOpen publishes its 3,000th Open Access book, making it the largest Open Access book collection in the world
We started by publishing journals and books from the fields of science we were most familiar with - AI, robotics, manufacturing and operations research. Through our growing network of institutions and authors, we soon expanded into related fields like environmental engineering, nanotechnology, computer science, renewable energy and electrical engineering, Today, we are the world’s largest Open Access publisher of scientific research, with over 4,200 books and 54,000 scientific works including peer-reviewed content from more than 116,000 scientists spanning 161 countries. Our authors range from globally-renowned Nobel Prize winners to up-and-coming researchers at the cutting edge of scientific discovery.
\n\n
In the same year that IntechOpen was founded, we launched what was at the time the first ever Open Access, peer-reviewed journal in its field: the International Journal of Advanced Robotic Systems (IJARS).
\n\n
The IntechOpen timeline
\n\n
2004
\n\n
\n\t
Intech Open is founded in Vienna, Austria, by Alex Lazinica and Vedran Kordic, two PhD students, and their first Open Access journals and books are published.
\n\t
Alex and Vedran launch the first Open Access, peer-reviewed robotics journal and IntechOpen’s flagship publication, the International Journal of Advanced Robotic Systems (IJARS).
\n
\n\n
2005
\n\n
\n\t
IntechOpen publishes its first Open Access book: Cutting Edge Robotics.
\n
\n\n
2006
\n\n
\n\t
IntechOpen publishes a special issue of IJARS, featuring contributions from NASA scientists regarding the Mars Exploration Rover missions.
\n
\n\n
2008
\n\n
\n\t
Downloads milestone: 200,000 downloads reached
\n
\n\n
2009
\n\n
\n\t
Publishing milestone: the first 100 Open Access STM books are published
\n
\n\n
2010
\n\n
\n\t
Downloads milestone: one million downloads reached
\n\t
IntechOpen expands its book publishing into a new field: medicine.
\n
\n\n
2011
\n\n
\n\t
Publishing milestone: More than five million downloads reached
\n\t
IntechOpen publishes 1996 Nobel Prize in Chemistry winner Harold W. Kroto’s “Strategies to Successfully Cross-Link Carbon Nanotubes”. Find it here.
\n\t
IntechOpen and TBI collaborate on a project to explore the changing needs of researchers and the evolving ways that they discover, publish and exchange information. The result is the survey “Author Attitudes Towards Open Access Publishing: A Market Research Program”.
\n\t
IntechOpen hosts SHOW - Share Open Access Worldwide; a series of lectures, debates, round-tables and events to bring people together in discussion of open source principles, intellectual property, content licensing innovations, remixed and shared culture and free knowledge.
\n
\n\n
2012
\n\n
\n\t
Publishing milestone: 10 million downloads reached
\n\t
IntechOpen holds Interact2012, a free series of workshops held by figureheads of the scientific community including Professor Hiroshi Ishiguro, director of the Intelligent Robotics Laboratory, who took the audience through some of the most impressive human-robot interactions observed in his lab.
\n
\n\n
2013
\n\n
\n\t
IntechOpen joins the Committee on Publication Ethics (COPE) as part of a commitment to guaranteeing the highest standards of publishing.
\n
\n\n
2014
\n\n
\n\t
IntechOpen turns 10, with more than 30 million downloads to date.
\n\t
IntechOpen appoints its first Regional Representatives - members of the team situated around the world dedicated to increasing the visibility of our authors’ published work within their local scientific communities.
\n
\n\n
2015
\n\n
\n\t
Downloads milestone: More than 70 million downloads reached, more than doubling since the previous year.
\n\t
Publishing milestone: IntechOpen publishes its 2,500th book and 40,000th Open Access chapter, reaching 20,000 citations in Thomson Reuters ISI Web of Science.
\n\t
40 IntechOpen authors are included in the top one per cent of the world’s most-cited researchers.
\n\t
Thomson Reuters’ ISI Web of Science Book Citation Index begins indexing IntechOpen’s books in its database.
\n
\n\n
2016
\n\n
\n\t
IntechOpen is identified as a world leader in Simba Information’s Open Access Book Publishing 2016-2020 report and forecast. IntechOpen came in as the world’s largest Open Access book publisher by title count.
\n
\n\n
2017
\n\n
\n\t
Downloads milestone: IntechOpen reaches more than 100 million downloads
\n\t
Publishing milestone: IntechOpen publishes its 3,000th Open Access book, making it the largest Open Access book collection in the world
\n
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