The keratoconus treatment toolbox.
\\n\\n
More than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\\n\\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\\n\\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\\n\\nAdditionally, each book published by IntechOpen contains original content and research findings.
\\n\\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\\n\\n\\n\\n
\\n"}]',published:!0,mainMedia:null},components:[{type:"htmlEditorComponent",content:'
Simba Information has released its Open Access Book Publishing 2020 - 2024 report and has again identified IntechOpen as the world’s largest Open Access book publisher by title count.
\n\nSimba Information is a leading provider for market intelligence and forecasts in the media and publishing industry. The report, published every year, provides an overview and financial outlook for the global professional e-book publishing market.
\n\nIntechOpen, De Gruyter, and Frontiers are the largest OA book publishers by title count, with IntechOpen coming in at first place with 5,101 OA books published, a good 1,782 titles ahead of the nearest competitor.
\n\nSince the first Open Access Book Publishing report published in 2016, IntechOpen has held the top stop each year.
\n\n\n\nMore than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\n\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\n\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\n\nAdditionally, each book published by IntechOpen contains original content and research findings.
\n\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\n\n\n\n
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19th 2018",book:{id:"8874",title:"Emergency Operation Technologies for Sudden Water Pollution Accidents in the Middle Route of South-to-North Water Diversion Project",subtitle:null,fullTitle:"Emergency Operation Technologies for Sudden Water Pollution Accidents in the Middle Route of South-to-North Water Diversion Project",slug:"emergency-operation-technologies-for-sudden-water-pollution-accidents-in-the-middle-route-of-south-to-north-water-diversion-project",publishedDate:"December 19th 2018",bookSignature:"Xiaohui Lei",coverURL:"https://cdn.intechopen.com/books/images_new/8874.jpg",licenceType:"CC BY-NC 4.0",editedByType:"Edited by",editors:[{id:"282118",title:"Dr.",name:"Xiaohui",middleName:null,surname:"Lei",slug:"xiaohui-lei",fullName:"Xiaohui Lei"}],productType:{id:"4",title:"Compact",chapterContentType:"compact",authoredCaption:"Authored by"}},authors:[{id:"280923",title:"Dr.",name:"Lingzhong",middleName:null,surname:"Kong",fullName:"Lingzhong Kong",slug:"lingzhong-kong",email:"lzkong@126.com",position:null,institution:null}]},book:{id:"8874",title:"Emergency Operation Technologies for Sudden Water Pollution Accidents in the Middle Route of South-to-North Water Diversion Project",subtitle:null,fullTitle:"Emergency Operation Technologies for Sudden Water Pollution Accidents in the Middle Route of South-to-North Water Diversion Project",slug:"emergency-operation-technologies-for-sudden-water-pollution-accidents-in-the-middle-route-of-south-to-north-water-diversion-project",publishedDate:"December 19th 2018",bookSignature:"Xiaohui Lei",coverURL:"https://cdn.intechopen.com/books/images_new/8874.jpg",licenceType:"CC BY-NC 4.0",editedByType:"Edited by",editors:[{id:"282118",title:"Dr.",name:"Xiaohui",middleName:null,surname:"Lei",slug:"xiaohui-lei",fullName:"Xiaohui Lei"}],productType:{id:"4",title:"Compact",chapterContentType:"compact",authoredCaption:"Authored by"}}},ofsBook:{item:{type:"book",id:"9589",leadTitle:null,title:"Depigmentation as a Disease or Therapeutic Goal",subtitle:null,reviewType:"peer-reviewed",abstract:"
\r\n\tDepigmentation disorders may be congenital or acquired. Congenital diseases of depigmentation include oculocutaneous albinism, piebaldism, Waardenburg syndrome, tuberous sclerosis, nevus depigmentosus and cutaneous mosaicism. Acquired diseases of depigmentation include vitiligo, hypomelanosis secondary to cutaneous inflammation, infectious hypomelanosis, chemical or pharmacologic hypomelanosis, hypomelanosis from physical agents, and miscellaneous. Vitiligo is a very common acquired depigmentation disorder where melanocytes that produce melanin pigment of the skin are destroyed. It can occur systematically and affect whole body or locally/segmentally affecting parts of the body. For the treatment of vitiligo, various medical, surgical and photo therapies are in use, and several emerging new treatments are under investigation.
\r\n\r\n\tThese disorders can profoundly affect patient's quality of life. To improve facial blemishes, many people resort to laser treatments, chemical peels and cosmetics, thus markets for depigmenting lasers and cosmeceuticals are also increasing rapidly. This book aims to cover topics in diseases of depigmentation and therapeutic depigmentation.
",isbn:"978-1-83969-012-9",printIsbn:"978-1-83969-011-2",pdfIsbn:"978-1-83969-013-6",doi:null,price:0,priceEur:0,priceUsd:0,slug:null,numberOfPages:0,isOpenForSubmission:!0,hash:"3e1efdb1fc8c403c402da09b242496c6",bookSignature:"Dr. Tae-Heung Kim",publishedDate:null,coverURL:"https://cdn.intechopen.com/books/images_new/9589.jpg",keywords:"Congenital Depigmentation, Albinism, Piebaldism, Dyschromatosis Hereditaria, Vitiligo, Pathogenesis, Phototherapy, Excimer Laser, Excimer Light, Surgical Treatments, Postinflammatory Hypopigmentation, Pityriasis Alba",numberOfDownloads:null,numberOfWosCitations:0,numberOfCrossrefCitations:null,numberOfDimensionsCitations:null,numberOfTotalCitations:null,isAvailableForWebshopOrdering:!0,dateEndFirstStepPublish:"October 9th 2020",dateEndSecondStepPublish:"November 23rd 2020",dateEndThirdStepPublish:"January 22nd 2021",dateEndFourthStepPublish:"April 12th 2021",dateEndFifthStepPublish:"June 11th 2021",remainingDaysToSecondStep:"2 months",secondStepPassed:!0,currentStepOfPublishingProcess:4,editedByType:null,kuFlag:!1,biosketch:"Dr. Kim graduated from and acquired a doctoral degree (Ph.D.) at Seoul National University College of Medicine. He is an active member of many international and domestic societies and a former President of the Korean Society for Vitiligo.",coeditorOneBiosketch:null,coeditorTwoBiosketch:null,coeditorThreeBiosketch:null,coeditorFourBiosketch:null,coeditorFiveBiosketch:null,editors:[{id:"121353",title:"Dr.",name:"Tae-Heung",middleName:null,surname:"Kim",slug:"tae-heung-kim",fullName:"Tae-Heung Kim",profilePictureURL:"https://mts.intechopen.com/storage/users/121353/images/system/121353.png",biography:"Dr. Tae-Heung Kim graduated from and acquired a doctoral degree (PhD) at Seoul National University College of Medicine. He completed an internship and dermatology residency at Seoul National University Hospital.\r\nHe moved to the Department of Dermatology, Gyeongsang National University, and was then promoted to Professor and Chairman of Dermatology.\r\nIn 1996, he did a research sabbatical for two years at the Department of Immunology, University of Texas MD Anderson Cancer Center.\r\nIn 2003, he started private practice as Director of the White-Line Skin Clinic and Research Center, Changwon, Kyungnam.\r\nHe is an active member of many international and domestic societies, and was the President of the Korean Society for Vitiligo (2016–2018).",institutionString:"White-Line Skin Clinic & Research Center",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"2",totalChapterViews:"0",totalEditedBooks:"1",institution:null}],coeditorOne:null,coeditorTwo:null,coeditorThree:null,coeditorFour:null,coeditorFive:null,topics:[{id:"16",title:"Medicine",slug:"medicine"}],chapters:null,productType:{id:"1",title:"Edited Volume",chapterContentType:"chapter",authoredCaption:"Edited by"},personalPublishingAssistant:{id:"184402",firstName:"Romina",lastName:"Rovan",middleName:null,title:"Ms.",imageUrl:"https://mts.intechopen.com/storage/users/184402/images/4747_n.jpg",email:"romina.r@intechopen.com",biography:"As an Author Service Manager my responsibilities include monitoring and facilitating all publishing activities for authors and editors. From chapter submission and review, to approval and revision, copyediting and design, until final publication, I work closely with authors and editors to ensure a simple and easy publishing process. I maintain constant and effective communication with authors, editors and reviewers, which allows for a level of personal support that enables contributors to fully commit and concentrate on the chapters they are writing, editing, or reviewing. I assist authors in the preparation of their full chapter submissions and track important deadlines and ensure they are met. I help to coordinate internal processes such as linguistic review, and monitor the technical aspects of the process. As an ASM I am also involved in the acquisition of editors. Whether that be identifying an exceptional author and proposing an editorship collaboration, or contacting researchers who would like the opportunity to work with IntechOpen, I establish and help manage author and editor acquisition and contact."}},relatedBooks:[{type:"book",id:"7145",title:"Depigmentation",subtitle:null,isOpenForSubmission:!1,hash:"a17d6aad0e8ef52b617569b590d1443a",slug:"depigmentation",bookSignature:"Tae-Heung Kim",coverURL:"https://cdn.intechopen.com/books/images_new/7145.jpg",editedByType:"Edited by",editors:[{id:"121353",title:"Dr.",name:"Tae-Heung",surname:"Kim",slug:"tae-heung-kim",fullName:"Tae-Heung Kim"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"6550",title:"Cohort Studies in Health Sciences",subtitle:null,isOpenForSubmission:!1,hash:"01df5aba4fff1a84b37a2fdafa809660",slug:"cohort-studies-in-health-sciences",bookSignature:"R. 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Venkateswarlu",coverURL:"https://cdn.intechopen.com/books/images_new/371.jpg",editedByType:"Edited by",editors:[{id:"58592",title:"Dr.",name:"Arun",surname:"Shanker",slug:"arun-shanker",fullName:"Arun Shanker"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"878",title:"Phytochemicals",subtitle:"A Global Perspective of Their Role in Nutrition and Health",isOpenForSubmission:!1,hash:"ec77671f63975ef2d16192897deb6835",slug:"phytochemicals-a-global-perspective-of-their-role-in-nutrition-and-health",bookSignature:"Venketeshwer Rao",coverURL:"https://cdn.intechopen.com/books/images_new/878.jpg",editedByType:"Edited by",editors:[{id:"82663",title:"Dr.",name:"Venketeshwer",surname:"Rao",slug:"venketeshwer-rao",fullName:"Venketeshwer Rao"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}}]},chapter:{item:{type:"chapter",id:"41895",title:"Saphenous Vein Conduit in Coronary Artery Bypass Surgery — Patency Rates and Proposed Mechanisms for Failure",doi:"10.5772/55098",slug:"saphenous-vein-conduit-in-coronary-artery-bypass-surgery-patency-rates-and-proposed-mechanisms-for-f",body:'Coronary artery disease is the single leading cause of death in the United States. Every year more than 1 million open coronary revascularization procedures are performed in the United States. Most commonly the greater saphenous veins and internal mammary and/or radial arteries are used as bypass conduits. Long term patency and avoiding repeat revascularization is every surgeon’s goal following coronary artery bypass grafting. Unfortunately it is estimated that during the first year after surgery; between 10 - 15% of venous grafts occlude. The graft attrition rate is estimated to be 1 - 2 % per year during the first five years following surgery. By 10 years only 50 % of vein grafts remain free from significant stenosis [1].
The reasons for premature graft closure include; biologic, conduit quality, unsatisfactory harvest/preparation, and inappropriate operative strategy or poor surgical technique [2]. Many of these factors can be avoided with proper technique and experience of the surgical team. Currently much of the research being performed on graft failure is leading to the hypothesis of early thrombosis and neointimal hyperplasia as the physiologic basis for graft failure, although the exact mechanism is not well established.
This chapter will discuss current knowledge and ongoing research regarding the thrombosis, intimal hyperplasia and atherosclerosis of vein grafts. It will highlight harvesting techniques and preservation methods, as well as discuss proposed mechanisms that lead to intimal hyperplasia, graft atherosclerosis, and the evolving strategies and current research for long-term prevention of graft failure.
Dr. Rene Favaloro developed the first saphenous vein harvesting technique in 1967 [2]. This technique required a longitudinal incision along the length of the greater saphenous vein entering the fascial canal surrounding the vein and thus causing inadvertent damage to the adventitial layer. Following vein isolation from the surrounding tissues, ligation of side branches, as well as a transection of the vein for completion of the harvest is performed. Since that original description, many methods have evolved from Dr. Favaloro’s original technique. As well, research has focused on the best method of harvesting grafts without damage. In addition to Favaloro’s original technique, current and popular harvesting techniques included; “no touch”, stab phlebectomy, and most recently endoscopic techniques. It is inherit that manipulation of the vein conduit causes damage to the vein itself, but the extent was unknown. Multiple studies have been done to compare; “open”, “no touch”, and “endoscopic vessel harvesting (EVH)” techniques [3]. The traditional open technique which is performed under direct visualization of the vein was found to preserve the endothelium of the vein quite well, but also came with the complications of leg pain i.e. wound healing, post operative cellulitis, and increased length of hospital stay [4], [5]. Initial studies performed on the long-term outcome of vein grafts harvested using the open technique did show that the vein was often stripped of the beneficial adventitial layer as well as distended to high pressures to overcome the associated vasospasm [6]. Unfortunately, the increased distention pressures caused shear stress damage to the vein intima and subsequent endothelial wall [7]. When viewed histologically the endothelial cells appeared deformed, flattened, polymorphic, and contained an abundance of cytoplasmic vesicles [8]. As a method to avoid over-handling of the vein and increased distention pressures a pedicle technique was developed and named the “no touch” technique. It was thought that veins procured in this manner would eliminate the need for conduit distention and its associated morbidities since the perivascular adipose tissue surrounding the vein was left intact [9]. It had been shown that this surrounding tissue in internal thoracic mammary arteries provided a vasodilatory effect with less arterial conduit vasospasm. Increased patency rates were demonstrated with the “no touch” technique compared to the conventional open technique [9]. 1997 began a new era in coronary artery bypass grafting with the use of EVH to harvest the saphenous vein. Endoscopic harvesting techniques were found to eliminate the need for invasive incisions, and decrease the associated risks that accrued with an open technique. Furthermore veins harvested via an EVH method were hypothesized to be promising for graft patency, since endothelial integrity was maintained following EVH harvest compared to other conventional harvesting techniques. This new technique soon became the standard of care with greater than 70% of saphenous vein conduits being retrieved in this manner [10]. Endoscopic harvesting had lower complication rates including less post-operative pain, and decreased patient length of stay. However, controversy arose about the long-term patency of the vein conduits after coronary artery bypass grafting; depending upon what vein harvest method was used in surgery. It was felt veins harvested using an EVH technique failed more often and earlier than veins harvested in the traditional open technique. Studies performed by Desai et al in 2011, confirmed the relationship between the learning curve of EVH and the patency rates based on beginner and expert level of experience in harvesting vein tissue [11]. It has since been shown that when a novice is performing the procedure the vein is subjected to much more stress from trying to better visualize the vein, and 50% of the veins had discrete areas of injury [11]. It was noted that if a section of vein had more than 4 areas of injury, it had a greater than 50% risk of failure of patency [11]. Early studies, which compared the traditional open harvest method to EVH, were published in the infancy stages of EVH when all harvesters were novices to this new technique. Thus, it is now recognized that this confounding issue may have contributed to the decreased long-term patency that was noted. However, this has changed in the past years with “novice” level practitioners becoming experts. It has recently been found that when procured by expert level harvesters the physical damage to the vein is similar to that of open harvest [12], [13]. Thus, it is hypothesized that EVH and open harvest when performed by an expert will have similar patency rates if all other factors are equal.
Standard procedure in the United States is to distend the saphenous vein graft after procurement prior to myocardial implantation to ensure that all branches are ligated. The majority of the time during harvest, the vein is distended to supra-physiologic pressures [14]. While saphenous veins in vivo are rarely subjected to pressures greater than 60 mmHg, recorded pressure measurements during harvest easily reach 300-400 mmHg [15]. This supra-physiologic pressure severely damages the endothelium and ultimately leads to premature graft closure. This high pressure is inadvertently used to overcome vasospasm as well as to ensure ligation of all side branches [16]. The pressure causes shear wall stress that denudes the protective endothelial layer (Figure 1). As a mechanism to protect itself, the endothelium releases basic fibroblast growth factors and platelet-derived growth factors [17]. Basic fibroblast growth factor, a heparin-binding polypeptide that is present in the nucleus and cytoplasm of smooth muscle and endothelial cells and in the intracellular matrix, is normally a non-secreted cell product [18]. Platelet derived growth factor is also widely acknowledged in the process of angiogenesis and most specifically in cell migration and proliferation. The release of these 2 mitogens together initiates intimal hyperplasia [17].
The vascular endothelium has many protective functions, and it releases factors that maintain vein graft patency. The endothelium serves as the physical barrier between the blood components and the sub-endothelium, damage to this endothelium by either direct or indirect stress can disrupt this protective environment causing the formation of atheromas and subsequently graft failure. Injury to the endothelium in addition to surgical manipulation also increases the risk for vasospasm, stenosis, and intimal hyperplasia. Studies have shown that many factors can affect the viability of endothelium; these include temperature, distention, and the composition of solution used in vein preparation. Nitric oxide controls vascular tone in addition to causing vasodilatation. Vascular endothelium contains L-arginine which when combined with nitric oxide synthase forms nitric oxide1. The main target of nitric oxide is to stimulate guanylate cyclase and subsequently form guanosine 3 prime 5 prime-cyclic monophosphate (cGMP). The cGMP leads to vasodilatation and inhibition of platelet aggregation [19]. Furthermore, nitric oxide also has been shown to interfere with cell migration, specifically white cells by reducing the adhesion of neutrophils to the endothelial surface. Several cytoprotective properties are conferred through nitric oxide including; scavenging of oxygen free radicals and blocking release of prostaglandin E2 and F2 alpha. These are anti-inflammatory effects, and are quite intricate in detail, but are based on regulation of transcription factors [20], [21]. Nitric oxide also has some cytotoxic effects including decreasing protein synthesis, increasing lipid peroxidation, and decreasing acute phase proteins [22]. Injury to the endothelium directly causes a decrease in nitric oxide release by the endothelial cells and destroys the integrity of the vein. Studies performed by Kown et al. showed that vein grafts treated with L-arginine (nitric oxide is a by-product created when L-arginine is converted to citrulline) can increase levels of nitric oxide and subsequently decrease hyperplasia [23].
Approximately 12% of patients experience thrombosis of saphenous vein grafts within 30 days of surgery [24]. It has been shown that this acute thrombosis is likely a combination of multiple factors including ischemia and hemostasis during coronary procedures which favors thrombogenesis [25]. The ischemic period in which the vein has been harvested but not yet re-implanted into the myocardium, marks the beginning of the cascade to possible thrombosis. Upon re-establishment of blood flow through the vein it has been shown that neutrophils in the oxygenated blood are attracted to the areas of endothelial injury [26]. This ischemia-reperfusion results in a reduction in both basal and stimulated nitric oxide release, yet attenuates the vaso-relaxation responses to the agonist stimulators of endothelial nitric oxide acetylcholine and bradykinin. Together this impairs the release of nitric oxide and down regulates nitric oxide production after an ischemic event.
After the saphenous vein is harvested, the initial injury causes a decrease in nitric oxide due to the traumatic endothelial cell injury from manipulation and distention. Following the ischemic period and after implantation, nitric oxide synthesis will increase due to the reperfusion. Re-implantation causes release of multiple growth factors, and cytokines that cause the migration and proliferation of vascular smooth muscle cells and formation of extracellular matrix into the intimal compartment of the vein graft. Once neutrophils are adherent they initiate further endothelial damage and activation of the coagulation cascade which can lead to thrombosis [1]. The release of nitric oxide at this time can limit neointimal hyperplasia by inhibiting this proliferation and promoting apoptosis [27].
Neointimal hyperplasia is the accumulation of smooth muscle cells and extracellular matrix that occurs in the intimal layer of vein. This thickening leads to a narrowing of the lumen and subsequent stenosis of the vein graft. Neointimal hyperplasia is the most widely accepted reason for graft failure at the present time. Many theories exist as to why this occurs but none have been completely proven. Work is currently being performed evaluating the up regulation of genes or proteins that may cause the phenomenon of intimal hyperplasia [15]. Nearly all vein grafts placed into an arterial system develop some areas of hyperplasia within the first four weeks. This acute hyperplasia can narrow the lumen of the vein conduit by as much as 25%.
Many studies have related extensive endothelial injury to neointimal hyperplasia development. Injury can be in the form of extreme venous distention, denudation of the endothelium itself, and degree of vasospasm overcome during harvest [28]. Intimal growth is stimulated by several factors including platelet derived growth factor, transforming growth factor beta, and epidermal growth factor which cause proliferation and subsequent invasion of the smooth muscle cells into the intimal layer [1]. When veins are injured, basic fibroblast growth factor is released from the endothelial cells and smooth muscle cells. This is a very potent mitogen that causes the increased production of multiple regulatory proteins, kinases, and genes that participate in DNA synthesis [29]. The sequential activation and inactivation of the cyclin dependent regulatory kinases (Cdk) leads the smooth muscle cells through the cell cycle [30]. Each cyclin exhibits a cell cycle phase specific pattern of expression with several cell cycle checkpoints at the G1/S station. At these points the kinases interact with a cyclin, specifically D and E interacting with Cdk 4/6, and 2. To progress the cell into the M phase cyclin B is activated. These Cdk proteins are inhibited by activating Cdk 1. The G1 Cdk is part of the retinoblastoma pocket proteins that when phosphorylated can sequester cell cycle regulatory transcription factors. This phosphorylation by retinoblastoma proteins as well as specific cylcin dependent kinases during late G1 leads to activation and release of genes that participate in DNA synthesis. It is this complex cascade of cellular activities that leads to proliferation of smooth muscle cells causing neointimal hyperplasia1, [30]. Further research has shown that other theories also exist as to the mechanism of neointimal hyperplasia that includes a role for perivascular fibroblasts and matrix metalloproteinases (MMP’s). It is thought that fibroblasts invade through the media of the saphenous vein graft and differentiate into myofibroblasts. MMP’s are the mediators of matrix deposition and degradation, which can cause neointimal hyperplasia. Theories exist that a strategy to avoid hyperplasia would be to use MMP inhibitors. MMPs compose a super family of 66 known zinc peptidases that degrade collagen, gelatin, and elastin31. MMPs are critical for cell growth and proliferation, cell migration, organ development, reproduction, and tissue remodeling. In all of these biological phenomena, matrix degradation is needed to facilitate changes in cell phenotype. For example, ligand-dependent cell-matrix associations are critical for modulating cell function, and matrix degradation. These interactions can thereby modulate responses of the cell to its microenvironment within the saphenous vein.
Vascular smooth muscle cells, monocytes/macrophages, and endothelial cells have all been shown to express MMPs. Vein graft stenosis appears to be associated with increased expression of MMP-9 and increased activation of MMP-2 [32]. Pharmacological inhibitor studies demonstrate that MMPs are, indeed, involved in the formation of the neointima. Therefore, with this data it appears that MMPs are critical for smooth muscle cell migration and proliferation, which serve as the cellular basis for neointimal proliferation in vivo. Tissue inhibitors of metalloprotienases (TIMPs) are four naturally occurring proteins that inactive MMP’s by binding to them. Kranzhofer et al showed that three of these TIMPs are found on saphenous vein grafts [33]. Several regulatory mechanisms exist to keep a precise balance between enzymes that degrade matrix and proteins that inhibit their action. Cytokines and growth factors, specifically platelet derived growth factor BB act together through a protein kinase C dependent mechanism to increase the expression of MMP-9, whereas transforming growth factor-beta and platelet derived growth factor BB induce TIMP-3 expression in vascular smooth muscle cells [31]. However, they do not have any influence on TIMP-1, or TIMP-2 expression. Baker et al. transfected grafts with a gene for TIMP-3 and observed an 84% reduction in neointima at 14 days and 58% reduction at 28 days in porcine vein grafts [34]. This shows promise for a potential preventative treatment of neointimal hyperplasia, but problems such as weakening of pre-existing atherosclerotic plaques need to be addressed and the longer-term benefits of this therapy remain unknown.
Studies have shown that patients who present with unstable angina after revascularization by previous bypass procedures do so because of an obstructive atherosclerotic lesion in the saphenous vein conduit, and graft stenosis. These plaques have been seen as early as 1 year after bypass procedures [35]. When the vein conduit plaque is viewed histologically, it is found to have an increased number of foam cells than in arterial atheromatous plaques. Recent studies support the theory that a stimulus must exist that induces the expression of inflammatory mediators and may be the inciting factor leading to intimal hyperplasia and eventual graft failure [15].
Scavenger receptor proteins play a vital early role in vascular inflammation. Scavenger receptor proteins on the surface of vascular endothelial cells and macrophage have been shown to upregulate NF-kappaB inflammatory pathways. Studies focusing on upregulation of inflammatory markers following distention compared to non distended vein segments have shown that expression of scavenger receptor-A, scavenger receptor- B, and CD36 are upregulated in the distended saphenous vein tissue [15]. This suggests that the process of distention is an inciting event that allows for the upregulation of scavenger receptors, leading to graft failure through atherosclerotic lesion progression initiated by the formation of foam cells in these saphenous vein grafts.
Pressure distention of saphenous vein conduits has been part of the standard vein preparation procedure for decades. The longer the vein is exposed to pressure distention the higher the expression of biomarkers. These biomarkers include; toll like receptors (TLRs), intracellular adhesion molecules (ICAM), vascular cell adhesion molecule-1 (VCAM-1), and platelet endothelial cell adhesion molecule-1 (PECAM-1). An upregulation of ICAM, VCAM-1, and PECAM-1 was seen in veins that had undergone distention when compared with the nondistended vein [15]. The expression of these cell adhesion molecules is important because an interaction of VCAM-1 and ICAM-1 with monocytes facilitates the monocytes’ recruitment to the vein [36]. Additionally, interactions of ICAM-1 and VCAM-1 with PECAM-1 mediate the process of diapedesis of the monocytes into the vessel wall. These initial cell-mediated events facilitate recruitment of more inflammatory cytokines to the area of injury caused by the damage from distention. PECAM-1 is constitutively expressed on all endothelium regardless of cytokine activation.
Toll-like receptors play a very important role in the signaling pathway of inflammation. Traditionally, TLR4 costimulates with CD14 in chronic conditions. Interestingly TLR4 has also been shown to bind directly to lipopolysaccharide without CD14 costimulation, leading to subsequent NF-kappa B activation. Studies in TLR4-deficient mice have shown that despite the presence of lipopolysaccharide, these mice do not develop neointima, suggesting that neointimal hyperplasia is a TLR4-dependent process [15], [37]. TLR4 in cooperation with interleukin-1 receptor plays a significant role in the formation of neointima. TLR4 signaling also promotes a proinflammatory phenotype and plays a role in the early response to vascular injury. Therefore, the upregulation of TLR4 may play a role in the development of graft failure in terms of neointimal hyperplasia. TLR2 activation with MYD88 leads to cytokine production through NF-kappa B pathways. Thus, these data suggest that vein graft failure is likely a multifactorial process that includes neointimal hyperplasia and inflammation. Immediate vein graft failure is most probably due to inflammatory cytokines whereas late failure (1 year after CABG) is due to neointimal hyperplasia. However, the common cause of both of these processes is quite possibly exacerbated by SV pressure distention [15].
Much interest in reducing neointimal hyperplasia by blocking gene expression is arising. The cell cycle of endothelial cells is now better understood and therefore has allowed for genetics to help play a role in preventing stenosis, thrombosis, and ischemia. If the genetic pathways that are associated with the above process can be fully identified this may ultimately influence coronary graft patency. Ex-vivo work has been promising to show that blocking of the cell cycle via gene therapy has slowed down the atherosclerosis that can lead to graft failure [1].
Repeat coronary vascular procedures will continue to be problematic until an understanding of the mechanisms of vein graft have been elucidated. Thus far, extensive research has been done on this topic, but an overall consensus exists that the saphenous vein is a very fragile and easily injured conduit. Great care must be taken while handling the vein during harvest and preparation to avoid damage or stress to either the external or internal surface of the vein. Avoiding supra-physiologic pressure, prolonged distention periods and manipulations which result in tissue inflammation and injury should be employed to prevent graft failure. Such efforts are expected to reduce the morbidity associated with saphenous vein graft disease and repeat coronary artery bypass interventions.
Scanning electron microscopy photomicrographs of vein tissue following harvest and distention. Saphenous veins underwent endoscopic harvest during bypass grafting procedures with routine pressure distention to ligate side branches. Vein distention was performed by attaching a syringe to the most anatomically distal portion of the vein. A segment of vein was obtained prior to distention and several segments along the length of the vein were harvested after distention and subjected to scanning electron microscopy. Pictures shown in the figure are (A) non-distended vein (B) most distal portion of vein from origin of distention (C) mid section of saphenous vein graft (D) vein segment closest to the syringe. Shown in the pictures are endothelial layer starting to change from a smooth flat surface to a rounded up rough surface.
Keratoconus is a bilateral, asymmetric, progressive ectatic disease of the cornea characterized by progressive corneal thinning which can lead to visual impairment and blindness as corneal protrusion progresses, irregular astigmatism increases and corneal scar occurs [1]. Keratoconus is often under the radar because of decreased awareness, underdiagnosis and undertreatment. The exact pathological mechanism remains unknown, but both genetic and environmental factors may contribute to development and progression of this disease [2]. The reported evidences of pathogenesis of keratoconus include histochemistry, biomechanics, enzymology, proteomics, and molecular genetics [2]. The disease process starts with fragmentation of the epithelial basement membrane, fibrillation of Bowman’s membrane and anterior stroma [3]. Bowman’s membrane breakage occurs later together with epithelial abnormality resulting in proteolytic enzymes release that weakens corneal stromal collagen and stromal thinning [3]. The reported prevalence of keratoconus varies between countries and ethnicities, in which Asian is higher than Caucasian about 4.4 to 7.5 times [4, 5]. The prevalence is ranged from 0.3 in 100, 000 to 2300 in 100,000 in Russia and India respectively [6]. However, the prevalence may be higher in tertiary eye care center or refractive surgery center [7]. Keratoconus is more common in men than women, although both gender are affected [5]. The onset of symptoms usually presents during adolescent and may progress until the 30s. Keratoconus is associated with eye rubbing such as in allergic conjunctivitis, floppy eyelid syndrome, obstructive sleep apnea, Down’s syndrome and Leber congenital amaurosis [1, 8, 9, 10]. Genetic predisposition accounts for an increased risk of keratoconus in patient that has a positive family history about 15 to 67 times [11].
Nowadays, there remain many controversies regarding disease definition, diagnosis, and management of keratoconus. Keratoconus is usually a bilateral disease in which the normal contralateral eye is believed to be in the preclinical stage of keratoconus with different terms such as subclinical keratoconus, keratoconus suspect, forme fruste keratoconus [12]. Despite the advancement of the investigations for the diagnosis of keratoconus and subclinical keratoconus, there are no definitive criteria for discriminating subclinical keratoconus from normal cornea currently [13]. The detection of keratoconus and subclinical keratoconus is crucial to prevent ectasia after refractive surgery. Moreover, some treatment modalities such as corneal collagen crosslinking can prevent vision loss in keratoconus if implement in the early stage of the disease [14]. The early stage symptoms may manifest as reduced vision, fluctuation of vision, progressive myopia and astigmatism, increasing higher order aberrations [4, 15]. When the disease progresses into an advance stage, there is a severe visual loss from high myopia, irregular astigmatism and corneal scarring.
The following criteria are mandatory to diagnose keratoconus- abnormal posterior elevation, abnormal corneal thickness distribution and clinical noninflammatory corneal thinning [10]. However, there is no clinically adequate classification system for keratoconus currently. One of the most popular grading systems is Amsler-Krumeich classification system which classified severity of diseases based on the amount of myopia and astigmatism, corneal thickness or scarring and central keratometry readings [16, 17]. However, Amsler-Krumeich classification system is considered as outdated because it relies on “old” indices (corneal steepness, refractive change, the presence of scarring), and fails to address disease impact [18]. Nowadays, other alternate classification systems are growing in number such as Shabayek-Alio system which is based on corneal higher aberrations and the keratoconus severity score (KSS) which considers average corneal power and root mean square (RMS) [19, 20]. The “ABCD grading system” that incorporates anterior and posterior corneal curvature, thinnest pachymetric values based on the thinnest point and distant visual acuity may better reflects the anatomical change than some previous classification that uses pachymetric value based on apical measurement [21]. In routine clinical practice, the term “advanced keratoconus” usually apply to any case with unacceptably poor spectacle distance vision and contact lens intolerance [18].
The keratoconus diagnosis is bases on the history and clinical examination. However, the investigations are very useful to augment the clinical examination and detect the early stage of disease. Moreover, the accurate diagnosis and early detection of keratoconus in essential in this era which laser refractive surgery has increased markedly. Failure to detect keratoconus and subclinical keratoconus can lead to ectasia after refractive surgery [22]. Corneal topography is the primary diagnostic tool for keratoconus detection. However, corneal topography is not a faultless method and therefore other diagnostic tools such as corneal pachymetry to characterize the corneal thinning and aberrometry to characterize degradation of the corneal optics should be used as complimentary techniques [22]. Corneal tomography which based on rotating Scheimpflug camera, such as Pentacam, Galilei, or Sirius systems, provide the topographic, pachymetric, and aberrometric information simultaneously as their use is adequate enough for the keratoconus detection [12, 22]. Currently, OCT technology is being used to differentiate between eye with keratoconus and normal eye because it can provide accurate pachymetric characterization, define epithelial thickness irregularity and asymmetry that present in keratoconus [7, 23]. By analyzing the biomechanical properties of the cornea that may precede the anatomical change, the Ocular Response Analyzer and Corvis systems can provide good diagnostic accuracy [22]. Analysis of the Corneal Microstructure change in keratoconic eye from confocal microscopy such as reducing corneal nerve fiber density and nerve fiber length, reducing keratocyte density, increasing corneal stromal nerve thickness, may be useful in detecting structural changes occurring before manifestation of topographic signs [22, 24]. A combination of multiple imaging modalities, including corneal topography, corneal tomography, Scheimpflug imaging, anterior segment optical coherence tomography, and in vivo confocal microscopy will enhance early keratoconus detection. Modalities during investigations but show promise include polarization-sensitive optical coherence tomography, Brillouin microscopy, and atomic force microscopy [25].
Keratoconus progression detection is a critical issue because the treatment nomograms have been proposed based on the grading system and ectasia progression [15, 22]. Moreover, the disease progression is differed considerably among individual. The younger the patients are, the higher their risk for rapid progression [26]. Currently, there is no global consensus of ectasia progression. The Group of Panelists for the Global Delphi Panel of Keratoconus and Ectatic Diseases had defined the definition of “ectasia progression” as a consistent change overtime in at least 2 of the following parameters where the magnitude of the change is above the normal noise of the testing system:
Steepening of the anterior corneal surface.
Steepening of the posterior corneal surface.
Thinning and/or an increase in the rate of corneal thickness change from the periphery to the thinnest point” [10].
Various clinical studies have used different parameters to define disease progression. The most important parameters include: [27, 28]
An increase in maximum corneal refractive power (Kmax) by more than 1 diopter (D) within 1 year
An increase in (corneal) myopia by more than 3 D or astigmatism by more than 1.5 D within 12 months
An increase in mean corneal refractive power by more than 1.5 D within 12 months
A reduction in minimal corneal thickness of more than 5% within 12 months.
The regular topographic/tomographic check-ups can identify keratoconus progression. Regarding the examination intervals, the individual risk profiles need to be taken into consideration. The risk factors that should be considered include eye rubbing, ocular allergies, young age, steep corneal curvature gradient, high astigmatism, marked visual loss, documented progression in the fellow eye, atopic dermatitis or Down’s syndrome [28]. In children, keratoconus tends to be more severe and progress faster requiring closer follow-up intervals [26]. The patient with low risks can be monitored less frequently than the one with high risks. Keratoconus progression is often associated with a decrease in best spectacle-corrected visual acuity (BSCVA), however, a change in both uncorrected visual acuity and BSCVA is not required to document progression [10].
The important goals of keratoconus management are stopping disease progression and visual rehabilitation [10]. In cases of ocular allergies, patients should be treated with topical antiallergy and lubricants and should be instructed to avoid eye rubbing to halt disease progression. Corneal collagen crosslinking is a promising procedure to stop disease progression with minimal side effects [29]. For the visual rehabilitation, several treatment options corresponding to keratoconus grading have been established. Keratoconus can be treated by both nonsurgical and surgical approaches depend on severity and progression of the disease [15]. The keratoconus treatment toolbox is listed as in Table 1.
A nonsurgical treatment of keratoconus is spectacles and contact lens. For early stage of disease, those who achieve visual acuity 20/40 or better, spectacles can provide acceptable vision [15]. A toric soft contact lens also provides satisfactory vision for correcting myopia and regular astigmatism in early keratoconus. However, as the diseases progress, spectacles or soft contact lens may not provide acceptable vision because of the higher- order aberrations, in particular vertical coma was increased [30]. Therefore, other special lens such as rigid gas permeable (RGP) contact lens, hybrid lenses, piggy back, miniscleral lens, semiscleral lens or scleral lenses are needed to provide satisfactory vision [31]. The ultimate goal of fitting contact lens in keratoconus is to improve visual acuity without compromise ocular health. However, contact lens use does not slow or stop progression of the disease. In keratoconus, the cone is steeper but the cornea beyond the cone is flatter. In mild keratoconus, traditional RGP lens can provide an ideal fit. However, as the disease progress into advanced stages, it becomes difficult to achieve an ideal fit but compromised fit which is not damage to the ocular surface is acceptable. High oxygen transmissibility lens should be selected to prevent hypoxic-related corneal changes [31].
The type of contact lens selection is based on manifest refraction, degree of keratoconus, and morphology of the cone [31]. Corneal topography can aid in addressing the severity and morphology of the cone. Buxton et al. have classified keratoconus based on keratometry values (K) at the apex of the cone: mild if K is less than 45 D, moderate if K is between 45 and 52 D, advanced if K is more than 52 D and severe if K is more than 62 D [32]. The morphology of the cone is classifed as the following [33].
nipple cone: small, paracentral, steeper located inferiorly or inferonasally
oval cone: inferiorly or inferotemporally steeper cornea
globus cone: overall steeper cornea, involves more than three forth of the cornea up to limbus
The three essential parameters in contact lens fitting are power, diameter, and base curve of contact lens.
Power: Low minus for mild keratoconus, high minus for severe keratoconus
Base curve: Flatter base curve for mild keratoconus, steeper base curve for severe keratoconus
Diameter: Based on the cone location, its size and steepness, nipple has a small diameter, usually start with a small diameter such as 8.7 mm, oval cone needs larger diameter lens, globus cone or severe apical displacement need large diameter contact lens.
A contact lens type is selected based on the manifest refraction and the degree of keratoconus. The contact lens of choice for keratoconus patients is RGP lens. However, if the patients develop intolerance or discomfort, customized soft toric contact lens, PBCL, hybrid lens or scleral lens can be considered. The indications, advantages and disadvantages of each contact lens type are summarized as in Table 2 [30, 31, 34]. Fitting contact lens in keratoconus can improve vision and delay the need for keratoplasty. Moreover, contact lens in keratoconus patient also have a role in correcting residual refractive error after Corneal collagen cross-linking (CXL), after Intrastromal corneal ring segments (ICRS) or post-keratoplasty [31].
Nonsurgical treatments | Surgical treatments |
---|---|
|
|
The keratoconus treatment toolbox.
RGP = Rigid gas permeable contact lens, IOL = intraocular lenses, PBCL = Piggyback lens, TG-PRK = Topo guided- Photo Refractive Keratectomy.
Contact lens types | Indication | Advantages | Disadvantages |
---|---|---|---|
Soft/ Soft toric |
|
|
|
RGP |
|
|
|
Hybrid lens |
| Comfort |
|
Piggyback lens (PBCL) |
| Comfort |
|
Scleral lens |
|
|
|
Contact lens in keratoconus (KC).
RGP = Rigid gas permeable, Hybrid lens = rigid lens in the center and a soft skirt in the periphery, PBCL = Piggy back lens (RGP lens sitting on top of a soft contact lens) KC = keratoconus, GPC = giant papillary conjunctivitis, VA = visual acuity.
Even though the specialized imaging device can provide grading scheme of keratoconus, for practical purposes, the term “advanced keratoconus” may apply to any cases that have unacceptably poor spectacle distance vision and contact lens intolerance. As the diseases progress, spectacles or contact lens cannot provide acceptable vision. This group of patients requires a surgical management such as Corneal collagen cross-linking (CXL), Intrastromal corneal ring segments (ICRS), and Corneal transplantation to restore vision and/or stabilize progression of diseases.
The special considerations in surgical management of keratoconus are listed in Table 3.
Keratoconus typically progresses until the fourth decade, when most but not all, slows or stabilizes [35]. Corneal crosslinking (CXL) has been proposed as a new treatment modality to stop progression of keratoconus since the late 1990s [27]. Currently, CXL is the gold standard and only minimally invasive surgical procedure that halt the progression of keratoconus [27]. The indications for CXL are progressive keratoconus in adults and postoperative ectasia, central corneal thickness more than 400 μm, Kmax 58 D or less [35, 36]. However, the procedure is not approved for stable keratoconus currently. CXL is the promising treatment that can prevent progressive visual loss due to disease evolution and delay invasive surgical procedures such as corneal transplantation. The mechanism of cornea strengthening is a photochemical reaction of corneal collagen by the Riboflavin as a photosensitizer in the photopolymerization process and ultraviolet A irradiation (UVA). The interaction between Riboflavin and UVA can increases the formation of intrafibrillar and interfibrillar carbonyl-based collagen covalent bonds [37].
The standard Dresden protocol was proposed as a treatment option for keratoconus by Wollensak et al. in 2003 [36]. This standard technique is conducted under topical anesthesia. The central corneal epithelium is removed followed by application of 0.1% riboflavin solution (0.1% riboflavin in 2o% dextran solution) as a photosensitizer every 5 minutes for 30 minutes. Then the cornea is exposed to 370 nm UVA with an irradiance of 3 mW/cm2 or 5.4 J/cm2, during which time riboflavin solution is re-applied every 5 minutes. After the treatment, topical antibiotics eye drops are applied and bandage contact lens placed upon the eye [36]. Although this standard protocol has been proven to be an effective procedure to halt keratoconus progression [39], it is a time-consuming procedure, may create patient discomfort and has post-operative complications related to corneal abrasion. The reported complications in association with CXL include corneal haze, corneal infection, corneal edema, and corneal melting. Adverse effects are common but mostly transient and of low clinical significance [40]. However, anterior corneal stromal haze is a typical postoperative finding that often occurs in the first month after treatment and typically resolves after 12 to 20 weeks [41]. The posterior aspect of this haze is an indistinct hyperreflective demarcation line seen in the mid stroma that represents the depth of CXL [37]. Two trends have emerged to modify the standard Dresden protocol. The first is a tendency to shorten treatment times [42]. Alternative treatment protocols with different formulations of riboflavin solution and delivery methods by altered UV exposures have been proposed. These newer techniques can shorten duration times, reduce patient discomfort, and minimize postoperative complications. The second trend is “epi-on” approach, such that the epithelium remains intact during CXL. These modifications were described in the following sections.
According to Bunsen- Roscoe law of photochemical reciprocity, which states that “the same photochemical effect can be achieved with a reduced irradiation interval provided the total energy level is kept constant through a corresponding increase in irradiation intensity” [37]. ACXL is a modified CXL technique that increase the intensity of ultraviolet A (UV-A) irradiation and shortening the exposure time without altering the total energy delivered. Currently commercial devices now offer ultrafast settings such as 43 mW/cm2 for 2 minutes [42]. Using this setting, would achieve the standard Dresden protocol energy dose of 3.4 J or a radiant exposure of 5.4 J/cm2 within 2 minutes [42]. However, it ignores the requirement of oxygen in the CXL reaction, the time needed for oxygen replenishment, and potential physical damage due to higher irradiance [35]. The reduced efficacy of ACXL is believed to be due to depletion of oxygen in these high-fluence treatments [43]. The efficacy, safety, and treatment protocols of accelerated CXL are still being investigated and in evolution.
Due to the epithelial debridement is a major contributor to the postoperative complications of CXL, such as infective keratitis and an abnormal wound-healing response [37]. This issue has perpetuated interest in epithelium-on technique. Epi-on CXL has less discomfort to the patient and reduces postoperative complications [43]. This CXL technique has low complication rate, 0% to 3.9% of the patients has only transient haze [37]. According to the hydrophilic property of riboflavin solution, the penetration through the intact hydrophobic corneal epithelium is difficult. The standard formulations show minimal penetration through intact epithelium. The modifications by adding various additives, such as benzalkonium chloride, topical anesthetic, tris(hydroxymethyl) aminomethane (trometamol), sodium ethylenediaminetetraacetic acid, have been proposed to improve epithelial permeability to riboflavin [35]. Riboflavin penetration can be improved by increased riboflavin concentration and iontophoresis [35]. Since even the low amount of riboflavin surface films will markedly block UV-A transmission, transepithelial formulations are often rinsed from epithelial surface before irradiation [35]. The iontophoretic delivery system uses of mild electrical current for delivering riboflavin through the epithelium [35]. It allows greater and deeper riboflavin penetration in the corneal stroma than the conventional epithelium-on technique. Overall, the effectiveness of transepithelial techniques has been disappointing [27]. Epi-on CXL has limited keratocyte apoptosis, shallower demarcation line and less biomechanical rigidity than standard epi-off CXL [37]. In general, better outcomes can be achieved by standard epithelium off technique and epi-on CXL have resulted in progression of the disease after treatment [35, 44]. However, recent research with innovative transepithelial CXL system achieved 4-fold higher corneal stromal concentrations of riboflavin than commercially available epi-on CXL system, and this level is theoretically adequate for effective CXL [44].
Due to the presence of oxygen is required for CXL, but high-exposure doses of UVA light cause a decrease in the oxygen concentration rapidly [45]. The recent technique has focused on pulsing the UVA light with “on” and “off” periods to increase the efficacy of CXL treatment by replenishing the consumed oxygen [46]. This technique is an effective treatment modality to stop progression in progressive keratoconus but regresses some of the cases [46].
Despite the fact that CXL can halt the progression of keratoconus and provide corneal stability, functional visual acuity remains a problem [47]. Recent data from the systematic review disclosed that conventional epi-off CXL can flattening cornea 2 D approximately and improving visual acuity 2 lines or 10 letters on average [48]. CXL normalizes the corneal shape by changing the physical properties of the cornea, resulting in reduction of all corneal aberrations, high order and low order. The improvement in uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) are related to improvement in the total corneal aberrations and only high-order aberrations respectively [49].
In order to address this issue, CXL can be performed alone or in combination with topo guided photorefractive keratectomy (PRK), ICRS, phakic IOLS or Topo guided PRK plus ICRS for better improvement of visual acuity [15].
CXL + Topo guided PRK
Kanellopoulos et al. reported the first case of topography-guided PRK performed 1 year after CXL for treatment of keratoconus and showed visual acuity improvement [50]. On the contrary, the Athens protocol which combines accelerated UV-CXL with same-day photorefractive keratectomy (PRK) was more effective with improvement in UDVA and CDVA of 20/45 or better (2.25 logMAR) was founded in 83% of patients at last follow up [51]. However, this study was conducted in post-LASIK ectasia [51]. Same-day simultaneous topography guided PRK CXL in progressive keratoconus appears to be superior to sequential CXL with later PRK (6 months later) in the aspect of UCVA, BSCVA, spherical equivalent (SE) and mean reduction in K [52]. This combined technique also prevents regression of keratoconus and reduce the risk of keratectasia and might be suitable for eyes requiring improvements in irregular astigmatisms but still have good CDVA [47, 53].
CXL + ICRS
The CXL can be performed before, simultaneously or after the ICRS. The advantage of performing the CXL first is slowing the progression of the keratoconus and selects the best alternative way to treat the residual refractive error [54]. The recent systematic review and meta-analysis demonstrated that simultaneous ICRS implantation and CXL may provide better outcomes in term of refraction and keratometry. However, UDVA, BCVA and cylindrical refractive error were similar between combined technique and staged procedure [55]. The combined procedure of CXL plus ICRS implantation appears safe and efficacious for the treatment of progressive keratoconus with significant improvements in visual acuity, keratometry values, and refractive error [54]. This technique might be effective for eyes with more irregular astigmatism and worse CDVA [53].
CXL + Topo guided PRK + phakic IOLS
The simultaneous topography-guided photorefractive keratectomy (PRK) and crosslinking (Athens protocol) followed by phakic intraocular lens (IOL) implantation 2–4 months later for managing keratoconus improved and stabilized visual performance in patients with keratoconus. The Kmean, SE, UDVA, CDVA improved significantly. At last follow-up, all eyes could achieve CDVA of 0.3 or better [56].
CXL + ICRS+ + phakic IOLS
Three steps treatment of keratoconus by ICRS implantation, CXL and phakic IOLS significantly improve UDVA, CDVA, higher order aberrations and corneal shape in moderate to severe keratoconus [57]. Moreover, keratometry (Ksteep, Kflat, Kmax) and refraction (sphere, SE, but not cylinder) were also improved [58]. The time interval between ICRS implantation and CXL was 4–6 weeks and ICL implantation was performed 6–8 months after CXL [57, 58].
The 0.1% riboflavin in 20% dextran solution is used in original Dresden protocol. Only the anterior 300 μm of stroma can be treated [36, 59]. This standard technique requires corneal pachymetry more than 400 μm after de-epithelization to decrease complications such as corneal stromal scar and corneal endothelial cytotoxicity [47, 60]. In order to combat this issue, there are various modifications to the conventional CXL protocol for CXL in thin cornea. These modifications include hypoosmolar riboflavin, transepithelial CXL, iontophoresis-assisted CXL, Customized epithelial debridement technique, Lenticule-assisted CXL, contact-lens- assisted CXL (CACXL) and individualized corneal CXL [60, 61, 62, 63, 64, 65, 66, 67].
Hypoosmolar riboflavin has lower colloidal pressure (310 mOsmol/L vs. 402.7 mOsmol/L in isotonic riboflavin) that causes stromal swelling to double its thickness where stromal bed is less than 400 μm [60]. However, the efficacy of CXL using hypoosmolar riboflavin was lower than traditional CXL with isotonic riboflavin. The possible theory to explain is that in hydrated corneas (using hypoosmolar riboflavin) concentration of collagen fibrils is decreased, hence fewer collagen fibrils are available for CXL [60, 61]. By changing the osmolarity of the riboflavin solution, while maintaining the concentration at 0.1%, probably does not alter the final riboflavin concentration in the cornea. On the contrary, modifying other parameters to obtain a more shallow depth of treatment; ie, the intensity of the UVA light, the duration of treatment, or the intensity of riboflavin concentration will alter the final riboflavin concentration in the cornea and require new dose–response assays [61]. Unfortunately, these modified techniques have not yet distinguished themselves as more effective than any other in terms of topographic or visual outcomes.
Despite the fact that CXL has a promising clinical outcomes, risk factors for ongoing ectasia include the application of isotonic riboflavin solution to thicken a thin cornea prior to treatment, corneas steeper than 58 D and age > 35 years [18, 68]. The most frequent definition of treatment failure is the continual progression of keratoconus with an enhancement of Kmax reading of 1.0 D 0r 1.5 D over the preoperative value [40, 47]. The outcomes of different CXL techniques are listed as in Table 4.
Considerations | Details |
---|---|
Corneal thickness (Corneal thinness) |
|
Kmax |
|
Preoperative BCVA |
|
Endothelial health |
|
Lens status |
|
Patient age (Pediatric) |
|
Ability to cooperate (Mental disability) |
|
Pre-existing corneal scarring (previous hydrops) |
|
Special considerations in surgical management of keratoconus.
currently little to recommend UV-CXL in corneas thinner than 400 μm [18] .
CCT = central corneal thicknesses, Epi-on CXL = Epithelium-0n Corneal collagen cross-linking, ICRS = Intrastromal corneal ring segments, DALK = Deep Anterior Lamellar Keratoplasty, PK = Penetrating keratoplasty, D = diopter, KC = keratoconus, Kmax = Maximal corneal steepness, BCVA = best corrected visual acuity.
Adapted from Surv Ophthalmol. 2015 Sep;60(5):459–80. [18] J Cataract Refract Surg. 2015 Apr;41(4):842–72 [37].
Treatment | Visual outcomes | Refractive outcomes | Topographic outcomes | Disease progression |
---|---|---|---|---|
Standard CXL |
| |||
Epi-on CXL/ Transepithelial CXL |
|
| ||
Accelerated CXL |
| Conflicting findings [88] | ||
Pulsed-Light Accelerated CXL |
| All eyes show stability of Kmax, 30% show small increase in Kmax at 12 months [92] | ||
Intrastromal corneal ring segments (ICRS) |
| Stop progression >90% for mild to moderate KC at 5 and 10 years [68, 93, 94] | ||
Penetrating keratoplasty (PK) | Donor button is
| Approximately 10% of eyes will display recurrent KC 20 years after PK; some diseased recipient cornea is left unremoved [95, 96] | ||
Deep Anterior Lamellar Keratoplasty (DALK) | 2 D steeper than if they had received a similarly sized PK [18] | NA | ||
Bowman layer transplantation |
|
K max 8–9-D [71, 76]
|
|
Outcomes of surgical treatment of keratoconus.
CXL = Corneal collagen cross-linking, PRK = Photorefractive keratectomy, IOL = intraocular lenses, UDVA = Uncorrected Distance visual acuity, CDVA = Corrected Distance visual acuity, BCVA = Best Corrected Visual Acuity, BSCVA = Best Spectacles Corrected visual acuity, D = Diopter, SE = spherical equivalent.
Other than standard CXL, formulation of riboflavin solutions, riboflavin concentration, total UVA energy that was used for each study may be different.
Intrastromal corneal ring segments (ICRS) were FDA-approved in 1999 for the treatment of low myopia. ICRS implantation causes displacement of the collagen fibers resulting in flattening of the central cornea and tissue adjacent to the ring is displaced forward [37]. ICRS are segments of polymethylmethacrylate (PMMA) plastic available in numerous arc-lengths, thicknesses, and designs. Five types of ICRS are available for keratoconus: 1) Intacs (Addition technology Inc.) 2) Intacs SK (Addition technology Inc.), 3) Ferrara Rings (Ferrara ophthalmics) and 4) Keraring (Mediphacos).5). MyoRing (Dioptex, GmbH, Linz, Austria). The devices are inserted into stromal tunnels that may be created manually using a corkscrew blade or femtosecond laser with no difference in results (except that channels tend to be slightly shallower when created manually and more often decentered when created by laser) [37]. The objective of ICRS implantation is to improve visual and topographic outcomes and restoration of contact lens tolerance [15, 18, 37]. Maximal flattening effect occurs with segments at 60–79% corneal thickness. Shallower than 60%, the effect may be lessened and can induced ocular surface complications. On the contrary, deeper than 80%, there may have no topographic effect [69]. The outcome achieved is directly proportional to the thickness of the ICRS and inversely proportional to its diameter [37]. ICRS can be used alone or used in combination with other treatment options such as CXL for stabilizing disease progression [15]. The outcomes of ICRS are listed as in Table 4.
Although, ICRS has good visual and topographic results, some complications have been reported. Intraoperative complications rate are low, but can occur and usually relate to corneal tunnel creation such as insufficient tunnel depth, asymmetry or decentration, or Bowman’s layer perforation [15]. The post-operative complications have been reported such as corneal neovascularization, keratitis, deposits around ring segment, corneal haze, halos, pain, corneal melting or edema, segment extrusion, visual fluctuation, and photophobia [15]. This procedure is reversible and not preclude from further surgeries such as CXL and/or corneal transplantation. Due to complications such as stromal necrosis, segment extrusion of synthetic ICRS material, corneal allogenic ICRS (CAIRS) combined with CXL has been reported. Instead of using PMMA to create segment, CAIRS is trephined from donor cornea. CAIRS were implanted into mid-depth corneal tunnel that was created by femtosecond laser, followed by ACXL [70]. This procedure has a promising result in term of improvement of UDVA by 2.79 lines, CDVA by 1.29 lines. Moreover, this procedure demonstrated improvement of SE, Kmax, Ksteep and topographic astigmatism and halt progression in all cases during follow period [70].
Treatment options for advanced keratoconus that has corneal thickness less than 400 μm, Kmax more than 58 D may be limited to corneal transplantation that can stabilize the cone and enable continued contact lens wear [71]. The keratoplasty techniques may be penetrating keratoplasty (PK), Deep Anterior Lamellar Keratoplasty (DALK) or Bowman layer transplantation.
Penetrating or lamellar keratoplasty techniques are used depending on the extent of corneal scarring [15]. PK provides long term good vision but has slow visual rehabilitation from residual astigmatism and anisometropia [15]. Both PK and DALK tend to worsen any existing ocular surface problems, as both involve surface incisions, injury of corneal nerves, placement of long-lasting sutures, and requiring post-operative topical corticosteroids [18]. Despite the facts that long term graft survival following PK for keratoconus is good, averaging 97% at 5 years, 90% at 10 years and 80% at 20–25 years, most of the patients with advanced KC are transplanted early in life, therefore it is more likely that more than one graft may be required over their lifetime ultimately [18].
The visual outcomes of BCVA, UDVA for DALK remains debated. The recent data from systematic review and meta-analysis demonstrated that the visual outcomes were worse [72] or better [73] than those for PK. The outcomes of DALK for keratoconus are better than PK [73] or equivalent [73] in terms of refractive error, astigmatism and rejection rate. Fifty percent of eyes may encounter Descemet membrane perforation which is the most significant intra-operative complications [18]. Other complications such as a double anterior chamber and persistent corneal edema have been reported. DALK may be less prone to secondary ocular hypertension because of their lower steroid requirement (owing to the smaller risk of rejection) [18]. Another advantage DALK is the lack of endothelial rejection because there is no endothelial defense reaction [15]. The reported rates of postoperative complications such as graft rejection, secondary glaucoma, complicated cataracts, and constant endothelial cell loss are lower with DALK than PK [15].
The PK or DALK may be disrupted by complications such as suture-related problems, graft rejection, epithelial wound-healing abnormalities, corneal curvature changes due to progression of KC in the peripheral host cornea resulting in disappointing visual results [71]. In KC corneas, pathological changes include the reduction of number of keratocytes, organization of the stromal lamellae, fragmentation or absent of Bowman’s layer (BL) [74] It has been suggested that the BL may be the strongest biomechanical element of the human cornea followed by the anterior third of the cornea [75]. Therefore, the BL may play a structural role in maintaining the shape/tectonic stability in KC corneas [76]. This procedure was first described in 2014, Bowman’s layer graft was positioned inside the recipient corneal stroma in a sandwich technique, without corneal incision or sutures, to pull the anterior corneal surface flatter and create homogeneous corneal topography [71]. BL transplantation can be performed under local anesthesia and low dose topical steroid can stop within 1 year post-operative, minimizing the risk of glaucoma development or cataract formation [71, 76, 77]. The reported complications are low such as intraoperative microperforation of the Descemet’s membrane [76, 77]. Because of the transplanted tissue is acellular, no episodes of allograft rejection have been observed [71, 76]. This procedure may postpone penetrating keratoplasty (PK) or deep anterior lamellar keratoplasty (DALK) and potentially allowed long term contact lens wear [71]. Although graft preparation and surgical technique can be challenging, assisted technologies, such as femtosecond laser and intraoperative anterior segment optical coherence tomography (OCT), may help conquer these barriers [78, 79]. “Bowman layer onlay,” a recently developed surgical technique in which an isolated Bowman’s layer graft, is positioned onto the patient’s anatomical Bowman’s layer or anterior stroma, has demonstrated the rapid re-epithelization and integration of the tissue and comparable clinical outcomes to intrastromal transplantation [80]. The outcomes of each keratoplasty techniques are listed in Table 4.
There are a variety of nomograms for the treatment of keratoconus which are mainly focused on the keratoconus grading, risk factors, the progressive nature of the disease, and contact lens tolerance [15]. The management algorithm in various stages of keratoconus is shown in Table 5.
Classification* Disease progression | Management | |||
---|---|---|---|---|
Stage 1 | Stage 2 | Stage 3 | Stage 4 | |
Non- progressive | Spectacles | Spectacles | ||
CL | CL | CL | CL | |
CL intolerance | CL intolerance | |||
ICRS | ICRS | |||
BL transplantation | BL transplantation | |||
DALK/PK | ||||
Progressive | Spectacles | Spectacles | ||
CL | CL | CL | CL | |
CL intolerance | CL intolerance | |||
CXL | CXL | CXL | ||
ICRS | ICRS | |||
BL transplantation | BL transplantation | |||
DALK/PK |
Management algorithm in various stages of keratoconus.
Adapted from JAMA Ophthalmol. 2014 Apr 1;132(4):495–501.
The classification of keratoconus was based on Krumeich JH et al.A. Live-epikeratophakia for keratoconus. J Cataract Refract Surg. 1998 Apr;24(4):456–63. [17]
Stage 1 Kmax < 48 D, thickness > 500 μm, absence of scarring.
Stage 2 Kmax 48–53 D, thickness 400–500 μm, absence of scarring.
Stage 3 Kmax 54–55 D, thickness 200–400 μm, absence of scarring.
Stage 4 Kmax > 55 D, thickness < 200 μm, central corneal scarring.
Treatment for advanced KC has trended away from invasive procedures such as PK and even DALK toward minimally invasive procedures such as CXL, ICRS or BL transplantation. Although keratoconus is a multifactorial disease, the pathogenesis of the disease is very much affected by genetic factors and positive family history [2, 8, 81]. By identifying pathogenic genes and changing the structure of cell proteins, gene therapy may be a very promising and effective treatment modality to change the course of the disease [15].
The two most important goals of management of keratoconus are stopping disease progression and visual rehabilitation. An ocular allergy should be treated. Care providers should instruct the patients to avoid eye rubbing to halt disease progression. A careful follow up is needed to document disease progression and provide prompt treatment. A nonsurgical treatment of keratoconus includes spectacles or contact lens. Contact lens use does not slow or halt progression but can provide satisfactory vision in early stages of keratoconus. A contact lens type is selected based on the manifest refraction and the degree of keratoconus.
The five operations (CXL, ICRS, PK, DALK and BL transplantation) currently represent the available surgical treatment options for advanced KC. Treatment for advanced KC has trended away from invasive procedures such as PK and even DALK toward minimally invasive procedures such as CXL, ICRS or BL transplantation. CXL and ICRS were once regarded only for mild to moderate keratoconus, their roles are now expanding in advanced diseases as well.
PK and DALK provide long term good vision but has slow visual rehabilitation and may be disrupted by complications such as suture-related problems and graft rejection. BL transplantation was introduced for advanced KC with extreme thinning/steepening. This novel procedure may postpone penetrating keratoplasty (PK) or deep anterior lamellar keratoplasty (DALK) and potentially allow long term contact lens wear. Since genetic factors play significant roles in KC, advances in gene therapy may soon yield innovative treatments of this disease.
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