Vision Restoration with a Collagen Crosslinked Boston Keratoprosthesis Unit
Abstract
Objectives and Rationale: The goal of this proposal is to evaluate the safety and efficacy of a new method for preparing and transplanting an artificial cornea (keratoprosthesis) unit by using a novel procedure, known as corneal cross-linking, to reduce the incidence of corneal melts and improve the outcomes of keratoprosthesis surgery. The Boston Keratoprosthesis is used as a last recourse to restore vision to eyes that suffer from corneal blindness, the second most common cause of blindness worldwide. The Boston Keratoprosthesis is the most widely used keratoprosthesis worldwide and is implanted when patients are not candidates for a traditional corneal transplant. Unfortunately, the most common cause of keratoprosthesis failure is due to corneal melts, which can lead to permanent vision loss. We have developed a method to reduce the incidence or potentially eliminate corneal melts by strengthening the keratoprosthesis carrier cornea using tissue that has been cross-linked using vitamin B2 (riboflavin) and ultraviolet light prior to prosthesis assembly. The approach proposed in this application is both feasible and valuable for several reasons: (1) collagen cross-linking has shown significant efficacy in strengthening many different types of tissue, including the cornea, (2) corneal cross-linking has been used internationally in humans for over 10 years with an excellent safety profile, (3) the proposed treatment approach can be used by eye banks to provide cross-linked corneas to keratoprosthesis surgeons at a relatively low additional cost, (4) preventing corneal melts would avoid potentially blinding complications that render many patients as lifelong dependents of government resources, and (5) both benchtop studies and pilot human studies support our approach that uses corneal cross-linked tissue to prevent keratoprosthesis-related corneal melts. Applicability and Military Benefit: There is often a gap between scientific discoveries and patient care. In fact, many of the most recent important scientific discoveries have not been translated from the bench top to clinical care or even studied in a clinical trial. Moreover, translational studies are extremely important if scientific discoveries are going to be used to help patients. As a result of collaborative effort between academia and the Department of Defense, this study represents the next step in translating basic science research into clinical care. While benchtop studies and pilot human clinical studies have suggested that corneal melts can be reduced by collagen cross-linking the carrier cornea for a keratoprosthesis, this study proposes a prospective, randomized, multicenter clinical trial to answer important questions about the safety and efficacy of the procedure. To date, no prospective, multicenter trials have been completed using a keratoprosthesis. Therefore, in addition to providing valuable information on keratoprosthesis surgery and outcomes, this study aims to provide the military and the public with a safer keratoprosthesis treatment for blinding corneal diseases. Due to the changes in survival, munitions, and style of warfare, the proportion of surviving Soldiers with serious anterior segment eye trauma has progressively escalated over the last century. From 2000 to 2010 there were over 186,000 eye injuries to members of the U.S. Armed Forces. According to Department of Veterans Affairs data, eye trauma accounted for 15% of all battlefield injury and was the fourth most common injury during Operation Iraqi Freedom and Operation Enduring Freedom. Importantly, the most common ocular pathology experienced by deployed Warriors involved corneal diseases, which can result in scarring and, in severe cases, the need for corneal transplantation. Unfortunately, corneal transplants remain under constant risk of rejection and approximately 30% of corneal grafts in the United States are at risk of rejection annually. In eyes that would ha
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 29, 2016
- Source ID
- W81XWH1520044
Entities
People
- Joseph B Ciolino
Organizations
- Massachusetts Eye and Ear Infirmary
- United States Army