Of the 1.4 million refractive surgeries performed each year using laser assisted in situ keratomileusis (LASIK) in the U.S., 1 in 2500 will result in post-LASIK ectasia-a thinning and bulging of the cornea analogous to keratoconus that becomes evident months or years after the LASIK procedure. Studies of patients who developed post-LASIK ectasia have led to a risk stratification system that uses preoperative information to evaluate the risk of developing post-LASIK ectasia. Approximately 1/3 of patients satisfy the conditions that correlate with developing post-LASIK ectasia. If a treatment were available with sufficiently low cost, low risk and high efficacy, patients in the "at risk" group might be treated prophylactically to greatly reduce the probability of subsequent ectasia. Some cases of post-LASIK ectasia occur in patients who have preoperative profiles that would not be identified as "at risk;" therefore, a safe and effective means to arrest the progression of ectasia as soon as it is identified is also needed. Corneal crosslinking using the riboflavin/UVA protocol pioneered by Wollensak, Seiler, and Spoerl, has shown promise in halting the progress of post-LASIK ectasia, providing a potential treatment to postpone or avoid corneal transpantation necessitated by the ectasia. However, the treatment is costly (requiring a surgeon to perform the 35 minute procedure), painful (requiring that the cornea be debrided) and toxic (the treatment kills all cells in the anterior 300 <400
Public Health Relevance Statement: Post-laser in situ keratomileusis (LASIK) ectasia is a serious complication of refractive corneal procedures resulting in progressive steepening and thinning of the cornea that can lead to severe visual loss and require corneal transplantation. This project will result in an innovative light-activated treatment that will arrest post-LASIK ectasia for those who already developed it and will serve as a preventative measure for others who are receiving the refractive correction procedure.
Project Terms: Abscission; Actinic Rays; After Care; After-Treatment; Aftercare; Animals; Anterior; Apoptosis; Apoptosis Pathway; Assay; Attenuated; Au element; Beds; Bioassay; Biologic Assays; Biological Assay; Blindness; Body Tissues; Cell Death, Programmed; Cells; Clinical Trials; Clinical Trials, Phase II; Clinical Trials, Unspecified; Collaborations; Complication; Computer Simulation; Computerized Models; Cornea; Corneal Stroma; Corneal Transplantation; Defect; Devices; Diffuse; Diffusion; Dilatation; Dilatation, Pathologic; Disadvantaged; Disease Progression; Drops; Dropsy; Drug Administration, Topical; Drug Formulations; Drugs; Ectasia; Edema; Electromagnetic, Laser; Endothelial Cells; Endothelium; Eosin; Eosin Y; Eosine Yellowish; Eosine Yellowish-; Epithelium, Anterior Corneal; Epithelium, Corneal; Event; Excision; Exposure to; Extirpation; Eye; Eyeball; FDA approved; Family suidae; Flaps; Formulation; Formulations, Drug; Gel; Gold; Grafting, Corneal; Human; Human, General; Hydrops; In Situ; In Vitro; Intraocular Pressure; Investigation; Island Flaps; Keratoconus; Keratomileusis, Laser In Situ; Keratoplasty; Killings; LASIK; Laser In Situ Keratomileusis; Laser Intrastromal Keratomileuses; Laser Intrastromal Keratomileusis; Laser-Assisted Stromal In Situ Keratomileusis; Lasers; Lead; Lifting; Light; Mammals, Rabbits; Man (Taxonomy); Man, Modern; Mathematical Model Simulation; Mathematical Models and Simulations; Measures; Mechanics; Medication; Methods; Modeling; Models, Computer; Ocular Tension; Operation; Operative Procedures; Operative Surgical Procedures; Oryctolagus cuniculus; Pain; Painful; Pathological Dilatation; Patients; Pb element; Pharmaceutic Preparations; Pharmaceutical Preparations; Phase; Phase 2 Clinical Trials; Phase II Clinical Trials; Photoradiation; Physiologic Intraocular Pressure; Pigs; Porifera; Position; Positioning Attribute; Probability; Procedures; Protocol; Protocols documentation; Rabbit, Domestic; Rabbits; Radiation, Laser; Radiation, Visible; Radiation, Visible Light; Removal; Residual; Residual state; Retinal; Riboflavin; Risk; STTR; Safety; Shapes; Simulation, Computer based; Small Business Technology Transfer Research; Solutions; Source; Sponges; Sponges (Zoology); Staging; Sterility; Stratification; Structure of corneal epithelium; Suidae; Sun/Ultra-Violet Rays; Surface; Surgeon; Surgical; Surgical Flaps; Surgical Interventions; Surgical Procedure; Surgical Removal; Swine; System; System, LOINC Axis 4; Testing; Tetrabromofluorescein; Therapeutic; Thick; Thickness; Time; Tissues; Topical application; Toxic effect; Toxicities; Toxicity Testing; Toxicity Tests; Translating; Translatings; Transplantation, Cornea; UV radiation; Ultraviolet Rays; United States; Visible Light; Visible Radiation; Visual; Vitamin B 2; Vitamin B2; Vitamin G; YS; biocompatibility; biomaterial compatibility; clinical applicability; clinical application; clinical investigation; computational modeling; computational models; computational simulation; computer based models; computerized modeling; computerized simulation; corneal; corneal epithelial; corneal epithelium; corneal keratoplasty; corneal transplant; cost; cross-link; crosslink; cytotoxic; design; designing; drug/agent; experiment; experimental research; experimental study; heavy metal Pb; heavy metal lead; high risk; in silico; in vitro testing; in vivo; innovate; innovation; innovative; irradiation; keratomileusis; language translation; light intensity; light treatment; macula; macular; novel; phase 2 study; phase 2 trial; phase II trial; porcine; prevent; preventing; prophylactic; protocol, phase II; public health relevance; research study; resection; sterile; study, phase II; suid; surgery; time interval; tool; topical administration; topical drug application; topically applied; ultraviolet light; ultraviolet radiation; virtual simulation
