Study of Epi-ON Corneal Crosslinking Using UVA Light to Treat Ectatic Corneal Diseases in Children and Adults With Down Syndrome

What this Trial Is About

Researchers are studying an experimental treatment called corneal crosslinking CXL for people with Down syndrome who have corneal conditions where the cornea thins, steepens, and becomes misshapen, causing blurred vision. This treatment aims to strengthen the cornea and possibly prevent or slow vision loss. The study focuses on whether CXL can stop or slow this progression. Participants must be at least 8 years old and diagnosed with Down syndrome or similar cognitive or developmental conditions. The treatment involves applying riboflavin Vitamin B2 eye drops to the eye, followed by exposure to ultraviolet A UVA light for 20 minutes. This process is called Epi-ON corneal cross-linking and is performed during the study. Participants will receive this treatment and be monitored over a 6-month period. Participants will attend up to 7 in-office visits during the 6 months, where various eye and vision tests will be conducted. Researchers will measure corneal curvature and vision changes using tools like the Pentacam and visual acuity tests. They will also assess vision improvements with additional measures such as high order aberrations and coma. The study includes follow-up visits to track treatment effects and safety over time.

Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome