Corneal Crosslinking for Keratoconus

This trial explores whether corneal crosslinking (CXL) can prevent or slow vision loss in individuals with conditions like keratoconus, which thin and misshape the cornea. CXL involves applying vitamin B2 eye drops and exposing the eye to UV light to strengthen the cornea. Participants will be divided into two groups, receiving UV light for either 18 or 24 minutes. Individuals diagnosed with keratoconus or similar corneal conditions affecting vision might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

The trial information does not specify whether you need to stop taking your current medications. However, if you wear contact lenses, you will need to stop wearing them for a certain period before examinations.

Studies have shown that the Epi-ON corneal crosslinking (CXL) treatment is generally safe for people with keratoconus. In one study, no patients experienced corneal cloudiness after receiving Epi-ON CXL, suggesting the treatment is well-tolerated. Another study found that both Epi-ON and epithelium-off CXL treatments remained safe over a 12-month period.

Epi-ON Corneal Collagen Crosslinking is unique because it represents a less invasive option for treating keratoconus, a condition that causes the cornea to thin and bulge. Unlike traditional Epi-OFF crosslinking, which involves removing the cornea's outer layer, Epi-ON keeps it intact, potentially reducing recovery time and discomfort. Researchers are excited because this method uses UVA light and riboflavin to strengthen the cornea with shorter irradiation times, aiming to provide effective results with fewer side effects. By offering a gentler approach, Epi-ON could make treatment more accessible and appealing to patients.

Research has shown that Epi-ON corneal collagen crosslinking (CXL) can effectively slow or halt the progression of keratoconus. One study found that it significantly improved vision clarity and stopped the disease from advancing. Additionally, patients who underwent Epi-ON CXL did not experience issues such as cloudiness or corneal damage. While both Epi-ON and Epi-OFF methods are available, Epi-ON is gentler on the eye's surface. Overall, CXL strengthens the cornea, helping to stabilize vision in people with keratoconus.