NCT04731727

Treating Corneal Thinning Conditions With CCL Vario Riboflavin (CXL)

Safety and Effectiveness of the CCL Vario System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Kent Wellish MD · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Study is testing the efficacy of treating corneal thinning conditions with Vitamin B2 (Riboflavin) and the application on UV Light.

Detailed description

Corneal thinning conditions, i.e. keratoconus or ectasia, weaken the cornea which then causes the front of the eye to bulge out. This results in distorted vision and could eventually result in the need for a cornea transplant. This study proposes to conclude that saturating the cornea with vitamin B2 (Riboflavin) and then applying 365nm wavelength of Ultra Violet Light will result in the various layers of corneal tissue linking together. This cross linking results in a stronger cornea which is designed to halt the progression of keratoconus or ectasia. This treatment is already being successfully used in Europe.

Conditions

• Keratoconus, Unstable

Interventions

Type	Name	Description
DRUG	Riboflavin	Corneal cross linking achieved by combination of Riboflavin and ultraviolet light

Timeline

• Start date: 2021-06-30
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2021-02-01
• Last updated: 2021-05-25

Regulatory

• FDA-regulated drug study