Corneal Collagen Crosslinking for Keratoconus
(CXL Trial)
Trial Summary
What is the purpose of this trial?
This study is being conducted to evaluate the safety and efficacy of isotonic riboflavin for corneal collagen crosslinking for keratoconus and corneal ectasia. will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it does mention that contact lens wearers need to stop wearing them for a week before screening.
What data supports the effectiveness of the treatment Riboflavin ophthalmic solution for keratoconus?
Research shows that using riboflavin with UV-A light in corneal collagen cross-linking helps improve vision and stabilize keratoconus, a condition where the cornea becomes thin and cone-shaped. This method is less invasive and addresses the root cause of the condition, making it effective in treating keratoconus.12345
Is corneal collagen crosslinking with riboflavin safe for humans?
How is the treatment for keratoconus using riboflavin unique?
Corneal collagen crosslinking with riboflavin is unique because it strengthens the cornea by using a combination of riboflavin (Vitamin B2) and ultraviolet-A light, which helps to halt the progression of keratoconus, a condition where the cornea becomes thin and cone-shaped. This treatment is different from other options as it directly targets the structural integrity of the cornea rather than just correcting vision.810111213
Research Team
Peter S Hersh, MD
Principal Investigator
Cornea and Laser Eye Institute Hersh Vision Group
Steven A Greenstein, MD
Principal Investigator
Cornea and Laser Eye Institute, Hersh Vision Group
Eligibility Criteria
This trial is for people aged 12 or older with keratoconus or corneal ectasia, who can remove their contact lenses a week before testing and attend follow-up visits. Pregnant individuals, those with thin corneas, previous eye conditions that may cause complications, or sensitivity to study medications cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive corneal collagen crosslinking using either riboflavin/dextran or riboflavin/methylcellulose solution with UVA light exposure
Follow-up
Participants are monitored for safety and effectiveness after treatment, with evaluations of maximum keratometry and visual acuity
Treatment Details
Interventions
- Riboflavin
Riboflavin is already approved in United States, European Union for the following indications:
- Progressive keratoconus
- Corneal ectasia following refractive surgery
- Progressive keratoconus
- Corneal ectasia following refractive surgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cornea and Laser Eye Institute
Lead Sponsor