Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Riboflavin/Dextran or Riboflavin/Methylcellulose
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Corneal Ectasia
- Keratoconus
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 125 years
- Gender
- Both males and females
Description
This study will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature. Subjects will be randomized to one of 2 groups. One group will be treated with a methylcellulose riboflavin solution and the o...
This study will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature. Subjects will be randomized to one of 2 groups. One group will be treated with a methylcellulose riboflavin solution and the other group will be treated with a dextran riboflavin solution. Both groups will be exposed to 3mW/cm2 of continuous UVA light for a total of 30 minutes; each group will continue to be administered the designated riboflavin drops during UV exposure. The primary efficacy parameter that will be evaluated over time is maximum keratometry (Kmax) in the randomized eyes for each treatment group. The secondary efficacy parameter will be to determine if the two treatment groups equivalent in their Kmax change at 12 months after treatment compared with baseline.
Tracking Information
- NCT #
- NCT04897503
- Collaborators
- Not Provided
- Investigators
- Study Director: Peter S Hersh, MD Cornea and Laser Eye Institute Hersh Vision Group Principal Investigator: Steven A Greenstein, MD Cornea and Laser Eye Institute, Hersh Vision Group
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