Corneal collagen crosslinking for keratoconus and ectasia using different riboflavin solutions
Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking Using Riboflavin/Dextran or Riboflavin/Methylcellulose
This study is testing two different riboflavin solutions to see which one works better in treating keratoconus and corneal ectasia by reducing corneal curvature.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Cornea and Laser Eye Institute Academic / other |
| Locations | 1 site (Teaneck, New Jersey) |
| Trial ID | NCT04897503 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of corneal collagen crosslinking (CXL) using two different riboflavin formulations: methylcellulose and dextran. Participants will be randomized into two groups, each receiving one of the riboflavin solutions while being exposed to UVA light for 30 minutes. The primary outcome will measure changes in maximum keratometry (Kmax) over time, with a secondary goal of comparing the efficacy of both treatments at 12 months post-treatment. The study aims to determine which formulation is more effective in reducing corneal curvature in patients with keratoconus or corneal ectasia.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 12 years or older diagnosed with keratoconus or corneal ectasia after corneal refractive surgery.
Not a fit: Patients with corneal thickness less than or equal to 300 microns or those with normal or atypical normal corneas will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective option for patients with keratoconus and corneal ectasia, potentially improving their vision and quality of life.
How similar studies have performed: Previous studies have shown promising results with corneal collagen crosslinking, making this approach a well-established treatment for keratoconus and ectasia.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 12 years of age or older * Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery * Presence of central or inferior steepening on the Pentacam map * Axial topography consistent with keratoconus or post-surgical corneal ectasia * Contact lens wearers only: removal of contact lens for the required period of 1 week prior to the screening refraction * Signed written informed consent * Willingness and ability to comply with schedule for follow-up visits Exclusion Criteria: * Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme * Corneal pachymetry less than or equal to 300 microns at the thinnest point measured by Pentacam in the eye(s) to be treated * Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example: History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) Clinically significant corneal scarring in the CXL treatment zone * A history of chemical injury or delayed epithelial healing in the eye(s) to be treated * Pregnancy (including plan to become pregnant) or lactation during the course of the study * A known sensitivity to study medications * Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests * Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing
Where this trial is running
Teaneck, New Jersey
- Cornea and Laser Eye Institue - Hersh Vision Group — Teaneck, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Steven A Greenstein, MD — Cornea and Laser Eye Institute, Hersh Vision Group
- Study coordinator: BethAnn Furlong-Hibbert
- Email: bafhibbert@yahoo.com
- Phone: 1 201 692-9434
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.