Accelerated corneal collagen crosslinking for keratoconus and ectasia
A Randomized Study to Evaluate the Safety and Efficacy of Corneal Collagen Crosslinking Performed With Continuous vs Pulsed UVA Light for Reducing Corneal Curvature in Eyes With Keratoconus and Post-refractive Corneal Ectasia
This study is testing if using continuous or pulsed UVA light for a new corneal treatment can help people with keratoconus and corneal ectasia see better and feel more comfortable.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cornea and Laser Eye Institute Academic / other |
| Locations | 1 site (Teaneck, New Jersey) |
| Trial ID | NCT05027295 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of accelerated corneal collagen crosslinking using either continuous or pulsed UVA light in patients with keratoconus and corneal ectasia. The study aims to compare the safety and efficacy of these two treatment methods by analyzing changes in maximum keratometry (Kmax) over a six-month period. Participants will be randomized into two groups, one receiving continuous UVA light and the other receiving pulsed UVA light, both with the same total energy delivered to the cornea. The goal is to determine if the accelerated treatment can maintain or improve outcomes compared to standard methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with keratoconus or corneal ectasia following corneal refractive surgery.
Not a fit: Patients with normal or atypical corneas, or those with significant corneal thinning, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a faster and potentially more effective treatment option for patients with keratoconus and corneal ectasia.
How similar studies have performed: Previous studies have shown that corneal collagen crosslinking is effective, but this specific approach using pulsed UVA light is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery * Presence of central or inferior corneal steepening on the Pentacam map * Axial topography consistent with keratoconus or post-surgical corneal ectasia * Contact lens wearers only: removal of contact lenses 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 measuring 300 microns or less 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: 1. History of corneal disease (e.g. herpes simplex, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal melt, corneal dystrophy, etc. 2. Clinically significant scarring in the CXL treatment zone * A history of chemical injury or delayed 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 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 Institute, Hersh Vision Group — Teaneck, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: BethAnn Furlong-Hibbert
- Email: bfurlong-hibbert@vision-institute.com
- Phone: (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.