Transepithelial corneal collagen crosslinking for keratoconus and corneal ectasia
Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking Using Two Different Riboflavin Administration Protocols
This study tests if two different ways of applying riboflavin during a new eye treatment can improve vision and corneal shape for people with keratoconus or corneal ectasia.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Cornea and Laser Eye Institute Academic / other |
| Locations | 1 site (Teaneck, New Jersey) |
| Trial ID | NCT04905108 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of transepithelial corneal collagen crosslinking using two different riboflavin dosing regimens. The study aims to determine how these regimens impact corneal curvature and visual acuity in patients diagnosed with keratoconus or corneal ectasia. Participants will undergo a randomized procedure where their outcomes will be compared based on the riboflavin administration during the UVA treatment phase. The trial also assesses safety through monitoring adverse events and changes in visual acuity.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 12 years or older with a diagnosis of keratoconus or corneal ectasia following corneal refractive surgery.
Not a fit: Patients with normal corneas or those with corneal thickness below 300 microns are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more comfortable option for patients with keratoconus and corneal ectasia, potentially improving their vision and quality of life.
How similar studies have performed: Previous studies on corneal collagen crosslinking have shown promising results, indicating that this approach may be effective, though the specific transepithelial method is still being evaluated.
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 (e.g., LASIK, photorefractive keratectomy \[PRK\]) * 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 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 erosion syndrome, corneal melt, corneal dystrophy, etc.) 2. Clinically significant corneal scaring 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 Institute, 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: 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.