Status:
UNKNOWN
Transepithelial (Epi-on) Corneal Collagen Crosslinking to Treat Keratoconus and Corneal Ectasia
Lead Sponsor:
Cornea and Laser Eye Institute
Conditions:
Keratoconus
Corneal Ectasia
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
Corneal collagen crosslinking (CXL) has been demonstrated as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steep...
Detailed Description
The objective of this randomized study is to investigate the difference between two regimens of transepithelial crosslinking. The study will compare two riboflavin dosing regimens during the crosslink...
Eligibility Criteria
Inclusion
- 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
- 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:
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
- 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
Key Trial Info
Start Date :
June 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04905108
Start Date
June 2 2021
End Date
December 1 2025
Last Update
January 4 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cornea and Laser Eye Institute, Hersh Vision Group
Teaneck, New Jersey, United States, 07666