Status:
UNKNOWN
Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia
Lead Sponsor:
Cornea and Laser Eye Institute
Conditions:
Keratoconus
Corneal Ectasia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Corneal collagen crosslinking (CXL) has been proposed as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness...
Detailed Description
The objective of this study is to investigate the difference between two regimens of transepithelial crosslinking. The study will compare two riboflavin dosing regimens during the crosslinking procedu...
Eligibility Criteria
Inclusion
- 18 years of age or older
- A diagnosis of keratoconus or a diagnosis of corneal ectasia after corneal refractive surgery
- Vision with contact lenses or glasses is worse than 20/20
- Corneal thickness greater than 375 microns at the thinnest point
Exclusion
- Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
- Corneal pachymetry ≤ 350 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
- Clinically significant corneal scarring in the CXL treatment zone
- 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 :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01464268
Start Date
November 1 2011
End Date
December 1 2025
Last Update
February 8 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cornea and Laser Eye Institute
Teaneck, New Jersey, United States, 07666