Status:
UNKNOWN
Corneal Collagen Crosslinking for Progressive Keratoconus and Ectasia Using Riboflavin/Dextran and Hypotonic Riboflavin
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 the two riboflavin preparations during UV (ultraviolet) administration. Both riboflavin preparations currently are in general use w...
Eligibility Criteria
Inclusion
- 18 years of age or older
- A diagnosis of progressive keratoconus over a period of 24 months or less before randomization 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 300 microns at the thinnest point
Exclusion
- Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
- Corneal pachymetry ≤ 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
- 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 :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01152541
Start Date
June 1 2010
End Date
December 1 2025
Last Update
February 8 2023
Active Locations (1)
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1
Cornea and Laser Eye Institute
Teaneck, New Jersey, United States, 07666