Status:
UNKNOWN
Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Riboflavin/Dextran or Riboflavin/Methylcellulose
Lead Sponsor:
Cornea and Laser Eye Institute
Conditions:
Keratoconus
Corneal Ectasia
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This study is being conducted to evaluate the safety and efficacy of isotonic riboflavin for corneal collagen crosslinking for keratoconus and corneal ectasia. will determine the safety and efficacy o...
Detailed Description
This study will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature. Subjects will be randomize...
Eligibility Criteria
Inclusion
- 12 years of age or older
- Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
- 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 lens 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 less than or equal to 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, for example: History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) Clinically significant corneal scarring 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 :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04897503
Start Date
April 16 2021
End Date
December 1 2025
Last Update
January 4 2023
Active Locations (1)
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1
Cornea and Laser Eye Institue - Hersh Vision Group
Teaneck, New Jersey, United States, 07666