Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Riboflavin/Dextran or Riboflavin/Methylcellulose

Last updated: December 30, 2022
Sponsor: Cornea and Laser Eye Institute
Overall Status: Active - Recruiting

Phase

3

Condition

Vision Loss

Eye Disease

Treatment

N/A

Clinical Study ID

NCT04897503
CLEI - ISO-CXL-001
  • Ages > 12
  • All Genders
  • Accepts Healthy Volunteers

Study 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 of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 weekprior to the screening refraction
  • Signed written informed consent
  • Willingness and ability to comply with schedule for follow-up visits

Exclusion

Exclusion Criteria:

  • Eyes classified as either normal, atypical normal, or keratoconus suspect on theseverity grading scheme
  • Corneal pachymetry less than or equal to 300 microns at the thinnest point measured byPentacam in the eye(s) to be treated
  • Previous ocular condition (other than refractive error) in the eye(s) to be treatedthat may predispose the eye for future complications, for example: History of cornealdisease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome,corneal melt, corneal dystrophy, etc.) Clinically significant corneal scarring in theCXL 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 thestudy
  • A known sensitivity to study medications
  • Patients with nystagmus or any other condition that would prevent a steady gaze duringthe CXL treatment or other diagnostic tests
  • Patients with a current condition that, in the investigator's opinion, would interferewith or prolong epithelial healing

Study Design

Total Participants: 170
Study Start date:
April 16, 2021
Estimated Completion Date:
December 31, 2025

Study 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 randomized to one of 2 groups. One group will be treated with a methylcellulose riboflavin solution and the other group will be treated with a dextran riboflavin solution. Both groups will be exposed to 3mW/cm2 of continuous UVA light for a total of 30 minutes; each group will continue to be administered the designated riboflavin drops during UV exposure.

The primary efficacy parameter that will be evaluated over time is maximum keratometry (Kmax) in the randomized eyes for each treatment group.

The secondary efficacy parameter will be to determine if the two treatment groups equivalent in their Kmax change at 12 months after treatment compared with baseline.

Connect with a study center

  • Cornea and Laser Eye Institue - Hersh Vision Group

    Teaneck, New Jersey 07666
    United States

    Active - Recruiting

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