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

  • End date
    Dec 1, 2023
  • participants needed
  • sponsor
    Cornea and Laser Eye Institute
Updated on 1 September 2021


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.


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.

Condition Keratoconus, Corneal Ectasia
Treatment Riboflavin
Clinical Study IdentifierNCT04897503
SponsorCornea and Laser Eye Institute
Last Modified on1 September 2021


Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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