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

Launched by CORNEA AND LASER EYE INSTITUTE · May 18, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called corneal collagen crosslinking (CXL) for people with keratoconus and corneal ectasia. These are conditions that cause the cornea, the clear front part of the eye, to become misshapen, which can lead to vision problems. The researchers want to see if using two different types of a vitamin solution called riboflavin, combined with other substances, can safely improve the shape of the cornea and make vision better.

To be eligible for the trial, participants need to be at least 12 years old and have a diagnosis of keratoconus or corneal ectasia. They should also have certain specific findings on eye tests that show the cornea is steepening. Participants will need to stop wearing contact lenses for a week before the trial starts and be willing to come back for follow-up visits. Throughout the study, participants will be monitored closely to ensure their safety and to see how well the treatment works. If you or a loved one think you might qualify, it could be a great opportunity to help advance treatment for these eye conditions.

Gender

ALL

Eligibility criteria

• 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 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