Accelerated Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Pulse or Continuous UV-A Light

Launched by CORNEA AND LASER EYE INSTITUTE · Aug 24, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat keratoconus and corneal ectasia, which are conditions that affect the shape and health of the cornea (the clear front part of the eye). The researchers want to find out if using a special technique called accelerated corneal collagen crosslinking (CXL) with pulsed UV-A light can improve the treatment’s effectiveness. Previous methods have helped slow down the worsening of these conditions, and this trial aims to see if the new method can work even better by increasing the oxygen supply to the cornea.

To be eligible for this trial, participants need to be at least 18 years old and have a diagnosis of keratoconus or corneal ectasia after having eye surgery. They should also have specific signs of these conditions seen in eye tests. Participants will need to stop wearing contact lenses for a week before their initial screening and must be willing to attend follow-up visits. Throughout the trial, participants can expect to undergo the accelerated CXL procedure and will be monitored for their recovery and any effects of the treatment. It’s important to note that some individuals may not qualify due to other eye conditions or health issues, so discussing eligibility with a doctor is essential.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years of age or older having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
• • Presence of central or inferior corneal steepening on the Pentacam map
• • Axial topography consistent with keratoconus or post-surgical corneal ectasia
• • Contact lens wearers only: removal of contact lenses 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 measuring 300 microns or less 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:
• • 1. History of corneal disease (e.g. herpes simplex, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal melt, corneal dystrophy, etc.
• • 2. Clinically significant scarring in the CXL treatment zone
• • A history of chemical injury or delayed 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 current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing