Transepithelial (Epi-on) Corneal Collagen Crosslinking to Treat Keratoconus and Corneal Ectasia

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

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called transepithelial corneal collagen crosslinking (CXL) for people with keratoconus or corneal ectasia, conditions that cause the cornea (the front part of the eye) to become misshapen. This method aims to strengthen the cornea without removing the surface layer, which may lead to fewer complications, quicker recovery, and better comfort for patients after the procedure. The trial is currently recruiting participants aged 12 and older who have been diagnosed with these conditions, especially if they have had corneal surgery like LASIK.

To participate, individuals must be willing to stop wearing contact lenses for a week before the screening and be able to attend follow-up appointments. However, those with certain eye conditions, a history of complications, or other specific health issues may not be eligible. Participants can expect to receive the CXL treatment and will be monitored closely to assess its effectiveness and safety. This trial represents an exciting opportunity to explore a potentially safer way to treat these challenging 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 (e.g., LASIK, photorefractive keratectomy \[PRK\])
• • 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 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 erosion syndrome, corneal melt, corneal dystrophy, etc.)
• • 2. Clinically significant corneal scaring 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