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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Corneal collagen crosslinking (CXL) has been demonstrated as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. Transepithelial crosslinking in which the epithelium is not removed has been proposed to offer a number of advantages over traditional crosslinking including an increased safety profile by reducing the risk for infection and scarring, faster visual recovery and improved patient comfort in the early postoperative healing period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cornea and Laser Eye Institute
• Treatments: Riboflavin

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