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

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Corneal collagen crosslinking has been demonstrated as an effective method of reducing progression of both keratoconus and post-refractive corneal ectasia, as well as decreasing the steepness of the cornea in these pathologies.

Performing an accelerated CXL procedure with pulsed UVA light may increase the oxygenation of the cornea, which may improve the crosslinking efficacy.

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

Details

• Lead Sponsor: Cornea and Laser Eye Institute
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions; Riboflavin

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