Corneal Collagen Crosslinking for Progressive Keratoconus and Ectasia Using Riboflavin/Dextran and Hypotonic Riboflavin

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Corneal collagen crosslinking (CXL) has been proposed 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. During the CXL procedure, the central corneal thickness has been shown to significantly change. The investigator's believe that better maintenance of corneal thickness potentially could have benefits of better reproducibility of the crosslinking effect with improved predictability of results.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• 18 years of age or older

• A diagnosis of progressive keratoconus over a period of 24 months or less before randomization or a diagnosis of corneal ectasia after corneal refractive surgery

• Vision with contact lenses or glasses is worse than 20/20

• Corneal thickness greater than 300 microns at the thinnest point

Exclusion Criteria:

• Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.

• Corneal pachymetry ≤ 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

• Clinically significant corneal scarring in the CXL treatment zone

• 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.