Corneal Collagen Crosslinking and Intacs for Keratoconus and Ectasia

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

Summary

This study will determine the efficacy of corneal collagen crosslinking (CXL) combined with Intacs for the treatment of keratoconus and corneal ectasia. The goal of CXL is to decrease the progression of keratoconus, while Intacs has been shown to decrease corneal steepness in keratoconus. This study will attempt to determine the relative efficacy of the two procedures either performed at the same session versus CXL performed 3 months after Intacs.

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

Details

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

Criteria

Inclusion Criteria:

• 21 years of age or older

• Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy [PRK], or epi-LASIK)

• Subjects who meet the manufacturer's nomogram recommendations for Intacs segments

• Topography consistent with keratoconus or post-surgical corneal ectasia.

• BSCVA worse than 20/20 (<55 letters on ETDRS chart)

Exclusion Criteria:

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

• Corneal pachymetry ≤ 400 microns at the thinnest point measured by Pentacam in the eye(s) to be treated when the isotonic riboflavin solution is used or ≤ 300 microns when the hypotonic riboflavin us used, provided that the corneal thickness after treatment with the hypotonic riboflavin solution is > 400 microns. Corneal pachymetry ≤ 450 microns at the proposed insertion site for the Intacs

• Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications

• History of corneal disease

• 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

• Subjects with nystagmus or any other condition that would prevent a steady gaze during the CXL and Intacs treatment or other diagnostic tests.

• Subjects with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.