Corneal Collagen Crosslinking and Intacs for Keratoconus and Ectasia

Status unconfirmed · Phase 3

Conditions studied: Keratoconus, Corneal Ectasia

In brief

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.

Key facts

Study ID

NCT01112072

Run by

Cornea and Laser Eye Institute

People needed

160

Starts

2010-04-01

Expected to finish

2025-12-01

Last updated by the study team

2023-02-08

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Cornea and Laser Eye Institute — Teaneck, New Jersey, United States

Full record on ClinicalTrials.gov

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