CXL-04 A Study of Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Stopped early · Phase 2

Conditions studied: Keratoconus

In brief

The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin.

Key facts

Study ID

NCT01956474

Run by

Cxlusa

People needed

1324

Starts

2013-01-01

Expected to finish

2017-02-03

Last updated by the study team

2018-10-12

Who can join

Age: 8 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 8 years of age or older
• Having at least one of the following conditions:
• Keratoconus
• Post-LASIK ectasia
• Pellucid marginal degeneration
• Forme fruste pellucid marginal degeneration
• FFKC
• History of Radial Keratotomy with fluctuating vision.
• Terrien's Marginal Degeneration
• Signed written informed consent and/or assent
• Likely to complete all study visits
• Minimum corneal thickness of at least 250 microns measured by ultrasound or Pentacam for all indications other than Terrien's. For Terrien's, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.

You may not qualify if…

• Severe corneal scarring that markedly affects vision
• Contraindications to any study medications or their components
• Pregnancy or breast feeding
• Active Herpes Corneal Disease

Where it is running

• Center for Excellence in Eye Care — Miami, Florida, United States
• Stulting Research Center at Woolfson Eye Institute — Atlanta, Georgia, United States
• TLC Laser Eye Center — Rockville, Maryland, United States
• Talamo Hatch Laser Eye Consultants, LLC — Boston, Massachusetts, United States
• Cleveland Eye Clinic — Brecksville, Ohio, United States
• TLC Laser Eye Center — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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