Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas

Stopped early

Conditions studied: Keratoconus, Ectasia, Degeneration

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. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication. The data generated by this study will not be submitted to the FDA to support commercialization of these riboflavin drops.

Key facts

Study ID

NCT01189864

Run by

Cxlusa

People needed

3493

Starts

2010-02-01

Expected to finish

2017-02-03

Last updated by the study team

2018-10-12

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 12 years of age or older
• Diagnosis of keratoconus, FFKC, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration (FFPMD).
• Diagnosis of FFKC
• History of Radial Keratotomy with fluctuating vision
• Ability to provide written informed consent
• Likely to complete all study visits
• Minimum corneal thickness of at least 300 Measured by ultrasound or Pentacam
• At least 6 months since last corneal surgery (Intacs/PRK/LASIK/Epi-LASIK/LASEK)

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

• Schwartz Laser Eye Center — Scottsdale, Arizona, United States
• Harvard Eye Associates — Laguna Hills, California, United States
• Clear View Eye & Laser Medical Center — San Diego, California, United States
• Study site — San Francisco, California, United States
• Davidorf Eye Group — West Hills, California, United States
• Corneal Consultants of Colorado, P.C — Littleton, Colorado, United States
• The Center for Excellence in Eye Care — Miami, Florida, United States
• Chicago Cornea Consultants, LTD — Hoffman Estates, Illinois, United States
• TLC Laser Eye Center — Rockville, Maryland, United States
• Talamo Laser Eye Center — Waltham, Massachusetts, United States
• Ophthalomology Associates — St Louis, Missouri, United States
• South Shore Eye Care LLP — Wantagh, New York, United States
• Cleveland Eye Clinic — Brecksville, Ohio, United States
• TLC Laser Eye Center — Fairfax, Virginia, United States
• Northwest Eye Surgeons — Seattle, Washington, United States
• Empire Eye Physicians — Spokane Valley, Washington, United States

Full record on ClinicalTrials.gov

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