Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)

Terminated

• Conditions: Ectasia; Degeneration; Keratoconus

• Registration Number: NCT01097447
• Lead Sponsor: Cxlusa

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-01
• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-03-31
• Study First Posted: 2010-04-01
• Primary Completion: 2017-04-30
• Study Completion: 2017-04-30
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2619

Inclusion Criteria

• 8 years of age or older
• Diagnosis of keratoconus, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration.
• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within	1 year

Secondary Outcome Measures

Name	Time	Method
increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin	1 year

Trial Locations

Locations (5)

Chicago Cornea Consultants, LTD; 🇺🇸 Hoffman Estates, Illinois, United States

Corneal Consultants of Colorado, P.C; 🇺🇸 Littleton, Colorado, United States

Clear View Eye & Laser Medical Center; 🇺🇸 San Diego, California, United States

Cornea Associates of Texas; 🇺🇸 Dallas, Texas, United States

Minnesota Eye Consultants, P.A.; 🇺🇸 Bloomington, Minnesota, United States