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

Terminated

• Conditions: Keratoconus; Ectasia; Degeneration
• Interventions: Drug: Ciprofloxicin or Vigamox or other.; Drug: Steroid (FML, Pred Forte, Flarex, etc.); Drug: Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)

• Registration Number: NCT01189864
• Lead Sponsor: Cxlusa

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-01
• Study First Submitted: 2010-07-20
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-27
• Primary Completion: 2017-02-03
• Study Completion: 2017-02-03
• Status Verified: 2018-09
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3493

Inclusion Criteria

• 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)

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ciprofloxicin or Vigamox or other.	Ciprofloxicin or Vigamox or other.	-
Steroid (FML, Pred Forte, Flarex, etc.)	Steroid (FML, Pred Forte, Flarex, etc.)	-
Nonsteroidal (Acular, Voltaren Xibrom, etc)	Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)	-

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 (14)

Schwartz Laser Eye Center; 🇺🇸 Scottsdale, Arizona, United States

Talamo Laser Eye Center; 🇺🇸 Waltham, Massachusetts, United States

Ophthalomology Associates; 🇺🇸 Saint Louis, Missouri, United States

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

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

Davidorf Eye Group; 🇺🇸 West Hills, California, United States

South Shore Eye Care LLP; 🇺🇸 Wantagh, New York, United States

Cleveland Eye Clinic; 🇺🇸 Brecksville, Ohio, United States

Empire Eye Physicians; 🇺🇸 Spokane Valley, Washington, United States

Harvard Eye Associates; 🇺🇸 Laguna Hills, California, United States

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

The Center for Excellence in Eye Care; 🇺🇸 Miami, Florida, United States

TLC Laser Eye Center; 🇺🇸 Fairfax, Virginia, United States

Northwest Eye Surgeons; 🇺🇸 Seattle, Washington, United States