Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Terminated

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

• Registration Number: NCT01024322
• 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: 2009-10-01
• Study First Submitted: 2009-10-28
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Primary Completion: 2017-02-03
• Study Completion: 2017-02-03
• Status Verified: 2018-09
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1189

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.
• Terrien's Marginal Degeneration
• Ability to provide written informed consent
• Likely to complete all study visits
• Minimum corneal thickness of at least 300 250 microns measured by ultrasound or Pentacam for all indications other than Terriens. For Terriens, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.

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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

Arm && Interventions

Group	Intervention	Description
Ciprofloxicine or Vigamox or other.	Ciprofloxicine or Vigamox or other.	-
Nonsteroidal (Acular, Voltaren Xibrom, etc)	Nonsteroidal (Acular, Voltaren Xibrom, etc)	-
Steroid (FML, Pred Forte, Flarex, etc.)	Steroid (FML, Pred Forte, Flarex, 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 (2)

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

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