Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Cxlusa1,189 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,189

Conditions

Keratoconus Ectasia Degeneration

Interventions

Ciprofloxicine or Vigamox or other.DRUG

Ciprofloxicine or Vigamox or other to be used qid till epithelialized.

Nonsteroidal (Acular, Voltaren Xibrom, etc)DRUG

Nonsteroidal (Acular, Voltaren Xibrom, etc) used up to qid for up to 5-10 days post-op

Steroid (FML, Pred Forte, Flarex, etc.)DRUG

Steroid (FML, Pred Forte, Flarex, etc.) to be used qid for 8 weeks.

Eligibility

Sex: ALLMin age: 8 Years

Medical Language ↔ Plain English

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. 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

Locations (3)

The Center for Excellence in Eye Care

Miami, Florida, United States

TLC Laser Eye Center

Rockville, Maryland, United States

TLC Laser Eye Center

Fairfax, Virginia, United States

Outcomes

Primary Outcomes

Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within

Time frame: 1 year

Secondary Outcomes

increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin

Time frame: 1 year

Data from ClinicalTrials.gov

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