CXL-04 A Study of Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas



Status:Terminated
Conditions:Ocular, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Ophthalmology
Healthy:No
Age Range:8 - Any
Updated:10/14/2018
Start Date:January 2013
End Date:February 3, 2017

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Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

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.

This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with
conditions that include Keratoconus, Pellucid Marginal degeneration, Post-LASIK ectasia, and
patients with radial keratotomy who experience fluctuation in their vision. This is an
outcomes study, all patients receive treatment.

Inclusion Criteria:

1. 8 years of age or older

2. Having at least one of the following conditions:

- Keratoconus

- Post-LASIK ectasia

- Pellucid marginal degeneration

- Forme fruste pellucid marginal degeneration

- FFKC

- History of Radial Keratotomy with fluctuating vision.

- Terrien's Marginal Degeneration

3. Signed written informed consent and/or assent

4. Likely to complete all study visits

5. Minimum corneal thickness of at least 250 microns measured by ultrasound or Pentacam
for all indications other than Terrien's. For Terrien's, the minimal corneal thickness
should be consistent with the surgeon's best surgical judgment.

Exclusion Criteria:

1. Severe corneal scarring that markedly affects vision

2. Contraindications to any study medications or their components

3. Pregnancy or breast feeding

4. Active Herpes Corneal Disease
We found this trial at
6
sites
Atlanta, Georgia 30328
Principal Investigator: Robert Stulting, MD
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Atlanta, GA
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Boston, Massachusetts 02451
Principal Investigator: Johnathan Talamo, MD
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Boston, MA
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Brecksville, Ohio 44141
Principal Investigator: Shamik Bafna, MD
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Brecksville, OH
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Fairfax, Virginia 22031
Principal Investigator: Marc Levy, OD
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Fairfax, VA
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Miami, Florida 33176
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Miami, FL
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Rockville, Maryland 20852
Principal Investigator: Levy Marc, OD
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Rockville, MD
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