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



Status:Terminated
Conditions:Ocular, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Ophthalmology
Healthy:No
Age Range:12 - Any
Updated:10/14/2018
Start Date:February 1, 2010
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. 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.


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
We found this trial at
16
sites
Saint Louis, Missouri
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Saint Louis, MO
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Brecksville, Ohio 44141
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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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Hoffman Estates, Illinois
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Hoffman Estates, IL
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Laguna Hills, California 92653
Principal Investigator: John Hovanesian, MD
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Laguna Hills, CA
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Littleton, CO
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Miami, Florida 33176
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Miami, FL
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Rockville, Maryland 20852
Principal Investigator: Marc Levy, OD
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Rockville, MD
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San Diego, California 92121
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San Diego, CA
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San Francisco, California
Principal Investigator: Daniel Goodman, MD
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San Francisco, CA
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8416 E. Shea Blvd., Ste C-101
Scottsdale, Arizona 85260
Principal Investigator: Jay Schwartz, MD
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Scottsdale, AZ
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Seattle, Washington
Principal Investigator: Audrey Rostov, MD
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from
Seattle, WA
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Spokane Valley, Washington
Principal Investigator: Mark Kontos, MD
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Spokane Valley, WA
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Waltham, Massachusetts
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from
Waltham, MA
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Wantagh, New York 11793
Principal Investigator: Jodi Luchs, MD
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Wantagh, NY
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West Hills, California
Principal Investigator: Jonathan Davidorf, MD
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from
West Hills, CA
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