Corneal Collagen Cross-linking for Progressive Keratoconus



Status:Completed
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:14 - Any
Updated:6/17/2018
Start Date:December 2007
End Date:April 2011

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Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus

Prospective, randomized multicenter study to determine the safety and effectiveness of
performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with
progressive keratoconus.

This was a sham controlled study for the first three months. Patients had one eye designated
as the study eye and were randomized to receive one of two study treatments (CXL or sham) in
their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later
patients had the option of receiving CXL treatment in both the sham and non-study eye.

Inclusion Criteria:

- Diagnosis of keratoconus

- Documented progression over previous 24 months

- Decreased BSCVA

- Must complete all study visits

Exclusion Criteria:

- Prior corneal surgery or Intacs

- History of delayed wound healing
We found this trial at
10
sites
Rockville Centre, New York 11570
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Rockville Centre, NY
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Baltimore, MD
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Indianapolis, Indiana 46260
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Indianapolis, IN
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8300 College Boulevard
Kansas City, Kansas 66211
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Kansas City, KS
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La Jolla, California 92093
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La Jolla, CA
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Miami, Florida 33176
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Miami, FL
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Minneapolis, Minnesota 55405
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Minneapolis, MN
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New York, NY
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San Diego, California 91222
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San Diego, CA
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Teaneck, NJ
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