Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
103 participants
INTERVENTIONAL
2010-12-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sham Control
Riboflavin
Both treatment and sham groups will receive riboflavin
CXL Treatment
VEGA UV-A Illumination System
Only subjects assigned to the treatment group will receive treatment with the UV Light
Riboflavin
Both treatment and sham groups will receive riboflavin
Interventions
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VEGA UV-A Illumination System
Only subjects assigned to the treatment group will receive treatment with the UV Light
Riboflavin
Both treatment and sham groups will receive riboflavin
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Ectasia
* Presence of central or inferior steepening
* Topography consistent with ectasia
* BSCVA 20/20 or worse
* If contact lens wearer; removal of contact lenses for required period of time
* Signed informed consent
* Willingness and ability to comply with schedule for follow-up visits
Exclusion Criteria
* History of chemical injury or delayed epithelial healing
* A known sensitivity to study medications
* Nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests
* A condition that would interfere with or prolong epithelial healing
* Presence or history of any other condition or finding that makes the patient unsuitable for treatment
18 Years
ALL
No
Sponsors
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Topcon Medical Systems, Inc.
INDUSTRY
Responsible Party
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Locations
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Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States
Woolfson Eye Institute
Atlanta, Georgia, United States
Minnesota Eye Consultants, P.A.
Bloomington, Minnesota, United States
Laser and Corneal Surgery Assoc. PC
New York, New York, United States
Mt. Sinai Hospital
New York, New York, United States
Pamel Vision & Laser Group
New York, New York, United States
Cleveland Clinic-Cole Eye Institute
Cleveland, Ohio, United States
The Ohio State University College of Medicine
Columbus, Ohio, United States
ReVision Advanced Laser Eye Center
Columbus, Ohio, United States
Dell Laser Consultants
Austin, Texas, United States
Slade & Baker Vision
Houston, Texas, United States
The Eye Institute of Utah
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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CXL-002
Identifier Type: -
Identifier Source: org_study_id
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