Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
130 participants
INTERVENTIONAL
2007-12-31
2011-11-30
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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Corneal Collagen Cross-linking (CXL) Treatment Group
riboflavin ophthalmic solution and UVA irradiation
riboflavin ophthalmic solution
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
UVA Irradiation
UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
Control Group
riboflavin opthalmic solution without UVA irradiation
riboflavin ophthalmic solution
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
Interventions
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riboflavin ophthalmic solution
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
UVA Irradiation
UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented ectasia on Pentacam or topography map
* BSCVA worse than 20/20
* Must complete all study visits
Exclusion Criteria
* History of corneal melt or corneal dystrophy
14 Years
ALL
No
Sponsors
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Glaukos Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Hersh, MD
Role: PRINCIPAL_INVESTIGATOR
Cornea and Laser Eye Institute
Locations
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Shiley Eye Center
La Jolla, California, United States
Gordon -Weiss Vision Institute
San Diego, California, United States
Center for Excellence in Eye Care
Miami, Florida, United States
Price Vision Group
Indianapolis, Indiana, United States
Durrie Vision
Kansas City, Kansas, United States
Wilmer Eye Institute at Johns Hopkins University
Baltimore, Maryland, United States
Minnesota Eye Consultants
Minneapolis, Minnesota, United States
Cornea & Laser Eye Institute; Hersh Vision Group
Teaneck, New Jersey, United States
Edward Harkness Eye Institute at Columbia University Medical Center
New York, New York, United States
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States
Countries
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References
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Greenstein SA, Fry KL, Hersh PS. Effect of topographic cone location on outcomes of corneal collagen cross-linking for keratoconus and corneal ectasia. J Refract Surg. 2012 Jun;28(6):397-405. doi: 10.3928/1081597X-20120518-02.
Other Identifiers
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UVX-003
Identifier Type: -
Identifier Source: org_study_id
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