Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas
NCT ID: NCT03029104
Last Updated: 2022-01-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
2228 participants
INTERVENTIONAL
2016-12-21
2020-12-27
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
SINGLE
Study Groups
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Group 1
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device
CXLO Corneal Strengthening Solution
Group 2
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device
CXLO Corneal Strengthening Solution
Group 3
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device
CXLO Corneal Strengthening Solution
Interventions
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CXLO Corneal Strengthening Solution and UVA Illumination Device
CXLO Corneal Strengthening Solution
Eligibility Criteria
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Inclusion Criteria
1. Keratoconus
2. Forme fruste keratoconus
3. Post-LASIK ectasia
4. Pellucid marginal degeneration
5. Forme fruste pellucid marginal degeneration
6. Diurnal fluctuation post-radial keratotomy
7. Terrien's marginal degeneration
Exclusion Criteria
2. Contraindications or hypersensitivities to any study medications or their components.
3. Pregnancy or breastfeeding.
4. Any history of herpes simplex corneal disease in an eye to be treated.
5. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.
6. Inability to cooperate with diagnostic tests.
7. Enrollment in another ophthalmic clinical trial.
8 Years
ALL
No
Sponsors
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Cxlusa
INDUSTRY
Responsible Party
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Principal Investigators
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Gregg J Berdy, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
Ophthalmology Associates, St. Louis, MO
Locations
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Schwartz Laser Eye Center
Scottsdale, Arizona, United States
Goodman Eye Center
San Francisco, California, United States
Cornea Consultants of Colorado
Littleton, Colorado, United States
Woolfson Eye Institute
Atlanta, Georgia, United States
Chicago Cornea Consultants
Chicago, Illinois, United States
Chicago Cornea Consultants, Ltd.
Hoffman Estates, Illinois, United States
Ophthalmology Associates
St Louis, Missouri, United States
Cleveland Eye Clinic
Brecksville, Ohio, United States
Cornea Associates of Texas
Dallas, Texas, United States
Countries
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References
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Epstein RJ, Belin MW, Gravemann D, Littner R, Rubinfeld RS. EpiSmart Crosslinking for Keratoconus: A Phase 2 Study. Cornea. 2023 Jul 1;42(7):858-866. doi: 10.1097/ICO.0000000000003136. Epub 2022 Sep 28.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CXL-005
Identifier Type: -
Identifier Source: org_study_id
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