Collagen Cross-Linking for Keratoconus/Ectasia With and Without Intacs
NCT ID: NCT01081561
Last Updated: 2018-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
600 participants
INTERVENTIONAL
2009-01-21
2021-06-30
Brief Summary
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Detailed Description
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These treatments have been widely used outside of the United States for the treatment of progressive keratoconus. Corneal Collagen Cross linking was recently approved in the United States for the treatment of progressive keratoconus. We will attempt to study 600 patients total. 300 patients will be assigned to cross linking only while another 300 will be assigned to cross linking and INTACS. Once adequate number of study subjects have been recruited data will be analyzed to determine which treatment is more effective. The following parameters from Topography, OCT and Tomography will be studied(these are Max K(pentacam) Kvalue(Tomey Topography)I-Svalue(Tomey Topography Astigmatism(Tomey Topography) and Min OCT(corneal pachymetry) any one of these metrics that achieve a value of 1 or more will be included in the analysis since the cornea is so irregular that values less than one could be artifact
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cross-linking
Corneal collagen cross-linking with riboflavin and UVA light
Riboflavin
Removal of the epithelium, riboflavin drops every 2 minutes for 30 minutes follow by UV light radiation and addition riboflavin drops every 2 minutes for 30 minutes. Some subjects will be randomized to recieve INTACS prior to treatment with riboflavin.
Cross-linking plus INTACS
Corneal collagen cross-linking with riboflavin and UVA light plus INTACS
Riboflavin
Removal of the epithelium, riboflavin drops every 2 minutes for 30 minutes follow by UV light radiation and addition riboflavin drops every 2 minutes for 30 minutes. Some subjects will be randomized to recieve INTACS prior to treatment with riboflavin.
Interventions
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Riboflavin
Removal of the epithelium, riboflavin drops every 2 minutes for 30 minutes follow by UV light radiation and addition riboflavin drops every 2 minutes for 30 minutes. Some subjects will be randomized to recieve INTACS prior to treatment with riboflavin.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* K readings greater than 60D
* Central corneal scarring
21 Years
65 Years
ALL
No
Sponsors
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Yaron S. Rabinowitz M.D.
OTHER
Responsible Party
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Yaron S. Rabinowitz M.D.
Yaron S Rabinowitz M.D.
Principal Investigators
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Yaron S Rabinowitz, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cornea Genetic Eye Institute
Ezra Maguen, M.D.
Role: PRINCIPAL_INVESTIGATOR
american eye institute
Yuri Oleynikov, M.D. PhD
Role: PRINCIPAL_INVESTIGATOR
Cornea Genetic Eye Institute
James Salz, M.D.
Role: PRINCIPAL_INVESTIGATOR
Laser Eye Associates
Ronald Gaster, MD
Role: PRINCIPAL_INVESTIGATOR
Cornea Eye Institute, Beverly Hills
Locations
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Cornea Eye Institute, 50 North La Cienaga Blvd, #340
Beverly Hills, California, United States
Countries
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Other Identifiers
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#20090780
Identifier Type: -
Identifier Source: org_study_id
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