Ectasia Clinical Trial
NCT number | NCT01398839 |
Other study ID # | CXL-002 |
Secondary ID | |
Status | Terminated |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | December 2010 |
Est. completion date | July 2012 |
Verified date | June 2022 |
Source | Topcon Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL) when used to treat ectasia.
Status | Terminated |
Enrollment | 103 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 Years of age or older - 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: - Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Woolfson Eye Institute | Atlanta | Georgia |
United States | Dell Laser Consultants | Austin | Texas |
United States | Minnesota Eye Consultants, P.A. | Bloomington | Minnesota |
United States | Cleveland Clinic-Cole Eye Institute | Cleveland | Ohio |
United States | ReVision Advanced Laser Eye Center | Columbus | Ohio |
United States | The Ohio State University College of Medicine | Columbus | Ohio |
United States | Slade & Baker Vision | Houston | Texas |
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 | Barnet Dulaney Perkins Eye Center | Phoenix | Arizona |
United States | The Eye Institute of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Topcon Medical Systems, Inc. |
United States,
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---|---|---|---|---|
Primary | Changes in Corneal Curvature | 6 Months |
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