Safety Study of the VEGA UV-A System to Treat Ectasia
- Conditions
- Ectasia
- Interventions
- Device: VEGA UV-A Illumination SystemDrug: Riboflavin
- Registration Number
- NCT01398839
- Lead Sponsor
- Topcon Medical Systems, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 103
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CXL Treatment VEGA UV-A Illumination System - Sham Control Riboflavin - CXL Treatment Riboflavin -
- Primary Outcome Measures
Name Time Method Changes in Corneal Curvature 6 Months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Barnet Dulaney Perkins Eye Center
🇺🇸Phoenix, Arizona, United States
Slade & Baker Vision
🇺🇸Houston, Texas, United States
The Eye Institute of Utah
🇺🇸Salt Lake City, Utah, United States
Woolfson Eye Institute
🇺🇸Atlanta, Georgia, United States
Cleveland Clinic-Cole Eye Institute
🇺🇸Cleveland, Ohio, United States
ReVision Advanced Laser Eye Center
🇺🇸Columbus, Ohio, 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
The Ohio State University College of Medicine
🇺🇸Columbus, Ohio, United States
Pamel Vision & Laser Group
🇺🇸New York, New York, United States
Dell Laser Consultants
🇺🇸Austin, Texas, United States