Safety Study of the VEGA UV-A System to Treat Ectasia
This study has been terminated.
Sponsor:
Topcon Medical Systems, Inc.
Information provided by (Responsible Party):
Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01398839
First received: July 10, 2011
Last updated: January 25, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ectasia |
Device: VEGA UV-A Illumination System Drug: Riboflavin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Topcon Medical Systems, Inc.:
Primary Outcome Measures:
- Changes in Corneal Curvature [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
| Enrollment: | 103 |
| Study Start Date: | December 2010 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Sham Comparator: Sham Control |
Drug: Riboflavin
Both treatment and sham groups will receive riboflavin
|
| Experimental: CXL Treatment |
Device: VEGA UV-A Illumination System
Only subjects assigned to the treatment group will receive treatment with the UV Light
Drug: Riboflavin
Both treatment and sham groups will receive riboflavin
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398839
Locations
| United States, Arizona | |
| Barnet Dulaney Perkins Eye Center | |
| Phoenix, Arizona, United States | |
| United States, Georgia | |
| Woolfson Eye Institute | |
| Atlanta, Georgia, United States | |
| United States, Minnesota | |
| Minnesota Eye Consultants, P.A. | |
| Bloomington, Minnesota, United States, 55431 | |
| United States, New York | |
| Pamel Vision & Laser Group | |
| New York, New York, United States | |
| Mt. Sinai Hospital | |
| New York, New York, United States | |
| Laser and Corneal Surgery Assoc. PC | |
| New York, New York, United States, 10022 | |
| United States, Ohio | |
| Cleveland Clinic-Cole Eye Institute | |
| Cleveland, Ohio, United States, 44195 | |
| ReVision Advanced Laser Eye Center | |
| Columbus, Ohio, United States, 43240 | |
| The Ohio State University College of Medicine | |
| Columbus, Ohio, United States, 43212 | |
| United States, Texas | |
| Dell Laser Consultants | |
| Austin, Texas, United States | |
| Slade & Baker Vision | |
| Houston, Texas, United States | |
| United States, Utah | |
| The Eye Institute of Utah | |
| Salt Lake City, Utah, United States, 84107 | |
Sponsors and Collaborators
Topcon Medical Systems, Inc.
More Information
No publications provided
| Responsible Party: | Topcon Medical Systems, Inc. |
| ClinicalTrials.gov Identifier: | NCT01398839 History of Changes |
| Other Study ID Numbers: | CXL-002 |
| Study First Received: | July 10, 2011 |
| Results First Received: | December 13, 2012 |
| Last Updated: | January 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Dilatation, Pathologic Pathological Conditions, Anatomical Riboflavin Photosensitizing Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions |
Dermatologic Agents Therapeutic Uses Vitamin B Complex Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013