Safety Study of the VEGA UV-A System to Treat Keratoconus
This study has been terminated.
(The sponsor terminated the study prior to data analysis for financial reasons.)
Sponsor:
Topcon Medical Systems, Inc.
Information provided by (Responsible Party):
Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01190306
First received: August 25, 2010
Last updated: January 28, 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 keratoconus.
| Condition | Intervention | Phase |
|---|---|---|
|
Keratoconus |
Device: The 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 |
| Official Title: | Safety and Effectiveness of the VEGA UV-A System for Corneal Collagen Cross-Linking in Eyes With Keratoconus |
Resource links provided by NLM:
Further study details as provided by Topcon Medical Systems, Inc.:
Primary Outcome Measures:
- Changes in Corneal Curvature [ Time Frame: 6MO ] [ Designated as safety issue: Yes ]
- Change in Corneal Curvature. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
| Enrollment: | 118 |
| Study Start Date: | August 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CXL Treatment
Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
|
Device: The VEGA UV-A Illumination System
This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area
Drug: Riboflavin
Riboflavin is a solution that will be delivered to the treatment area
|
|
Active Comparator: Sham Control
Eyes in the control group will be treated with riboflavin only.
|
Drug: Riboflavin
Riboflavin is a solution that will be delivered to the treatment area
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 12 years of age or older
- Having a diagnosis of keratoconus
- Presence of central or inferior steepening
- Topography consistent with keratoconus
- Presence of one or more slit lamp or retinoscopy findings associated with keratoconus
- Contact lens wearers only:Removal of contact lenses for the required period of time
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
Exclusion Criteria:
- For keratoconus, a history of previous corneal surgery or the insertion of Intacs in the eye to be treated
- Corneal pachymetry ≤ 400 microns
- Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
- A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
- Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests
- A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
- Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190306
Locations
| United States, Arizona | |
| Barnet Dulaney Perkins Eye Center | |
| Phoenix, Arizona, United States, 85016 | |
| United States, Georgia | |
| Woolfson Eye Institute | |
| Atlanta, Georgia, United States, 30328 | |
| United States, Minnesota | |
| Minnesota Eye Consultants | |
| Bloomington, Minnesota, United States, 55431 | |
| United States, New York | |
| Pamel Vision & Laser Group | |
| New York, New York, United States, 10021 | |
| Mt. Sinai Hospital | |
| New York, New York, United States, 10029 | |
| United States, Ohio | |
| OSU Department of Ophthalmoloty | |
| Columbus, Ohio, United States, 43212 | |
| Revision Advanced Laser Eye Center | |
| Columbus, Ohio, United States, 43240 | |
| United States, Texas | |
| Dell Laser Consultants | |
| Austin, Texas, United States, 78746 | |
| Slade & Baker Vision Center | |
| Houston, Texas, United States, 77027 | |
Sponsors and Collaborators
Topcon Medical Systems, Inc.
More Information
No publications provided
| Responsible Party: | Topcon Medical Systems, Inc. |
| ClinicalTrials.gov Identifier: | NCT01190306 History of Changes |
| Other Study ID Numbers: | CXL-001 |
| Study First Received: | August 25, 2010 |
| Results First Received: | December 13, 2012 |
| Last Updated: | January 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Keratoconus Corneal Diseases Eye Diseases 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 16, 2013