Status:
TERMINATED
Safety Study of the VEGA UV-A System to Treat Keratoconus
Lead Sponsor:
Topcon Medical Systems, Inc.
Conditions:
Keratoconus
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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 keratoconus.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT01190306
Start Date
August 1 2010
End Date
December 1 2011
Last Update
July 12 2022
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States, 85016
2
Woolfson Eye Institute
Atlanta, Georgia, United States, 30328
3
Minnesota Eye Consultants
Bloomington, Minnesota, United States, 55431
4
Pamel Vision & Laser Group
New York, New York, United States, 10021