Status:
TERMINATED
Safety Study of the VEGA UV-A System to Treat Ectasia
Lead Sponsor:
Topcon Medical Systems, Inc.
Conditions:
Ectasia
Eligibility:
All Genders
18+ 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 ectasia.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01398839
Start Date
December 1 2010
End Date
July 1 2012
Last Update
June 29 2022
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States
2
Woolfson Eye Institute
Atlanta, Georgia, United States
3
Minnesota Eye Consultants, P.A.
Bloomington, Minnesota, United States, 55431
4
Laser and Corneal Surgery Assoc. PC
New York, New York, United States, 10022