Status:
TERMINATED
Safety and Effectiveness Study of the VEGA UV-A System for Cross-linking in Eyes With Keratoconus and Ectasia
Lead Sponsor:
Topcon Medical Systems, Inc.
Conditions:
Keratoconus and Ectasia
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 12 years of age or older
- Diagnosis of Keratoconus or Ectasia
- Central or Inferior steepening on the Pentacam map
- Topography consistent with Keratoconus or Ectasia
- BSCVA 20/20 or worse
- Removal of contact lenses for 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
- Corneal pachymentry equal to or greater and 400
- Previous ocular condition in the eyes to be treated that may predispose the eye for future complications
- A history of chemical injury or delayed healing
- Pregnancy
- A known sensitivity to the study medications
- Nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests
- Presence or history of any other condition or finding that makes the patient unsuitable as a candidate
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01398852
Start Date
December 1 2010
End Date
July 1 2012
Last Update
June 29 2022
Active Locations (13)
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1
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States
2
Woolfson Eye Institute
Atlanta, Georgia, United States
3
Massachusetts Eye And Ear Infirmary
Boston, Massachusetts, United States
4
Minnesota Eye Consultants
Bloomington, Minnesota, United States