Unknown statusInterventionalPhase 2Updated Mar 29, 2011
Safety Study of the VEGA UV-A System to Treat Ectasia | NCT01398839 | Trialant
TerminatedInterventionalPhase 3Updated Jun 29, 2022
Safety Study of the VEGA UV-A System to Treat Ectasia
ClinicalTrials.gov ID
NCT01398839
Lead Sponsor
Topcon Medical Systems, Inc.INDUSTRY
Overall Status
Terminated
Study Type
Interventional
Phase
Phase 3
Enrollment
103Actual
Last Update Posted
Jun 29, 2022Actual
Start Date
Dec 2010
Primary Completion Date
Jul 2012Actual
Completion Date
Jul 2012Actual
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.
Ectasia
VEGA UV-A Illumination System
Riboflavin
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility 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