Safety Study of the VEGA UV-A System to Treat Ectasia
1 other identifier
interventional
103
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2010
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 10, 2011
CompletedFirst Posted
Study publicly available on registry
July 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
March 4, 2013
CompletedJune 29, 2022
June 1, 2022
1.6 years
July 10, 2011
December 13, 2012
June 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in Corneal Curvature
6 Months
Study Arms (2)
Sham Control
SHAM COMPARATORCXL Treatment
EXPERIMENTALInterventions
Only subjects assigned to the treatment group will receive treatment with the UV Light
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States
Woolfson Eye Institute
Atlanta, Georgia, United States
Minnesota Eye Consultants, P.A.
Bloomington, Minnesota, 55431, United States
Laser and Corneal Surgery Assoc. PC
New York, New York, 10022, United States
Mt. Sinai Hospital
New York, New York, United States
Pamel Vision & Laser Group
New York, New York, United States
Cleveland Clinic-Cole Eye Institute
Cleveland, Ohio, 44195, United States
The Ohio State University College of Medicine
Columbus, Ohio, 43212, United States
ReVision Advanced Laser Eye Center
Columbus, Ohio, 43240, United States
Dell Laser Consultants
Austin, Texas, United States
Slade & Baker Vision
Houston, Texas, United States
The Eye Institute of Utah
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bob Gibson
- Organization
- Topcon Medical Systems
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2011
First Posted
July 21, 2011
Study Start
December 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
June 29, 2022
Results First Posted
March 4, 2013
Record last verified: 2022-06