Back to resultsSafety Study of the VEGA UV-A System to Treat Ectasia
Primary Purpose
Ectasia
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
VEGA UV-A Illumination System
Riboflavin
Sponsored by
About this trial
This is an interventional treatment trial for Ectasia
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
Sites / Locations
- Barnet Dulaney Perkins Eye Center
- Woolfson Eye Institute
- Minnesota Eye Consultants, P.A.
- Laser and Corneal Surgery Assoc. PC
- Mt. Sinai Hospital
- Pamel Vision & Laser Group
- Cleveland Clinic-Cole Eye Institute
- The Ohio State University College of Medicine
- ReVision Advanced Laser Eye Center
- Dell Laser Consultants
- Slade & Baker Vision
- The Eye Institute of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Sham Control
CXL Treatment
Arm Description
Outcomes
Primary Outcome Measures
Changes in Corneal Curvature
Secondary Outcome Measures
Full Information
NCT ID
NCT01398839
First Posted
July 10, 2011
Last Updated
June 6, 2022
Sponsor
Topcon Medical Systems, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01398839
Brief Title
Safety Study of the VEGA UV-A System to Treat Ectasia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Topcon Medical Systems, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ectasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham Control
Arm Type
Sham Comparator
Arm Title
CXL Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
VEGA UV-A Illumination System
Intervention Description
Only subjects assigned to the treatment group will receive treatment with the UV Light
Intervention Type
Drug
Intervention Name(s)
Riboflavin
Intervention Description
Both treatment and sham groups will receive riboflavin
Primary Outcome Measure Information:
Title
Changes in Corneal Curvature
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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
Facility Information:
Facility Name
Barnet Dulaney Perkins Eye Center
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Woolfson Eye Institute
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Minnesota Eye Consultants, P.A.
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
Laser and Corneal Surgery Assoc. PC
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Mt. Sinai Hospital
City
New York
State/Province
New York
Country
United States
Facility Name
Pamel Vision & Laser Group
City
New York
State/Province
New York
Country
United States
Facility Name
Cleveland Clinic-Cole Eye Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University College of Medicine
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
ReVision Advanced Laser Eye Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43240
Country
United States
Facility Name
Dell Laser Consultants
City
Austin
State/Province
Texas
Country
United States
Facility Name
Slade & Baker Vision
City
Houston
State/Province
Texas
Country
United States
Facility Name
The Eye Institute of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study of the VEGA UV-A System to Treat Ectasia
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