Study Stopped
The sponsor terminated the study prior to data analysis for financial reasons.
Safety Study of the VEGA UV-A System to Treat Keratoconus
Safety and Effectiveness of the VEGA UV-A System for Corneal Collagen Cross-Linking in Eyes With Keratoconus
1 other identifier
interventional
127
1 country
9
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 keratoconus.
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 Aug 2010
Shorter than P25 for phase_3
9 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
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 25, 2010
CompletedFirst Posted
Study publicly available on registry
August 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
March 4, 2013
CompletedJuly 12, 2022
July 1, 2022
1.3 years
August 25, 2010
December 13, 2012
July 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Corneal Curvature.
6 Months
Study Arms (2)
CXL Treatment
EXPERIMENTALEyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
Sham Control
ACTIVE COMPARATOREyes in the control group will be treated with riboflavin only.
Interventions
This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area
Riboflavin is a solution that will be delivered to the treatment area
Eligibility Criteria
You may qualify if:
- years of age or older
- Having a diagnosis of keratoconus
- Presence of central or inferior steepening
- Topography consistent with keratoconus
- Presence of one or more slit lamp or retinoscopy findings associated with keratoconus
- Contact lens wearers only:Removal of contact lenses for the required period of time
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
You may not qualify if:
- For keratoconus, a history of previous corneal surgery or the insertion of Intacs in the eye to be treated
- Corneal pachymetry ≤ 400 microns
- Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
- A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
- Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests
- A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
- Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, 85016, United States
Woolfson Eye Institute
Atlanta, Georgia, 30328, United States
Minnesota Eye Consultants
Bloomington, Minnesota, 55431, United States
Pamel Vision & Laser Group
New York, New York, 10021, United States
Mt. Sinai Hospital
New York, New York, 10029, United States
OSU Department of Ophthalmoloty
Columbus, Ohio, 43212, United States
Revision Advanced Laser Eye Center
Columbus, Ohio, 43240, United States
Dell Laser Consultants
Austin, Texas, 78746, United States
Slade & Baker Vision Center
Houston, Texas, 77027, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Gibson
- Organization
- Topcon Medical Systems
Publication Agreements
- PI is Sponsor Employee
- No
- 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
August 25, 2010
First Posted
August 27, 2010
Study Start
August 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
July 12, 2022
Results First Posted
March 4, 2013
Record last verified: 2022-07