Safety Study of the VEGA UV-A System to Treat Ectasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01398839
Recruitment Status : Terminated
First Posted : July 21, 2011
Results First Posted : March 4, 2013
Last Update Posted : February 1, 2017
Information provided by (Responsible Party):
Topcon Medical Systems, Inc.

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.

Condition or disease Intervention/treatment Phase
Ectasia Device: VEGA UV-A Illumination System Drug: Riboflavin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2010
Actual Primary Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Riboflavin
U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Sham Control Drug: Riboflavin
Both treatment and sham groups will receive riboflavin
Experimental: CXL Treatment Device: VEGA UV-A Illumination System
Only subjects assigned to the treatment group will receive treatment with the UV Light
Drug: Riboflavin
Both treatment and sham groups will receive riboflavin

Primary Outcome Measures :
  1. Changes in Corneal Curvature [ Time Frame: 6 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01398839

United States, Arizona
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States
United States, Georgia
Woolfson Eye Institute
Atlanta, Georgia, United States
United States, Minnesota
Minnesota Eye Consultants, P.A.
Bloomington, Minnesota, United States, 55431
United States, New York
Laser and Corneal Surgery Assoc. PC
New York, New York, United States, 10022
Mt. Sinai Hospital
New York, New York, United States
Pamel Vision & Laser Group
New York, New York, United States
United States, Ohio
Cleveland Clinic-Cole Eye Institute
Cleveland, Ohio, United States, 44195
The Ohio State University College of Medicine
Columbus, Ohio, United States, 43212
ReVision Advanced Laser Eye Center
Columbus, Ohio, United States, 43240
United States, Texas
Dell Laser Consultants
Austin, Texas, United States
Slade & Baker Vision
Houston, Texas, United States
United States, Utah
The Eye Institute of Utah
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Topcon Medical Systems, Inc.

Responsible Party: Topcon Medical Systems, Inc. Identifier: NCT01398839     History of Changes
Other Study ID Numbers: CXL-002
First Posted: July 21, 2011    Key Record Dates
Results First Posted: March 4, 2013
Last Update Posted: February 1, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Dilatation, Pathologic
Pathological Conditions, Anatomical
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents