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

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: NCT01190306
Recruitment Status : Terminated (The sponsor terminated the study prior to data analysis for financial reasons.)
First Posted : August 27, 2010
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 keratoconus.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of the VEGA UV-A System for Corneal Collagen Cross-Linking in Eyes With Keratoconus
Study Start Date : August 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Riboflavin

Arm Intervention/treatment
Experimental: CXL Treatment
Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
Device: The VEGA UV-A Illumination System
This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area

Drug: Riboflavin
Riboflavin is a solution that will be delivered to the treatment area

Active Comparator: Sham Control
Eyes in the control group will be treated with riboflavin only.
Drug: Riboflavin
Riboflavin is a solution that will be delivered to the treatment area

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 12 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

Exclusion Criteria:

  • 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.

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): NCT01190306

United States, Arizona
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States, 85016
United States, Georgia
Woolfson Eye Institute
Atlanta, Georgia, United States, 30328
United States, Minnesota
Minnesota Eye Consultants
Bloomington, Minnesota, United States, 55431
United States, New York
Pamel Vision & Laser Group
New York, New York, United States, 10021
Mt. Sinai Hospital
New York, New York, United States, 10029
United States, Ohio
OSU Department of Ophthalmoloty
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, 78746
Slade & Baker Vision Center
Houston, Texas, United States, 77027
Sponsors and Collaborators
Topcon Medical Systems, Inc.

Responsible Party: Topcon Medical Systems, Inc. Identifier: NCT01190306     History of Changes
Other Study ID Numbers: CXL-001
First Posted: August 27, 2010    Key Record Dates
Results First Posted: March 4, 2013
Last Update Posted: February 1, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Corneal Diseases
Eye Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents