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

This study has been terminated.
(The sponsor terminated the study prior to data analysis for financial reasons.)
Sponsor:
Information provided by (Responsible Party):
Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01190306
First received: August 25, 2010
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Keratoconus
Device: The VEGA UV-A Illumination System
Drug: Riboflavin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Topcon Medical Systems, Inc.:

Primary Outcome Measures:
  • Changes in Corneal Curvature [ Time Frame: 6MO ] [ Designated as safety issue: Yes ]
  • Change in Corneal Curvature. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Enrollment: 118
Study Start Date: August 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190306

Locations
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.
  More Information

No publications provided

Responsible Party: Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01190306     History of Changes
Other Study ID Numbers: CXL-001
Study First Received: August 25, 2010
Results First Received: December 13, 2012
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases
Riboflavin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 01, 2014