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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01398839
First received: July 10, 2011
Last updated: January 25, 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 ectasia.


Condition Intervention Phase
Ectasia
Device: 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

Resource links provided by NLM:


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

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

Enrollment: 103
Study Start Date: December 2010
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398839

Locations
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
Pamel Vision & Laser Group
New York, New York, United States
Mt. Sinai Hospital
New York, New York, United States
Laser and Corneal Surgery Assoc. PC
New York, New York, United States, 10022
United States, Ohio
Cleveland Clinic-Cole Eye Institute
Cleveland, Ohio, United States, 44195
ReVision Advanced Laser Eye Center
Columbus, Ohio, United States, 43240
The Ohio State University College of Medicine
Columbus, Ohio, United States, 43212
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.
  More Information

No publications provided

Responsible Party: Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01398839     History of Changes
Other Study ID Numbers: CXL-002
Study First Received: July 10, 2011
Results First Received: December 13, 2012
Last Updated: January 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dilatation, Pathologic
Pathological Conditions, Anatomical
Riboflavin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014