Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety and Effectiveness Study of the VEGA UV-A System for Cross-linking in Eyes With Keratoconus and Ectasia

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01398852
First received: July 11, 2011
Last updated: January 25, 2013
Last verified: December 2012
  Purpose

The purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.


Condition Intervention Phase
Keratoconus and Ectasia
Drug: Riboflavin
Device: VEGA UV-A Illumination System
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Long Term Safety and Effectiveness of the VEGA UV-A System for Corneal Collagen Cross-Linking in Eyes With Keratoconus or Post-Refractive Corneal Ectasia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Changes in Corneal Curvature [ Time Frame: 24 MO ] [ Designated as safety issue: Yes ]

Enrollment: 500
Study Start Date: December 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CXL Treatment
All eyes to be treated with riboflavin and UV light
Drug: Riboflavin
Riboflavin is a solution that will be delivered to the treatment area
Device: VEGA UV-A Illumination System
This is a portable electronic device designed to deliver a dose of UV-A light 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
  • Diagnosis of Keratoconus or Ectasia
  • Central or Inferior steepening on the Pentacam map
  • Topography consistent with Keratoconus or Ectasia
  • BSCVA 20/20 or worse
  • Removal of contact lenses for 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
  • Corneal pachymentry equal to or greater and 400
  • Previous ocular condition in the eyes to be treated that may predispose the eye for future complications
  • A history of chemical injury or delayed healing
  • Pregnancy
  • A known sensitivity to the study medications
  • Nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests
  • Presence or history of any other condition or finding that makes the patient unsuitable as a candidate
  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: NCT01398852

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, Massachusetts
Massachusetts Eye And Ear Infirmary
Boston, Massachusetts, United States
United States, Minnesota
Minnesota Eye Consultants
Bloomington, Minnesota, United States
United States, New York
Mt Sinai Hospital
New York, New York, United States
Pamel Vision & Laser Group
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
OSU Department of Ophthalomogy
Columbus, Ohio, United States
ReVision Advanced Laser Eye Center
Columbus, Ohio, United States, 43240
United States, Texas
Dell Laser Consultants
Austin, Texas, United States
Slade and Baker Vision Center
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: NCT01398852     History of Changes
Other Study ID Numbers: CXL-003
Study First Received: July 11, 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
Keratoconus
Corneal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Riboflavin
Dermatologic Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Photosensitizing Agents
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 19, 2014