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Safety and Effectiveness Study of the VEGA UV-A System for Cross-linking in Eyes With Keratoconus and 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.
 
ClinicalTrials.gov Identifier: NCT01398852
Recruitment Status : Terminated
First Posted : July 21, 2011
Results First Posted : March 4, 2013
Last Update Posted : January 4, 2022
Sponsor:
Information provided by (Responsible Party):
Topcon Corporation ( Topcon Medical Systems, Inc. )

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Keratoconus and Ectasia Drug: Riboflavin Device: VEGA UV-A Illumination System Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Study Start Date : December 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Riboflavin

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Corneal Curvature [ Time Frame: 24 MO ]

Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01398852


Locations
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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
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
ReVision Advanced Laser Eye Center
Columbus, Ohio, United States, 43240
OSU Department of Ophthalomogy
Columbus, Ohio, United States
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
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Responsible Party: Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01398852    
Other Study ID Numbers: CXL-003
First Posted: July 21, 2011    Key Record Dates
Results First Posted: March 4, 2013
Last Update Posted: January 4, 2022
Last Verified: December 2012
Additional relevant MeSH terms:
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Keratoconus
Dilatation, Pathologic
Corneal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Riboflavin
 Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents