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

June 6, 2022 updated by: Topcon Medical Systems, Inc.

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Barnet Dulaney Perkins Eye Center
    • Georgia
      • Atlanta, Georgia, United States
        • Woolfson Eye Institute
    • Massachusetts
      • Boston, Massachusetts, United States
        • Massachusetts Eye and Ear Infirmary
    • Minnesota
      • Bloomington, Minnesota, United States
        • Minnesota Eye Consultants
    • New York
      • New York, New York, United States, 10022
        • Laser and Corneal Surgery Assoc. PC
      • New York, New York, United States
        • Pamel Vision & Laser Group
      • New York, New York, United States
        • Mt Sinai Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic-Cole Eye Institute
      • Columbus, Ohio, United States, 43240
        • ReVision Advanced Laser Eye Center
      • Columbus, Ohio, United States
        • OSU Department of Ophthalomogy
    • Texas
      • Austin, Texas, United States
        • Dell Laser Consultants
      • Houston, Texas, United States
        • Slade and Baker Vision Center
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • The Eye Institute of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Corneal Curvature
Time Frame: 24 MO
24 MO

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Topcon Medical Systems, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 11, 2011

First Submitted That Met QC Criteria

July 19, 2011

First Posted (Estimate)

July 21, 2011

Study Record Updates

Last Update Posted (Actual)

June 29, 2022

Last Update Submitted That Met QC Criteria

June 6, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CXL-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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