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

July 5, 2022 updated by: Topcon Medical Systems, Inc.

Safety and Effectiveness of the VEGA UV-A System for Corneal Collagen Cross-Linking in Eyes With Keratoconus

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

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, 85016
        • Barnet Dulaney Perkins Eye Center
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Woolfson Eye Institute
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • Minnesota Eye Consultants
    • New York
      • New York, New York, United States, 10021
        • Pamel Vision & Laser Group
      • New York, New York, United States, 10029
        • Mt. Sinai Hospital
    • Ohio
      • Columbus, Ohio, United States, 43240
        • ReVision Advanced Laser Eye Center
      • Columbus, Ohio, United States, 43212
        • OSU Department of Ophthalmoloty
    • Texas
      • Austin, Texas, United States, 78746
        • Dell Laser Consultants
      • Houston, Texas, United States, 77027
        • Slade & Baker Vision Center

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
  • 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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Corneal Curvature.
Time Frame: 6 Months
6 Months

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

August 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 25, 2010

First Submitted That Met QC Criteria

August 25, 2010

First Posted (Estimate)

August 27, 2010

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 5, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CXL-001

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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