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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

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
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • Minnesota Eye Consultants, P.A.
    • New York
      • New York, New York, United States, 10022
        • Laser and Corneal Surgery Assoc. PC
      • New York, New York, United States
        • Mt. Sinai Hospital
      • New York, New York, United States
        • Pamel Vision & Laser Group
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic-Cole Eye Institute
      • Columbus, Ohio, United States, 43212
        • The Ohio State University College of Medicine
      • Columbus, Ohio, United States, 43240
        • ReVision Advanced Laser Eye Center
    • Texas
      • Austin, Texas, United States
        • Dell Laser Consultants
      • Houston, Texas, United States
        • Slade & Baker Vision
    • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
Sham Comparator: Sham Control
Drug: Riboflavin
Both treatment and sham groups will receive riboflavin
Experimental: CXL Treatment
Drug: Riboflavin
Both treatment and sham groups will receive riboflavin
Device: VEGA UV-A Illumination System
Only subjects assigned to the treatment group will receive treatment with the UV Light

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes 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

December 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 10, 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-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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