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

Primary Purpose

Keratoconus

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
The VEGA UV-A Illumination System
Riboflavin
Sponsored by
Topcon Medical Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Barnet Dulaney Perkins Eye Center
  • Woolfson Eye Institute
  • Minnesota Eye Consultants
  • Pamel Vision & Laser Group
  • Mt. Sinai Hospital
  • OSU Department of Ophthalmoloty
  • Revision Advanced Laser Eye Center
  • Dell Laser Consultants
  • Slade & Baker Vision Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CXL Treatment

Sham Control

Arm Description

Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.

Eyes in the control group will be treated with riboflavin only.

Outcomes

Primary Outcome Measures

Change in Corneal Curvature.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2010
Last Updated
July 5, 2022
Sponsor
Topcon Medical Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01190306
Brief Title
Safety Study of the VEGA UV-A System to Treat Keratoconus
Official Title
Safety and Effectiveness of the VEGA UV-A System for Corneal Collagen Cross-Linking in Eyes With Keratoconus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
The sponsor terminated the study prior to data analysis for financial reasons.
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Topcon Medical Systems, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CXL Treatment
Arm Type
Experimental
Arm Description
Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
Arm Title
Sham Control
Arm Type
Active Comparator
Arm Description
Eyes in the control group will be treated with riboflavin only.
Intervention Type
Device
Intervention Name(s)
The VEGA UV-A Illumination System
Intervention Description
This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area
Intervention Type
Drug
Intervention Name(s)
Riboflavin
Intervention Description
Riboflavin is a solution that will be delivered to the treatment area
Primary Outcome Measure Information:
Title
Change in Corneal Curvature.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Barnet Dulaney Perkins Eye Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Woolfson Eye Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Minnesota Eye Consultants
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
Pamel Vision & Laser Group
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mt. Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
OSU Department of Ophthalmoloty
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Revision Advanced Laser Eye Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43240
Country
United States
Facility Name
Dell Laser Consultants
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Slade & Baker Vision Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States

12. IPD Sharing Statement

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

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