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

Primary Purpose

Keratoconus and Ectasia

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

About this trial

This is an interventional other trial for Keratoconus and Ectasia

Eligibility Criteria

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

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

Sites / Locations

  • Barnet Dulaney Perkins Eye Center
  • Woolfson Eye Institute
  • Massachusetts Eye And Ear Infirmary
  • Minnesota Eye Consultants
  • Laser and Corneal Surgery Assoc. PC
  • Mt Sinai Hospital
  • Pamel Vision & Laser Group
  • Cleveland Clinic-Cole Eye Institute
  • ReVision Advanced Laser Eye Center
  • OSU Department of Ophthalomogy
  • Dell Laser Consultants
  • Slade and Baker Vision Center
  • The Eye Institute of Utah

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CXL Treatment

Arm Description

All eyes to be treated with riboflavin and UV light

Outcomes

Primary Outcome Measures

Changes in Corneal Curvature

Secondary Outcome Measures

Full Information

First Posted
July 11, 2011
Last Updated
June 6, 2022
Sponsor
Topcon Medical Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01398852
Brief Title
Safety and Effectiveness Study of the VEGA UV-A System for Cross-linking in Eyes With Keratoconus and Ectasia
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 Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (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 evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CXL Treatment
Arm Type
Experimental
Arm Description
All eyes to be treated with riboflavin and UV light
Intervention Type
Drug
Intervention Name(s)
Riboflavin
Intervention Description
Riboflavin is a solution that will be delivered to the treatment area
Intervention Type
Device
Intervention Name(s)
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
Primary Outcome Measure Information:
Title
Changes in Corneal Curvature
Time Frame
24 MO

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

12. IPD Sharing Statement

Learn more about this trial

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

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