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

Keratoconus and Ectasia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01398852
• Other study ID #: CXL-003
• Status: Terminated
• Phase: Phase 3
• Start date: December 2010
• Est. completion date: July 2012

Study information

• Verified date: June 2022
• Source: Topcon Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 500
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus
• Keratoconus and Ectasia

Intervention

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

Locations

Country	Name	City	State
United States	Woolfson Eye Institute	Atlanta	Georgia
United States	Dell Laser Consultants	Austin	Texas
United States	Minnesota Eye Consultants	Bloomington	Minnesota
United States	Massachusetts Eye And Ear Infirmary	Boston	Massachusetts
United States	Cleveland Clinic-Cole Eye Institute	Cleveland	Ohio
United States	OSU Department of Ophthalomogy	Columbus	Ohio
United States	ReVision Advanced Laser Eye Center	Columbus	Ohio
United States	Slade and Baker Vision Center	Houston	Texas
United States	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	New York	New York
United States	Barnet Dulaney Perkins Eye Center	Phoenix	Arizona
United States	The Eye Institute of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Topcon Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Corneal Curvature		24 MO