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

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01190306
• Other study ID #: CXL-001
• Status: Terminated
• Phase: Phase 3
• Start date: August 2010
• Est. completion date: December 2011

Study information

• Verified date: July 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 test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL), when used to treat keratoconus.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 127
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Keratoconus

Intervention

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

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	OSU Department of Ophthalmoloty	Columbus	Ohio
United States	Revision Advanced Laser Eye Center	Columbus	Ohio
United States	Slade & Baker Vision Center	Houston	Texas
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

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	Change in Corneal Curvature.		6 Months