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

Ectasia Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01398839
• Other study ID #: CXL-002
• 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 test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL) when used to treat ectasia.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 103
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ectasia

Intervention

Device:
• VEGA UV-A Illumination System
Only subjects assigned to the treatment group will receive treatment with the UV Light

Drug:
• Riboflavin
Both treatment and sham groups will receive riboflavin

Locations

Country	Name	City	State
United States	Woolfson Eye Institute	Atlanta	Georgia
United States	Dell Laser Consultants	Austin	Texas
United States	Minnesota Eye Consultants, P.A.	Bloomington	Minnesota
United States	Cleveland Clinic-Cole Eye Institute	Cleveland	Ohio
United States	ReVision Advanced Laser Eye Center	Columbus	Ohio
United States	The Ohio State University College of Medicine	Columbus	Ohio
United States	Slade & Baker Vision	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		6 Months