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

Phase 3

Terminated

• Conditions: Ectasia
• Interventions: Device: VEGA UV-A Illumination System; Drug: Riboflavin

• Registration Number: NCT01398839
• Lead Sponsor: Topcon Medical Systems, Inc.

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 ectasia.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-07-10
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-21
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2012-12-13
• Results First Submitted QC: 2013-01-25
• Results First Posted: 2013-03-04
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CXL Treatment	VEGA UV-A Illumination System	-
Sham Control	Riboflavin	-
CXL Treatment	Riboflavin	-

Primary Outcome Measures

Name	Time	Method
Changes in Corneal Curvature	6 Months

Trial Locations

Locations (12)

Barnet Dulaney Perkins Eye Center; 🇺🇸 Phoenix, Arizona, United States

Slade & Baker Vision; 🇺🇸 Houston, Texas, United States

The Eye Institute of Utah; 🇺🇸 Salt Lake City, Utah, United States

Woolfson Eye Institute; 🇺🇸 Atlanta, Georgia, United States

Cleveland Clinic-Cole Eye Institute; 🇺🇸 Cleveland, Ohio, United States

ReVision Advanced Laser Eye Center; 🇺🇸 Columbus, Ohio, United States

Minnesota Eye Consultants, P.A.; 🇺🇸 Bloomington, Minnesota, United States

Laser and Corneal Surgery Assoc. PC; 🇺🇸 New York, New York, United States

Mt. Sinai Hospital; 🇺🇸 New York, New York, United States

The Ohio State University College of Medicine; 🇺🇸 Columbus, Ohio, United States

Pamel Vision & Laser Group; 🇺🇸 New York, New York, United States

Dell Laser Consultants; 🇺🇸 Austin, Texas, United States