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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Ectasia

In brief

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.

Key facts

Study ID

NCT01398839

Run by

Topcon Medical Systems, Inc.

People needed

103

Starts

2010-12-01

Expected to finish

2012-07-01

Last updated by the study team

2022-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Barnet Dulaney Perkins Eye Center — Phoenix, Arizona, United States
• Woolfson Eye Institute — Atlanta, Georgia, 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
• Pamel Vision & Laser Group — New York, New York, United States
• Cleveland Clinic-Cole Eye Institute — Cleveland, Ohio, United States
• The Ohio State University College of Medicine — Columbus, Ohio, United States
• ReVision Advanced Laser Eye Center — Columbus, Ohio, United States
• Dell Laser Consultants — Austin, Texas, United States
• Slade & Baker Vision — Houston, Texas, United States
• The Eye Institute of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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