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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Keratoconus

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 keratoconus.

Key facts

Study ID

NCT01190306

Run by

Topcon Medical Systems, Inc.

People needed

127

Starts

2010-08-01

Expected to finish

2011-12-01

Last updated by the study team

2022-07-12

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Barnet Dulaney Perkins Eye Center — Phoenix, Arizona, United States
• Woolfson Eye Institute — Atlanta, Georgia, United States
• Minnesota Eye Consultants — Bloomington, Minnesota, United States
• Pamel Vision & Laser Group — New York, New York, United States
• Mt. Sinai Hospital — New York, New York, United States
• OSU Department of Ophthalmoloty — Columbus, Ohio, United States
• Revision Advanced Laser Eye Center — Columbus, Ohio, United States
• Dell Laser Consultants — Austin, Texas, United States
• Slade & Baker Vision Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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