Safety and Effectiveness Study of the VEGA UV-A System for Cross-linking in Eyes With Keratoconus and Ectasia

Stopped early · Phase 3

Conditions studied: Keratoconus and Ectasia

In brief

The purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.

Key facts

Study ID

NCT01398852

Run by

Topcon Medical Systems, Inc.

People needed

500

Starts

2010-12-01

Expected to finish

2012-07-01

Last updated by the study team

2022-06-29

Who can join

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

You may qualify if…

• 12 years of age or older
• Diagnosis of Keratoconus or Ectasia
• Central or Inferior steepening on the Pentacam map
• Topography consistent with Keratoconus or Ectasia
• BSCVA 20/20 or worse
• Removal of contact lenses for 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
• Corneal pachymentry equal to or greater and 400
• Previous ocular condition in the eyes to be treated that may predispose the eye for future complications
• A history of chemical injury or delayed healing
• Pregnancy
• A known sensitivity to the study medications
• Nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests
• Presence or history of any other condition or finding that makes the patient unsuitable as a candidate

Where it is running

• Barnet Dulaney Perkins Eye Center — Phoenix, Arizona, United States
• Woolfson Eye Institute — Atlanta, Georgia, United States
• Massachusetts Eye And Ear Infirmary — Boston, Massachusetts, United States
• Minnesota Eye Consultants — 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
• ReVision Advanced Laser Eye Center — Columbus, Ohio, United States
• OSU Department of Ophthalomogy — Columbus, Ohio, United States
• Dell Laser Consultants — Austin, Texas, United States
• Slade and Baker Vision Center — Houston, Texas, United States
• The Eye Institute of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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