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

• Status: Terminated
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Topcon Medical Systems, Inc.
• Treatments: Riboflavin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria

• 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