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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

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