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

• Status: Terminated
• Trial end date: 2011-12-01
• 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 keratoconus.

• 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

• 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

Exclusion Criteria:

• 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.