Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Refractory Corneal Infection

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes with Corneal Infection. The treatment of UV-X system is to use the eyedrops of the riboflavin, also known as vitamin B2, and ultraviolet A (UVA) light. The eye drops are placed in affected eye and then affected cornea is exposed to UVA.

UVA/riboflavin corneal collagen cross-linking was first used to treat patients in 1998 in Dresden, Germany. Data to date obtained mostly by physicians outside the United States has strongly suggested this treatment as an acceptable alternative, and many subjects have had a lasting effect (no progression) 3-5 years after their initial treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Stephen Trokel
• Treatments: Ophthalmic Solutions; Riboflavin

Criteria

Inclusion Criteria:

• Subjects who have one eye that meets the following criteria:

• 18 years of age or older

• Having a diagnosis of a corneal ulcer.

• Corneal scraping sent for cultures and sensitivities.

• Having been treated for at least three days with conventional broad spectrum anti infective therapy without improvement

• Showing no response to the therapy by one or more of the following criteria:

• Progressive thinning of cornea

• Increasing diameter of corneal ulcer

• Increasing diameter of corneal infiltrate

• Persistent epithelial defect

• Persistent inflammatory signs as iritis and hypopyon

• Persistent pain

Exclusion Criteria:

• All subjects meeting any of the following criteria will be excluded from this study:

• A corneal ulcer that has perforated

• A corneal ulcer that has produced a descemetocele.

• Women who may be breast-feeding and pregnant women.

• Herpetic infection suggested by history or clinical evaluation.