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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

This study is designed to evaluate the safety and effectiveness of using the UV-X™ system for treating corneal ulcers that have proven refractory to conventional antibiotic treatment.

The UV-X™ system is a combination product consisting of a UVA 365 nm wavelength light source (UV-X™ Illumination System) and riboflavin (Medio-Cross® Riboflavin 0.1%) ophthalmic solution. The therapeutic effect is mediated by the photochemical interaction of the ultraviolet (UV) light with the riboflavin that has been saturated into the infected corneal stromal tissues.

The photochemical interaction of UVA light with riboflavin has been used to sterilize pathogens in blood and blood products. Pathogens including viruses, bacteria, fungi, and protozoa have shown to be sterilized using this photochemical process. Presumably singlet oxygen is produced by the interaction of the UVA with the riboflavin. It is this singlet oxygen that interacts with the pathogen's Deoxyribonucleic acid (DNA) in a sufficiently disruptive manner to render the exposed field sterile.

The cross-linking improves mechanical properties in the anterior stroma and has been shown to stabilize corneal structure in patients with progressive keratoconus and ectasias following refractive surgery. The same technology has been applied to a handful of patients with corneal ulcers and a single small series with bullous keratopathy. In no case was the patient worsened by this treatment. In the majority of the cases, considerable clinical reversal of a deteriorating clinical course was obtained. There has been debate about the mechanism of action of this beneficial effect. It has been speculated that a proteolytic collagenase enzyme was destroyed by the photochemical process. As an alternate, it has been suggested
Sponsor: Stephen Trokel

Current Primary Outcome:

• Number of patients with healed corneal ulcers [ Time Frame: 6 months ]
  Stabilization of the corneal ulcer: The endpoint will be the healing of the ulcer with re-epithelialization of its surface and stromal clearing. The patients will be followed on a daily basis until the ulcer has shown definite signs of resolution requiring a longer interval between exams or alternative therapeutic measures become necessary.
• Number of adverse events [ Time Frame: 6 months ]
  The conditions to be treated are severe and have considerable functional loss. Vision loss, pain, corneal perforation, and blindness are often outcomes of severe progressive corneal ulcers. An abrupt worsening of the clinical appearance of the cornea or a worsening of symptoms will be considered as an adverse event.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Columbia University

Dates:
Date Received: November 20, 2012
Date Started: November 2008
Date Completion:
Last Updated: July 28, 2016
Last Verified: July 2016