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

NCT02068430 | Completed Phase 1

• 1 other identifier: AAAD2184
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Ulcers

Keywords

Corneal Ulcers; cross-linking; UVA; Riboflavin

Outcome Measures

Primary Outcomes (2)

• Number of patients with healed corneal ulcers

  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.

  6 months

• Number of adverse events

  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.

  6 months

Study Arms (1)

Riboflavin 0.1% & UV-X™ Illumination System

EXPERIMENTAL

UV-X Cross linking: After topical anesthesia, 1 drop of Riboflavin 0.1% ophthalmic solution will be instilled topically in the eye every 2 minutes for 30 minutes. At the end of the 30 minute riboflavin pre-treatment period, the eye will be examined with blue light for the presence of a yellow flare in the anterior chamber. When the yellow flare in the anterior chamber is confirmed, the eye will be aligned under the UV-X™ light with the treatment plane at a working distance that is 50mm from the UV-X™ beam aperture.

Drug: Riboflavin 0.1%; Other: UV-X™ Illumination System

Interventions

Riboflavin 0.1% DRUG

After topical anesthesia, 1 drop of Riboflavin 0.1% ophthalmic solution will be instilled topically in the eye every 2 minutes for 30 minutes. At the end of the 30 minute riboflavin pre-treatment period, the eye will be examined with blue light for the presence of a yellow flare in the anterior chamber.

Also known as: Riboflavin

Riboflavin 0.1% & UV-X™ Illumination System

UV-X™ Illumination System OTHER

When the yellow flare in the anterior chamber is confirmed, the eye will be aligned under the UV-X™ light with the treatment plane at a working distance that is 50mm from the UV-X™ beam aperture. The correct aperture setting will be selected for the size of the eye (7.5 , 9.5, or 11 mm), and the eye will be irradiated for 30 minutes, during which time instillation of riboflavin will continue (1 drop every 2 minutes). At the end of 30 minutes, the UV light source will automatically switch to the off position. The operator will keep track of irradiation time independently to confirm the actual treatment time.

Also known as: UVA light

Riboflavin 0.1% & UV-X™ Illumination System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stephen Trokel: lead

Study Sites (1)

Harkness Eye Institute Columbia University

New York, New York, 10035, United States

Location

MeSH Terms

Conditions

Corneal Ulcer

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Keratitis; Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Study Officials

• Stephen Trokel, MD

  Columbia University Dept. of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical Ophthalmology

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: February 21, 2014
• Study Start: November 1, 2008
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

US (1)