Corneal Collagen Crosslinking to Increase the Resistance of the Graft Used as a Support for the Boston Keratoprosthesis Type I Against Corneal Melting
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to demonstrate the safety and efficacy of the corneal collagen crosslinking with riboflavin and ultraviolet A in aim to increase the resistance of the graft used as a support for the Boston keratoprosthesis (KPro) type I against corneal melting (keratolysis or sterile necrosis).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Candidate for KPro type I
• Capacity to give written consent
• Ability to be followed for the duration of the study
Locations
Other Locations
Canada
Centre Hospitalier de l'Université de Montréal
RECRUITING
Montreal
Contact Information
Primary
Marie-Catherine Tessier
marie-catherine.tessier.chum@ssss.gouv.qc.ca
514-890-8000
Backup
Soumaya Bouhout
soumiya.bouhout@gmail.com
514-264-0436
Time Frame
Start Date: 2017-01-04
Estimated Completion Date: 2025-01
Participants
Target number of participants: 40
Treatments
Experimental: Kpro with crosslinked graft-support
Patient will receive a crosslinked corneal graft-support for the KPro type I. Under sterile conditions, the corneo-scleral button will be inspected, then placed on an artificial anterior chamber. The epithelium of the donor will be removed mechanically. Then one drop of riboflavin 0.1%/dextran 20% will be applied to 3 minutes on the de-epithelialized cornea for 15 minutes. Then, the source of ultraviolet A (UVA) will be irradiating the cornea for 30 minutes with a wavelength of 370 nanometer(nm) length with 5.4 joules(J)/ square centimeter (cm2) and 3 milliwatts(mW)/cm2. Meanwhile, the instillation of a drop of 0.1% riboflavin/dextran 20% continues every 5 minutes. Goggles against UVA are mandatory. The crosslinked graft-support will be forwarded to the surgeon according to standard procedure.
Active_comparator: KPro with normal graft-support
Patient wil receive a normal graft-support for the KPro type I. Under sterile conditions, the corneo-scleral button will be inspected, then placed on an artificial anterior chamber. The epithelium of the donor will be removed mechanically. Then, one drop of riboflavin 0.1% / dextran 20% will be applied to 30 secondes for 5 minutes on the de-epithelialized cornea.The minimally manipulated normal graft-support will be forwarded to the surgeon according to standard procedure.
Authors
Mona Harissi-Dagher
Related Therapeutic Areas
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators: Maisonneuve-Rosemont Hospital