Improving corneal graft resistance in artificial corneas
Official title: Corneal Collagen Crosslinking to Increase the Resistance of the Graft Used as a Support for the Boston Keratoprosthesis Type I Against Corneal Melting
Run by Centre hospitalier de l'Université de Montréal (CHUM) · NCT03041883 · Data updated 2026-11-12
This study is testing a new method using riboflavin and UV light to see if it can make artificial corneas last longer and prevent them from melting for people who can't have regular corneal transplants.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Status | Recruiting |
| Started | January 4, 2017 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | April 28, 2026 |
| Trial ID | NCT03041883 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals who are suitable for KPro type I implantation and can provide informed consent.
✕Probably not a fit
Patients with severe ocular surface dryness or other contraindications to KPro type I will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the safety and effectiveness of corneal collagen crosslinking using riboflavin and ultraviolet A to enhance the resistance of the graft supporting the Boston keratoprosthesis (KPro) type I against corneal melting. The KPro is an artificial cornea designed for patients with a low success rate for traditional corneal transplants. The study will involve de-epithelization of the corneal graft support followed by riboflavin instillation. The goal is to reduce the risk of corneal melting, which can lead to the extrusion of the KPro.
Why it matters
Potential benefit: If successful, this approach could significantly improve the longevity and effectiveness of artificial corneas for patients with severe corneal conditions.
How similar studies have gone: While corneal collagen crosslinking has been used in other contexts, this specific application for KPro type I is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Candidate for KPro type I * Capacity to give written consent * Ability to be followed for the duration of the study Exclusion Criteria: * Participation in another interventional study * Failure to wear a therapeutic contact lens due to abnormalities of the eyelids. * Inability to give written consent Contraindications to the KPro type I: * Severe dryness with keratinization of the ocular surface * Intraocular tumor * Terminal glaucoma * Inoperable retinal detachment * Phthisis bulbi
Where it's running
-
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Marie-Claude Robert, MD — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Marie-Catherine Tessier
- Email: marie-catherine.tessier.chum@ssss.gouv.qc.ca
- Phone: 514-890-8000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.