NCT03041883 Corneal Collagen Crosslinking to Increase the Resistance of the Support Graft of the KPro Type I Against Corneal Melting
| NCT ID | NCT03041883 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Corneal Melting in Boston Keratoprosthesis Type I |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2017-01-04 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2017-01-04 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Marie-Claude Robert, MD
PRINCIPAL INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)
Frequently Asked Questions
Who can join the NCT03041883 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Corneal Melting in Boston Keratoprosthesis Type I. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03041883 currently recruiting?
Yes, NCT03041883 is actively recruiting participants. Contact the research team at marie-catherine.tessier.chum@ssss.gouv.qc.ca for enrollment information.
Where is the NCT03041883 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT03041883 clinical trial?
NCT03041883 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The principal investigator is Marie-Claude Robert, MD at Centre hospitalier de l'Université de Montréal (CHUM). The trial plans to enroll 40 participants.