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Corneal Collagen Crosslinking to Increase the Resistance of the Support Graft of the KPro Type I Against Corneal Melting

NCT03041883 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-28

No results posted yet for this study

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).

Conditions

  • Corneal Melting in Boston Keratoprosthesis Type I

Interventions

PROCEDURE

Crosslinking with riboflavin of the corneal graft-support

Corneal graft support for the KPro will be crosslinked and used with the standard surgical technique

PROCEDURE

De-epithelisation of the corneal graft support with instillation of riboflavin

Corneal graft-support will be de-epithelialized and soaked with riboflavin and then used with the standard surgical technique

Sponsors & Collaborators

  • Maisonneuve-Rosemont Hospital

    collaborator OTHER

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Marie-Claude Robert, MD · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-04
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03041883 on ClinicalTrials.gov