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Frozen Versus Fresh Corneal Carriers for the Boston KPro Type I Donor Carriers

NCT01950598 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2021-01-28

No results posted yet for this study

Summary

The purpose of this study is to determine whether frozen corneas are as safe and effective as fresh corneas for use as carriers with the Boston Keratoprosthesis type I (KPro) over long term follow-up.

Corneal transplantation is typically performed using fresh, transparent corneas. With KPro surgery, the corneal transplant only serves as a carrier to suture the KPro in place. The cornea used in KPro surgery does not need to be clear like a normal transplant. Frozen corneal tissue can be used to repair the cornea in cases of emergency but the tissue is not transparent and does not allow good vision. We hypothesize that frozen grafts are equivalent as fresh grafts when used as carrier for the KPro.

Conditions

  • Corneal Blindness
  • Boston Keratoprosthesis Type I Candidate

Interventions

PROCEDURE

Boston KPro type I - fresh graft

Boston KPro mounted on fresh corneal carrier graft for implantation

PROCEDURE

Boston KPro type I surgery - frozen graft

Boston KPro mounted on frozen corneal carrier graft for implantation

Sponsors & Collaborators

  • Fonds de recherche en ophtalmologie de l'Université de Montréal

    collaborator OTHER

  • Marie-Claude Robert

    lead OTHER

Principal Investigators

  • Mona Harissi-Dagher, M.D. · CHUM - Hôpital Notre-Dame

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2020-11-30
Completion
2020-11-30

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 NCT01950598 on ClinicalTrials.gov