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Open-label Prospective Clinical Trial Evaluating the Safety and Efficacy of Biosynthetic CLP-PEG-MPC Corneal Implants in Patients Undergoing High-risk Deep Anterior Lamellar Keratoplasty.

NCT05667337 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-12-28

No results posted yet for this study

Summary

This is an open-label and prospective clinical trial, in which a maximum of 5 eyes of 5 patients will receive a CLP-PEG-MPC synthetic cornea during deep anterior lamellar keratoplasty (DALK) surgery and will be followed up over 24 months.

Conditions

  • High-risk Corneal Transplantation
  • Corneal Blindess
  • Corneal Inflammation
  • Deep Anterior Lamellar Keratoplasty

Interventions

DEVICE

CLP-PEG-MPC

Implantation of a 500 um thick biosynthetic corneal implant utilizing DALK surgical technique

PROCEDURE

Human donor cornea penetrating keratoplasty

Implantation of a human donor cornea graft utilizing PKP surgical technique

Sponsors & Collaborators

  • Maisonneuve-Rosemont Hospital

    collaborator OTHER

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

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2040-01-01
Completion
2040-06-01

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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 NCT05667337 on ClinicalTrials.gov