Prognosis of Posterior Lamellar Keratoplasty, an Observational Cohort Study (CORNEACOHORT)

Prognosis of Posterior Lamellar Keratoplasty: an Observational Cohort Study

Over the past decade, the management of Fuchs' endothelial corneal dystrophy (FECD) and pseudophakic bullous keratopathy (PBK) has been revolutionized by the development of posterior lamellar keratoplasty techniques: DSAEK and DMEK.

DSAEK (Descemet Stripping Automated Endothelial Keratoplasty) involves replacing the patient's endothelium and pathological descemetum with a descemetic endothelial graft combined with a thin stromal lamella. The endothelial density of the grafts is generally greater than 2,400 cells/mm². Depending on the grafting center and tissue bank, grafts may be either pre-cut in the tissue bank or cut on the operating table by the surgeon himself.

The donor graft is placed on an artificial anterior chamber, and automated microkeratome cutting produces grafts with an average thickness of 100 to 200µm, sometimes less than 100um (known as UT-DSAEK or ultra-thin DSAEK).

DMEK (Descemet Membrane Endothelial Keratoplasty) is a strictly endothelium and Descemet's membrane graft, as close as possible to the original anatomy of the cornea. The graft is dissected manually either in a tissue bank (pre-cut grafts) or on the operating table by the surgeon. The thickness of the graft is between 15 and 18 microns.

The primary objective of this observational cohort is to compare the evolution of visual acuity after DMEK, DSAEK or UT-DSAEK transplantation.

Secondary objectives are to compare the evolution of endothelial cell density, corneal thickness and early and late post-operative complications, and to identify factors predictive of these different endpoints.

Study Overview

• Status: Recruiting
• Conditions: Pseudophakic Bullous Keratopathy; Fuchs' Endothelial Corneal Dystrophy
• Intervention / Treatment: Procedure: visual acuity comparaison

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Arpiné EL NAR, PhD; Phone Number: 0033387557766; Email: projet-recherche-clinique@chr-metz-thionville.fr

Study Locations

• France
  • Metz, France, 57085
    • Recruiting
    • CHR Metz-Thionville Hopital de Mercy
    • Principal Investigator: Jean-Marc PERONE, MD
    • Contact: Arpiné EL NAR, PhD; Phone Number: 0033387557766; Email: projet-recherche-clinique@chr-metz-thionville.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

patients who received a posterior lamellar keratoplasty

Description

Inclusion Criteria:

• patients who received a posterior lamellar keratoplasty in Metz-Thionville Regional Hospital between 2012 and 2030

Exclusion Criteria:

• patients refusing to take part in the study

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DMEK; Patients who received Descemet Membrane Endothelial Keratoplasty	Procedure: visual acuity comparaison; Data collection
DSAEK; Patients who received Descemet Stripping Automated Endothelial Keratoplasty with preoperative graft thicker than 160 µm	Procedure: visual acuity comparaison; Data collection
UT-DSAEK; DSAEK: patients who received Descemet Stripping Automated Endothelial Keratoplasty with preoperative graft thinner than 160 µm	Procedure: visual acuity comparaison; Data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BSCVA	best spectacle-corrected visual acuity (logMAR)	at 1 year after surgery, but also at day 8, day 15, 1 month, 3 months, 6 months and every year up to 10 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECD	endothelial cell count (cells/mm²)	at 1 month, 3 months, 6 months and every year up to 10 years after surgery
CCT	central cornea thickness (µm)	at 1 month, 3 months, 6 months and every year up to 10 years after surgery
post-operative complication	graft reject (yes/no), graft detachment (yes/no), graft failure (yes/no), eye infection (yes/no)	up to 10 years after surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Jean-Marc PERONE, MD, CHR Metz Thionville Hopital de Mercy

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): January 1, 2040
• Study Completion (Estimated): January 1, 2040

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: cornea; DMEK; DSAEK; posterior lamellar keratoplasty
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Eye Diseases; Corneal Diseases; Eye Diseases, Hereditary; Fuchs' Endothelial Dystrophy; Corneal Dystrophies, Hereditary
• Other Study ID Numbers: 2024-11Obs-CHRMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

No

According to the French law and the French Data Protection Authority (CNIL), we won't be able to publicly share individual participant data, but we plan to share their conclusions through peer-reviewed publications and conferences.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No