Prognosis of Posterior Lamellar Keratoplasty, an Observational Cohort Study

Last updated: February 28, 2025
Sponsor: Centre Hospitalier Régional Metz-Thionville
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

visual acuity comparaison

Clinical Study ID

NCT06859411
2024-11Obs-CHRMT
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • patients refusing to take part in the study

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: visual acuity comparaison
Phase:
Study Start date:
June 01, 2024
Estimated Completion Date:
January 01, 2040

Connect with a study center

  • CHR Metz-Thionville Hopital de Mercy

    Metz, 57085
    France

    Active - Recruiting

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