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Clinical Trials in France / NCT06859411
Recruiting Observational

Prognosis of Posterior Lamellar Keratoplasty

NCT06859411 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-06-01
Last updated
2026-06-24

Condition(s) studied

Fuchs' Endothelial Corneal DystrophyPseudophakic Bullous Keratopathy

Investigational drug(s) / intervention(s)

visual acuity comparaison

visual acuity comparaison: Data collection

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHR Metz-Thionville Hopital de Mercy Metz France Recruiting

More Centre Hospitalier Régional Metz-Thionville trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06859411 on ClinicalTrials.gov ↗ ← All trials in France