Clinical trial NCT06859411: Prognosis of Posterior Lamellar Keratoplasty, an Observational Cohort Study
Official title: Prognosis of Posterior Lamellar Keratoplasty: an Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fuchs' Endothelial Corneal Dystrophy
Pseudophakic Bullous Keratopathy
Keywords: posterior lamellar keratoplasty
cornea
DMEK
DSAEK
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who received a posterior lamellar keratoplasty

Brief 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 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 outcomes:
measure: BSCVA
timeFrame: 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 outcomes:
measure: ECD
timeFrame: at 1 month, 3 months, 6 months and every year up to 10 years after surgery
measure: CCT
timeFrame: at 1 month, 3 months, 6 months and every year up to 10 years after surgery
measure: post-operative complication
timeFrame: up to 10 years after surgery
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville Hopital de Mercy
Study officials:
affiliation: CHR Metz Thionville Hopital de Mercy
name: Jean-Marc PERONE, MD
role: PRINCIPAL_INVESTIGATOR
References: