An observational study in Fuchs' Endothelial Corneal Dystrophy and Pseudophakic Bullous Keratopathy, sponsored by Centre Hospitalier Régional Metz-Thionville. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Centre Hospitalier Régional Metz-Thionville · Observational
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.
92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 144 across 26 observational studies indexed under Fuchs' Endothelial Dystrophy.
Browse Fuchs' Endothelial Dystrophy studies →Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 123 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients who received a posterior lamellar keratoplasty
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who received Descemet Membrane Endothelial Keratoplasty
Procedure: visual acuity comparaison
Patients who received Descemet Stripping Automated Endothelial Keratoplasty with preoperative graft thicker than 160 µm
Procedure: visual acuity comparaison
DSAEK: patients who received Descemet Stripping Automated Endothelial Keratoplasty with preoperative graft thinner than 160 µm
Procedure: visual acuity comparaison
Data collection
BSCVA
best spectacle-corrected visual acuity (logMAR)
Time frame: 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
ECD
endothelial cell count (cells/mm²)
Time frame: at 1 month, 3 months, 6 months and every year up to 10 years after surgery
CCT
central cornea thickness (µm)
Time frame: 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)
Time frame: up to 10 years after surgery
Plan to share: No — No According to French law and the French Data Protection Authority (CNIL), the investigators will not be able to publicly share individual participant data; however, the investigators plan to share the conclusions through peer-reviewed publications and conferences.
Started Jun 2024 (actual). Primary completion is estimated for Jan 2040, 187 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fuchs' Endothelial Dystrophy →
Centre Hospitalier Régional Metz-Thionville →