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Prognosis of Posterior Lamellar Keratoplasty

Prognosis of Posterior Lamellar Keratoplasty: an Observational Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06859411
Acronym
CORNEACOHORT
Enrollment
1000
Registered
2025-03-05
Start date
2024-06-01
Completion date
2040-01-01
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fuchs' Endothelial Corneal Dystrophy, Pseudophakic Bullous Keratopathy

Keywords

posterior lamellar keratoplasty, cornea, DMEK, DSAEK

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.

Interventions

PROCEDUREvisual acuity comparaison

Data collection

Sponsors

Centre Hospitalier Régional Metz-Thionville
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
BSCVAat 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 surgerybest spectacle-corrected visual acuity (logMAR)

Secondary

MeasureTime frameDescription
ECDat 1 month, 3 months, 6 months and every year up to 10 years after surgeryendothelial cell count (cells/mm²)
CCTat 1 month, 3 months, 6 months and every year up to 10 years after surgerycentral cornea thickness (µm)
post-operative complicationup to 10 years after surgerygraft reject (yes/no), graft detachment (yes/no), graft failure (yes/no), eye infection (yes/no)

Countries

France

Contacts

CONTACTArpiné EL NAR, PhD
projet-recherche-clinique@chr-metz-thionville.fr0033387557766
PRINCIPAL_INVESTIGATORJean-Marc PERONE, MD

CHR Metz Thionville Hopital de Mercy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026