NCT06859411

Prognosis of Posterior Lamellar Keratoplasty, an Observational Cohort Study

Prognosis of Posterior Lamellar Keratoplasty: an Observational Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Centre Hospitalier Régional Metz-Thionville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Fuchs' Endothelial Corneal Dystrophy
• Pseudophakic Bullous Keratopathy

Interventions

Type	Name	Description
PROCEDURE	visual acuity comparaison	Data collection

Timeline

• Start date: 2024-06-01
• Primary completion: 2040-01-01
• Completion: 2040-01-01
• First posted: 2025-03-05
• Last updated: 2025-03-05

Locations

1 site across 1 country: France