Prognosis of Posterior Lamellar Keratoplasty: an Observational Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
View:

• patients who received a posterior lamellar keratoplasty in Metz-Thionville Regional Hospital between 2012 and 2030

Locations
Other Locations
France
CHR Metz-Thionville Hopital de Mercy
RECRUITING
Metz
Contact Information
Primary
Arpiné EL NAR, PhD
projet-recherche-clinique@chr-metz-thionville.fr
0033387557766
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2040-01-01
Participants
Target number of participants: 1000
Treatments
DMEK
Patients who received Descemet Membrane Endothelial Keratoplasty
DSAEK
Patients who received Descemet Stripping Automated Endothelial Keratoplasty with preoperative graft thicker than 160 µm
UT-DSAEK
DSAEK: patients who received Descemet Stripping Automated Endothelial Keratoplasty with preoperative graft thinner than 160 µm
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Régional Metz-Thionville

This content was sourced from clinicaltrials.gov

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