Prognosis of Posterior Lamellar Keratoplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: visual acuity comparaison.
- Who it may be relevant to
- Registry conditions: Fuchs' Endothelial Corneal Dystrophy, Pseudophakic Bullous Keratopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prognosis of Posterior Lamellar Keratoplasty: an Observational Cohort Study
Overview
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
- Procedure visual acuity comparaison
Data collection
Primary outcome measures
- BSCVA [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]
Secondary outcome measures (3)
- ECD [Time frame: at 1 month, 3 months, 6 months and every year up to 10 years after surgery]
- CCT [Time frame: at 1 month, 3 months, 6 months and every year up to 10 years after surgery]
- post-operative complication [Time frame: up to 10 years after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHR Metz-Thionville Hopital de Mercy — Metz
Publications
- Delean S, Goetz C, Zevering Y, Perone JM. Central Corneal Thickness 6 Postoperative Months After Pseudophakic-Descemet Membrane Endothelial Keratoplasty, Triple-Descemet Membrane Endothelial Keratoplasty, and Cataract Surgery Alone: A Retrospective Cohort Study and Literature Review. Cornea. 2026 Mar 11. doi: 10.1097/ICO.0000000000004144. Online ahead of print. PMID 41921039
Identifiers
NCT: NCT06859411 · 2024-11Obs-CHRMT