Prognosis of Posterior Lamellar Keratoplasty, an Observational Cohort Study

NCT06859411 | Recruiting

• 1 other identifier: 2024-11Obs-CHRMT
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Fuchs' Endothelial Corneal Dystrophy; Pseudophakic Bullous Keratopathy

Keywords

posterior lamellar keratoplasty; cornea; DMEK; DSAEK

Outcome Measures

Primary Outcomes (1)

• BSCVA

  best spectacle-corrected visual acuity (logMAR)

  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 Outcomes (3)

• ECD

  at 1 month, 3 months, 6 months and every year up to 10 years after surgery

• CCT

  at 1 month, 3 months, 6 months and every year up to 10 years after surgery

• post-operative complication

  up to 10 years after surgery

Study Arms (3)

DMEK

Patients who received Descemet Membrane Endothelial Keratoplasty

Procedure: visual acuity comparaison

DSAEK

Patients who received Descemet Stripping Automated Endothelial Keratoplasty with preoperative graft thicker than 160 µm

Procedure: visual acuity comparaison

UT-DSAEK

DSAEK: patients who received Descemet Stripping Automated Endothelial Keratoplasty with preoperative graft thinner than 160 µm

Procedure: visual acuity comparaison

Interventions

visual acuity comparaison PROCEDURE

Data collection

DMEK; DSAEK; UT-DSAEK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who received a posterior lamellar keratoplasty

You may qualify if:

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

You may not qualify if:

• patients refusing to take part in the study

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville Hopital de Mercy

Metz, 57085, France

RECRUITING

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy; Corneal Diseases

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jean-Marc PERONE, MD

  CHR Metz Thionville Hopital de Mercy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arpiné EL NAR, PhD

CONTACT

0033387557766; projet-recherche-clinique@chr-metz-thionville.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: June 1, 2024
• Primary Completion (Estimated): January 1, 2040
• Study Completion (Estimated): January 1, 2040
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)