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NCT Number: NCT06859411

Prognosis of Posterior Lamellar Keratoplasty

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Metz-Thionville Hopital de Mercy

Metz, 57085, France

Location status: Recruiting

Location contact

Arpiné EL NAR, PhD

CONTACT

[email protected]

0033387557766

Jean-Marc PERONE, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

visual acuity comparaison

Procedure

Data collection

Primary outcomes

  1. 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

    best spectacle-corrected visual acuity (logMAR)

Secondary outcomes

  1. ECD

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

    endothelial cell count (cells/mm²)

  2. CCT

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

    central cornea thickness (µm)

  3. post-operative complication

    Time frame: up to 10 years after surgery

    graft reject (yes/no), graft detachment (yes/no), graft failure (yes/no), eye infection (yes/no)

Study contacts

Contact information is provided by the study sponsor or research team.

Arpiné EL NAR, PhD

CONTACT

[email protected]

0033387557766

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

Prognosis of Posterior Lamellar Keratoplasty: an Observational Cohort Study

Acronym: CORNEACOHORT

Important dates

Study start
2024
Primary completion
2040
Study completion
2040
First posted
Mar 5, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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