CHR Metz-Thionville Hopital de Mercy
Metz, 57085, France
Location status: Recruiting
Location contact
Arpiné EL NAR, PhD
CONTACT
Jean-Marc PERONE, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06859411
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Metz, 57085, France
Location status: Recruiting
Arpiné EL NAR, PhD
CONTACT
Jean-Marc PERONE, MD
PRINCIPAL_INVESTIGATOR
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Data collection
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)
Time frame: at 1 month, 3 months, 6 months and every year up to 10 years after surgery
endothelial cell count (cells/mm²)
Time frame: at 1 month, 3 months, 6 months and every year up to 10 years after surgery
central cornea thickness (µm)
Time frame: up to 10 years after surgery
graft reject (yes/no), graft detachment (yes/no), graft failure (yes/no), eye infection (yes/no)
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Régional Metz-Thionville
Other
Prognosis of Posterior Lamellar Keratoplasty: an Observational Cohort Study
Acronym: CORNEACOHORT
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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