Prognosis of Posterior Lamellar Keratoplasty, an Observational Cohort Study
NCT ID: NCT06859411
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
1000 participants
OBSERVATIONAL
2024-06-01
2040-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
NCT02020044
Visual Outcomes Following Descemet Stripping Automated Endothelial Keratoplasty
NCT03685734
Preoperative Corneal Thickness and Postoperative Visual Outcomes After Posterior Lamellar Corneal Transplant
NCT03355911
Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy
NCT06425666
Technique And Results In Endothelial Keratoplasty
NCT02470793
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DMEK
Patients who received Descemet Membrane Endothelial Keratoplasty
visual acuity comparaison
Data collection
DSAEK
Patients who received Descemet Stripping Automated Endothelial Keratoplasty with preoperative graft thicker than 160 µm
visual acuity comparaison
Data collection
UT-DSAEK
DSAEK: patients who received Descemet Stripping Automated Endothelial Keratoplasty with preoperative graft thinner than 160 µm
visual acuity comparaison
Data collection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
visual acuity comparaison
Data collection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Régional Metz-Thionville
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean-Marc PERONE, MD
Role: PRINCIPAL_INVESTIGATOR
CHR Metz Thionville Hopital de Mercy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHR Metz-Thionville Hopital de Mercy
Metz, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-11Obs-CHRMT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.