Actively Recruiting
Led by Centre Hospitalier Régional Metz-Thionville · Updated on 2025-03-05
1000
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying the outcomes of two surgical techniques, DSAEK and DMEK, used to treat Fuchs' endothelial corneal dystrophy (FECD) and pseudophakic bullous keratopathy (PBK). These posterior lamellar keratoplasty methods have transformed management of these eye conditions by replacing damaged corneal layers with donor tissue. This observational cohort study aims to compare how patients' visual acuity changes after receiving either DMEK, DSAEK, or ultra-thin DSAEK grafts, along with secondary measures like endothelial cell density and corneal thickness. The study involves patients who have already received one of these three types of corneal transplants at Metz-Thionville Regional Hospital between 2012 and 2030. DSAEK involves grafts thicker than 160 microns, while UT-DSAEK uses thinner grafts, and DMEK transplants only the endothelium and Descemet's membrane. The donor grafts are prepared either at a tissue bank or during surgery. Data collection focuses on tracking visual acuity and other corneal health indicators over time. Participants will have their best spectacle-corrected visual acuity (BSCVA) measured repeatedly from day 8 up to 10 years after surgery, including at 1 year and annually thereafter. Endothelial cell density (ECD), central corneal thickness (CCT), and any post-operative complications will also be monitored at regular intervals over the same period. The study collects these data through observation without altering patient care, aiming to identify factors that predict outcomes and complications over the long term.
CONDITIONS
Prognosis of Posterior Lamellar Keratoplasty, an Observational Cohort Study
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus initial recovery period
Participants undergo posterior lamellar keratoplasty surgery and receive immediate post-operative care.
1 visit on day of surgery and visits at day 8 and day 15 post-surgery
Duration - Up to 10 years after surgery
Participants attend follow-up visits to monitor visual acuity, endothelial cell density, central corneal thickness, and any post-operative complications.
Visits at 1 month, 3 months, 6 months, and annually up to 10 years after surgery
Total: 1 location
1
CHR Metz-Thionville Hopital de Mercy
Metz, France, 57085
Actively Recruiting
A
Arpiné EL NAR, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Simon Delean, Christophe Goetz, Yinka Zevering...
https://pubmed.ncbi.nlm.nih.gov/41921039