Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
Study NCT ID:
NCT04424550
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2020-06-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy
Sponsor:
Centre Hospitalier Régional Metz-Thionville
Organization:
Study Overview
Official Title:
Comparative Long-term Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy and Moderated Pseudophakic Bullous Keratopathy
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEMOGRAFT
Brief Summary:
Purpose of the research is to describe and compare the evolution of BSCVA after DMEK, DSAEK and UT-DSAEK for Fuchs Endothelial Corneal Dystrophy (FECD) and Moderate Pseudophakic Bullous Keratopathy (PBK). To secondarily research the correlates criterions with best spectacle corrected visual acuity (BSCVA) 12 months postoperatively.
Detailed Description:
The purpose of the research is to Describe and compare the evolution of BSCVA after DMEK, DSAEK and UT-DSAEK for Fuchs Endothelial Corneal Dystrophy (FECD) and Moderate Pseudophakic Bullous Keratopathy (PBK). To secondarily research the correlates criterions with best spectacle corrected visual acuity (BSCVA) 12 months postoperatively.
In a retrospective, single-center, observational study, 218 eyes treated with DMEK (n=110), UT-DSAEK (n=58) and DSAEK (n=50) surgeries were studied. Patients requiring posterior lamellar transplantation for FECD or moderate PBK, with preoperative BSCVA of less than 0.3 logmar, were selected. Patients with pathologies that may seriously affect VA postoperatively were excluded. Graft thickness for DSAEK was measured during the surgery and in vivo at D8, D15, M1, M6, M12 and M24. The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 6, 12 and 24 months. We deliberately differentiated our postoperative visual results by comparing DMEK with DSAEK or UT-DSAEK with central graft thickness (CGT) measurements carried out either pre-operatively (less than or greater than 130 µm) or post-operatively at 6 months (less than or greater than 100µm). Type of endothelial graft, Donor and recipient's ages, Graft's endothelial cell density (ECD), Rebubbling rate, preoperative VA, graft's indications and surgical time were also tested to explain BSCVA at 12 months.
In a retrospective, single-center, observational study, 218 eyes treated with DMEK (n=110), UT-DSAEK (n=58) and DSAEK (n=50) surgeries were studied. Patients requiring posterior lamellar transplantation for FECD or moderate PBK, with preoperative BSCVA of less than 0.3 logmar, were selected. Patients with pathologies that may seriously affect VA postoperatively were excluded. Graft thickness for DSAEK was measured during the surgery and in vivo at D8, D15, M1, M6, M12 and M24. The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 6, 12 and 24 months. We deliberately differentiated our postoperative visual results by comparing DMEK with DSAEK or UT-DSAEK with central graft thickness (CGT) measurements carried out either pre-operatively (less than or greater than 130 µm) or post-operatively at 6 months (less than or greater than 100µm). Type of endothelial graft, Donor and recipient's ages, Graft's endothelial cell density (ECD), Rebubbling rate, preoperative VA, graft's indications and surgical time were also tested to explain BSCVA at 12 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: