Clinical trial NCT04424550: Comparative Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy
Official title: Comparative Long-term Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy and Moderated Pseudophakic Bullous Keratopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Dystrophy
Keywords: DMEK, DSAEK, UT-DSAEK, Endothelial cell
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This retrospective study included patients who had undergone posterior lamellar keratoplasty for FECD or moderate PBK indications with a minimum follow-up period of 24 months. The surgical procedures were either DMEK, DSAEK or UT-DSAEK and were performed by the same experienced surgeon (JMP).

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.

Eligibility criteria: Inclusion Criteria:

* Patients requiring posterior lamellar transplantation for FECD or moderate PBK, with preoperative BSCVA of less than 0.3 logmar,

Exclusion Criteria:

* Patients with pathologies that may seriously affect VA postoperatively

Primary outcomes:
measure: visual acuity
timeFrame: 6 months
measure: visual acuity
timeFrame: 12 months
measure: visual acuity
timeFrame: 24 months
Secondary outcomes:
measure: central graft thickness measurements
timeFrame: 6 months
measure: Type of endothelial graft
timeFrame: days 1
measure: Donor's ages
timeFrame: days 1
measure: recipient's ages
timeFrame: day 1
measure: Graft's endothelial cell density
timeFrame: day 1
measure: Rebubbling rate
timeFrame: day 1
measure: Preoperative visual acuity
timeFrame: day 1
measure: graft's indications
timeFrame: day 1
measure: surgical time
timeFrame: day 1
Other outcomes:
Locations:
city: Metz
country: France
facility: Chr Metz Thionville
Study officials:
affiliation: CHR Metz Thionville
name: Jean Marc PERONE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perone JM, Goetz C, Zevering Y, Derumigny A, Bloch F, Vermion JC, Lhuillier L. Graft Thickness at 6 Months Postoperatively Predicts Long-Term Visual Acuity Outcomes of Descemet Stripping Automated Endothelial Keratoplasty for Fuchs Dystrophy and Moderate Phakic Bullous Keratopathy: A Cohort Study. Cornea. 2022 Nov 1;41(11):1362-1371. doi: 10.1097/ICO.0000000000002872. Epub 2021 Oct 22.