Comparative Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Long-term Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy and Moderated Pseudophakic Bullous Keratopathy

Conditions
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Corneal Dystrophy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 6 months | 6 months | 
| visual acuity | The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 12 months | 12 months | 
| visual acuity | The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 24 months | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central graft thickness measurements | 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) | 6 months | 
| Type of endothelial graft | Type of endothelial graft | days 1 | 
| Donor's ages | Donor's ages | days 1 | 
| recipient's ages | recipient's ages | day 1 | 
| Graft's endothelial cell density | Graft's endothelial cell density was evaluated via no-contact specular microscopy (NIDEK CEM-530 NIDEK CO. LTD). | day 1 | 
| Rebubbling rate | Rebubbling rate | day 1 | 
| Preoperative visual acuity | Preoperative visual acuity was scored with reference to the logarithm of the minimum angle of resolution (LogMAR). | day 1 | 
| graft's indications | The indications of the grafts are different between the DMEK groups and the DSAEK and or UT-DSAEK groups: Fuchs endothelial corneal dystrophies (FECD) and moderated pseudophakic bullous keratopathies (PBK) | day 1 | 
| surgical time | surgical time | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DMEK, DSAEK, UT-DSAEK, Endothelial cell