Predictive Factors of Good Results After Primary Descemet's Membrane Endothelial Keratoplasty (DMEK)

Study Overview
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Brief Summary
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Aim: Identify predictive factors of good results after primary Descemet's Membrane Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD). 82 patients (102 eyes) with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK between March 2016 and March 2018 were analyzed. Follow-up time was 12 months. The studied prognostic criteria were: pre-operative Central Corneal Thickness (CCT), CCT's delta between pre and D15 post-operatively, anterior mean keratometry, pre-operative endothelial cell density (ECD) and postoperative ECD at 6 and 12 months, pre-operative visual acuity, donors' and recipients' ages, recipients' sex, rebubbling and triple procedure (DMEK combined with cataract surgery).

Detailed Description
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Aim: Identify predictive factors of good results after primary Descemet's Membrane Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD). A monocentric retrospective observational study was realized at the Regional Hospital Center of Metz-Thionville, Mercy Hospital, Metz, France. 102 eyes of 82 patients with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK between March 2016 and March 2018 were analyzed. Follow-up time was 12 months. The studied prognostic criteria were: pre-operative Central Corneal Thickness (CCT), CCT's delta between pre and D15 post-operatively, anterior mean keratometry, pre-operative endothelial cell density (ECD) and postoperative ECD at 6 and 12 months, pre-operative visual acuity, donors' and recipients' ages, recipients' sex, rebubbling and triple procedure (DMEK combined with cataract surgery). Surgery was considered successful when best spectacle corrected visual acuity (BSCVA) was 0.1 logMar or less (≥0.8) 1 year postoperatively.

Official Title
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Predictive Factors of Good Results After Primary Descemet's Membrane Endothelial Keratoplasty (DMEK): Retrospective Study About 102 Eyes

Conditions
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Endothelial Corneal Dystrophy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18, had advanced FECD associated with visual symptoms and reduced visual acuity . Exclusion Criteria: Prior intraocular surgery other than cataract Other indications for DMEK surgeries than FECD, Eyes with corneal (except FECD), retinal or optic nerve diseases Per-operative difficulties (tear's graft or complicated unfolding graft) Primary graft failure (cornea that failed to clear in the presence of an attached graft) Secondary graft failure (corneal decompensation after an initial period of a functional graft)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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 |
| --- | --- | --- |
| Pre-operative Central Corneal Thickness (CCT), | Pre-operative CCT (μm) measured by an anterior segment optical coherence tomography (AS-OCT; RS-3000; Nidek Co. Ltd, Japan) | day 1 | 
| Post-operative Central Corneal Thickness (CCT), | Post-operative CCT (μm) measured by an anterior segment optical coherence tomography (AS-OCT; RS-3000; Nidek Co. Ltd, Japan) | Months 12 | 
| CCT's delta | CCT's delta (μm) between pre and D15 post-operatively | day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anterior mean keratometry | anterior mean keratometry (calculated by an auto keratometer Visionix Luneau L67, France) | day 1 | 
| pre-operative endothelial cell density ECD | pre-operative ECD (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan) | day1 | 
| post-operative endothelial cell density (ECD) | post-operative ECD at 6 months (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan) | 6 months | 
| post-operative endothelial cell density (ECD) | post-operative ECD at 12 months (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan) | 12 months | 
| pre-operative Visual Acuity | pre-operative Visual Acuity (using Monoyer chart and converted it to logMar scale) | day 1 | 
| donors' and recipients' ages | donors' and recipients' ages | day 1 | 
| recipients' sex | recipients' sex | day 1 | 
| rate of rebubbling | the rate of rebubbling %(postoperative graft detachment) | months 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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keratometry, Fuchs endothelial corneal dystrophy, central corneal thickness, endothelial cell density