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

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

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).

Study Overview

• Status: Completed
• Conditions: Endothelial Corneal Dystrophy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 102

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Included patients' were over 18, had advanced FECD associated with visual symptoms and reduced visual acuity

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: endothelial cell density; keratometry; central corneal thickness; Fuchs endothelial corneal dystrophy
• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Corneal Dystrophies, Hereditary
• Other Study ID Numbers: 2020-03ObsCHRMT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No