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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04469933
Acronym
GOODRMEK
Enrollment
102
Registered
2020-07-14
Start date
2016-05-01
Completion date
2018-05-01
Last updated
2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Corneal Dystrophy

Keywords

Fuchs endothelial corneal dystrophy, central corneal thickness, endothelial cell density, keratometry

Brief summary

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

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.

Interventions

None listed

Sponsors

Centre Hospitalier Régional Metz-Thionville
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
pre-operative Visual Acuityday 1pre-operative Visual Acuity (using Monoyer chart and converted it to logMar scale)
donors' and recipients' agesday 1donors' and recipients' ages
anterior mean keratometryday 1anterior mean keratometry (calculated by an auto keratometer Visionix Luneau L67, France)
rate of rebubblingmonths 6the rate of rebubbling %(postoperative graft detachment)
recipients' sexday 1recipients' sex
pre-operative endothelial cell density ECDday1pre-operative ECD (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)
post-operative endothelial cell density (ECD)6 monthspost-operative ECD at 6 months (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026