Predictive Factors of Good Results After Primary Descemet's Membrane Endothelial Keratoplasty (DMEK)
NCT ID: NCT04469933
Last Updated: 2020-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
102 participants
OBSERVATIONAL
2016-05-01
2018-05-01
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* had advanced FECD associated with visual symptoms and reduced visual acuity .
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Centre Hospitalier Régional Metz-Thionville
OTHER
Responsible Party
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Principal Investigators
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Jean Marc PERONE, MD
Role: PRINCIPAL_INVESTIGATOR
CHR Metz Thionville
Other Identifiers
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2020-03ObsCHRMT
Identifier Type: -
Identifier Source: org_study_id
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