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

C

Centre Hospitalier Régional Metz-Thionville

Status

Completed

Conditions

Endothelial Corneal Dystrophy

Study type

Observational

Funder types

Other

Identifiers

NCT04469933
2020-03ObsCHRMT

Details and patient eligibility

About

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).

Full 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.

Enrollment

102 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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