Clinical trial NCT04469933: Predictive Factors of Good Results After Primary Descemet's Membrane Endothelial Keratoplasty (DMEK)
Official title: Predictive Factors of Good Results After Primary Descemet's Membrane Endothelial Keratoplasty (DMEK): Retrospective Study About 102 Eyes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endothelial Corneal Dystrophy
Keywords: Fuchs endothelial corneal dystrophy
central corneal thickness
endothelial cell density
keratometry
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Included patients' were over 18, had advanced FECD associated with visual symptoms and reduced visual acuity

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pre-operative Central Corneal Thickness (CCT),
timeFrame: day 1
measure: Post-operative Central Corneal Thickness (CCT),
timeFrame: Months 12
measure: CCT's delta
timeFrame: day 15
Secondary outcomes:
measure: anterior mean keratometry
timeFrame: day 1
measure: pre-operative endothelial cell density ECD
timeFrame: day1
measure: post-operative endothelial cell density (ECD)
timeFrame: 6 months
measure: post-operative endothelial cell density (ECD)
timeFrame: 12 months
measure: pre-operative Visual Acuity
timeFrame: day 1
measure: donors' and recipients' ages
timeFrame: day 1
measure: recipients' sex
timeFrame: day 1
measure: rate of rebubbling
timeFrame: months 6
Other outcomes:
Locations:
Study officials:
affiliation: CHR Metz Thionville
name: Jean Marc PERONE, MD
role: PRINCIPAL_INVESTIGATOR
References: