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

Endothelial Corneal Dystrophy Clinical Trial

— GOODRMEK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04469933
• Other study ID #: 2020-03ObsCHRMT
• Status: Completed
• Start date: May 1, 2016
• Est. completion date: May 1, 2018

Study information

• Verified date: June 2020
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Endothelial Corneal Dystrophy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	CCT's delta	CCT's delta (µm) between pre and D15 post-operatively	day 15
Secondary	anterior mean keratometry	anterior mean keratometry (calculated by an auto keratometer Visionix Luneau L67, France)	day 1
Secondary	pre-operative endothelial cell density ECD	pre-operative ECD (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)	day1
Secondary	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
Secondary	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
Secondary	pre-operative Visual Acuity	pre-operative Visual Acuity (using Monoyer chart and converted it to logMar scale)	day 1
Secondary	donors' and recipients' ages	donors' and recipients' ages	day 1
Secondary	recipients' sex	recipients' sex	day 1
Secondary	rate of rebubbling	the rate of rebubbling %(postoperative graft detachment)	months 6