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

NCT04469933 | Completed

• 1 other identifier: 2020-03ObsCHRMT
• Study Type: observational
• Target: 102
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Endothelial Corneal Dystrophy

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• CCT's delta

  CCT's delta (μm) between pre and D15 post-operatively

  day 15

Secondary Outcomes (8)

• anterior mean keratometry

  day 1

• pre-operative endothelial cell density ECD

  day1

• post-operative endothelial cell density (ECD)

  6 months

• post-operative endothelial cell density (ECD)

  12 months

• pre-operative Visual Acuity

  day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Included patients' were over 18, had advanced FECD associated with visual symptoms and reduced visual acuity

You may qualify if:

• Over 18,
• had advanced FECD associated with visual symptoms and reduced visual acuity .

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

MeSH Terms

Conditions

Corneal endothelial dystrophy type 2; Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jean Marc PERONE, MD

  CHR Metz Thionville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 14, 2020
• Study Start: May 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: July 14, 2020

Record last verified: 2020-06