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NCT Number: NCT04469933

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

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).

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Key information

Conditions

Endothelial Corneal Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Corneal endothelial dystrophy type 2 Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Pre-operative Central Corneal Thickness (CCT),

    Time frame: day 1

    Pre-operative CCT (μm) measured by an anterior segment optical coherence tomography (AS-OCT; RS-3000; Nidek Co. Ltd, Japan)

  2. Post-operative Central Corneal Thickness (CCT),

    Time frame: Months 12

    Post-operative CCT (μm) measured by an anterior segment optical coherence tomography (AS-OCT; RS-3000; Nidek Co. Ltd, Japan)

  3. CCT's delta

    Time frame: day 15

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

Secondary outcomes

  1. anterior mean keratometry

    Time frame: day 1

    anterior mean keratometry (calculated by an auto keratometer Visionix Luneau L67, France)

  2. pre-operative endothelial cell density ECD

    Time frame: day1

    pre-operative ECD (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)

  3. post-operative endothelial cell density (ECD)

    Time frame: 6 months

    post-operative ECD at 6 months (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)

  4. post-operative endothelial cell density (ECD)

    Time frame: 12 months

    post-operative ECD at 12 months (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)

  5. pre-operative Visual Acuity

    Time frame: day 1

    pre-operative Visual Acuity (using Monoyer chart and converted it to logMar scale)

  6. donors' and recipients' ages

    Time frame: day 1

    donors' and recipients' ages

  7. recipients' sex

    Time frame: day 1

    recipients' sex

  8. rate of rebubbling

    Time frame: months 6

    the rate of rebubbling %(postoperative graft detachment)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

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

Acronym: GOODRMEK

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 14, 2020
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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