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Completed

NCT Number: NCT02793310

DMEK Versus DSAEK Study

The purpose of this study is to determine whether corneal transplantation by Descemet Membrane Endothelial Keratoplasty more favourable and cost-effective is compared to Descemet Stripping Automated Endothelial Keratoplasty for Fuchs Endothelium Corneal Dystrophy.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Centre

Maastricht, Limburg, 6202 AZ, Netherlands

About this study

FECD is a progressive, multifactorial and irreversible disease characterized by accelerated loss of corneal endothelial cells in the innermost layer of the cornea that leads to vision impairment and potential blindness if left untreated. FECD is responsible for more than 50% of the 1.300 annual corneal transplantations in the Netherlands.

Corneal transplantation improves vision and quality of life in patients with corneal disease. Currently, the standard of care for patients with Fuchs Endothelial Corneal Dystrophy (FECD) is Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), in which only the posterior layers of the cornea are transplanted. However, visual recovery following DSAEK is suboptimal. Descemet Membrane Endothelial Keratoplasty (DMEK), the latest technique in corneal transplantation involves transplantation of only a monolayer of corneal endothelium and Descemet's membrane providing the thinnest endothelial graft possible. DMEK has been suggested to result in faster and better visual recovery compared to DSAEK. While the economic burden, both medical and social, from this disease has not been assessed to date, costs associated with corneal transplantation reach $ 110 million dollars yearly for the 47.000 transplantations in the USA.

The objective of this project is to assess the effects and costs of DMEK vs. DSAEK in order to determine whether the new technique is effective and cost-effective over the standard technique.

The primary outcome measure is best-corrected visual acuity. Secondary outcome measures are contrast acuity, astigmatism, quality of vision, endothelial cell loss, incidence of graft rejection, primary graft failure, cornea donor loss due to preparation, and generic and vision-related quality of life.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Cornea decompensation caused Fuchs Endothelial Corneal Dystrophy

Exclusion criteria

  • Ocular comorbidities other than cataract
  • Previous corneal transplantation
  • Human leukocyte antigen (HLA) matched keratoplasty
  • Inability to complete follow-up

Treatment and study plan

DMEK

Procedure

The intervention group will receive cornea transplantation by DMEK

DSAEK

Procedure

The usual care / control group will receive cornea transplantation by DSAEK

Primary outcomes

  1. Change in best-corrected visual acuity

    Time frame: Preoperatively and 3, 6, 12 months post-operatively

    Visual acuity will be measured by ETDRS letter charts

Secondary outcomes

  1. Change in contrast sensitivity

    Time frame: Preoperatively and 3, 6, 12 months post-operatively

    Contrast sensitivity will be measured using the CSV-1000 chart by Vector Vision

  2. Change in astigmatism

    Time frame: Preoperatively and 3, 6, 12 months post-operatively

    Astigmatism will be measured using the The Pentacam HR (Oculus Inc., Lynnwood, USA)

  3. Change in corneal scatter

    Time frame: Preoperatively and 3, 6, 12 months post-operatively

    Corneal scatter will be measured using a confocal microscope

  4. Change in endothelial cell loss

    Time frame: Preoperatively and 3, 6, 12 months post-operatively

    Endothelial cell loss will be measured using specular microscopy photography.

  5. Incidence of graft rejection

    Time frame: 3, 6, 12 months post-operatively

  6. Incidence of primary graft failure

    Time frame: 3, 6, 12 months post-operatively

    Primary Graft failure will be assessed during ophthalmic examination.

  7. Incidence of cornea donor loss due to preparation

    Time frame: Preoperatively

    The eye bank providing the donor cornea's will register cornea donor loss if a complication occurs during preparation that renders the cornea unusable.

  8. Change in generic quality of life

    Time frame: Preoperatively and 3, 6, 12 months post-operatively

    Generic quality of life will be measured using the HUI3 (Health Utility Index Mark 3), which test 8 dimensions: vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain.

  9. Change in generic quality of life

    Time frame: Preoperatively and 3, 6, 12 months post-operatively

    Generic quality of life will be measured using the EQ-5D-5L questionnaire, which tests 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

  10. Change in vision-related quality of life

    Time frame: Preoperatively and 3, 6, 12 months post-operatively

    Vision-related quality of life will be measured using the National Eye Institute Visual Function Questionnaire (NEI VFQ-25), which is specified for vision-related quality of life.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

Corneal Transplantation by DMEK - is it Really Better Than DSAEK?

Acronym: DMEK

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2016
Registry last updated
Mar 7, 2019

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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