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DMEK Versus DSAEK Study (DMEK)

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ClinicalTrials.gov Identifier: NCT02793310
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fuchs' Endothelial Dystrophy Procedure: DMEK Procedure: DSAEK Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Corneal Transplantation by DMEK - is it Really Better Than DSAEK?
Actual Study Start Date : October 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : February 2019

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: DMEK
The intervention group will receive cornea transplantation by DMEK
 Procedure: DMEK
The intervention group will receive cornea transplantation by DMEK
Active Comparator: DSAEK
The usual care / control group will receive cornea transplantation by DSAEK
 Procedure: DSAEK
The usual care / control group will receive cornea transplantation by DSAEK


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793310


Locations
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Netherlands
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: Rudy Nuijts, PhD Department of Ophthalmology, Maastricht University Medical Centre
More Information
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Additional Information:

Publications:

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02793310    
Other Study ID Numbers: NL55972.068.15
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Fuchs' Endothelial Dystrophy
Corneal Dystrophies, Hereditary
Corneal Diseases
 Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn