Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2016-10-31
2019-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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DMEK
The intervention group will receive cornea transplantation by DMEK
DMEK
The intervention group will receive cornea transplantation by DMEK
DSAEK
The usual care / control group will receive cornea transplantation by DSAEK
DSAEK
The usual care / control group will receive cornea transplantation by DSAEK
Interventions
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DMEK
The intervention group will receive cornea transplantation by DMEK
DSAEK
The usual care / control group will receive cornea transplantation by DSAEK
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous corneal transplantation
* Human leukocyte antigen (HLA) matched keratoplasty
* Inability to complete follow-up
21 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Rudy Nuijts, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Ophthalmology, Maastricht University Medical Centre
Locations
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Maastricht University Medical Centre
Maastricht, Limburg, Netherlands
Countries
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References
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Gipson IK. Age-related changes and diseases of the ocular surface and cornea. Invest Ophthalmol Vis Sci. 2013 Dec 13;54(14):ORSF48-53. doi: 10.1167/iovs.13-12840.
Related Links
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Nederlandse Orgaan Transplantatie Register (NOTR)
Other Identifiers
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NL55972.068.15
Identifier Type: -
Identifier Source: org_study_id
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