DMEK Versus DSAEK Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Fuchs' Endothelial Dystrophy

Intervention / Treatment
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* Procedure: DMEK
* Procedure: DSAEK


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DMEK<br>The intervention group will receive cornea transplantation by DMEK | Procedure: DMEK<br>* The intervention group will receive cornea transplantation by DMEK<br>|
| Active Comparator: DSAEK<br>The usual care / control group will receive cornea transplantation by DSAEK | Procedure: DSAEK<br>* The usual care / control group will receive cornea transplantation by DSAEK<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in best-corrected visual acuity | Visual acuity will be measured by ETDRS letter charts | Preoperatively and 3, 6, 12 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in contrast sensitivity | Contrast sensitivity will be measured using the CSV-1000 chart by Vector Vision | Preoperatively and 3, 6, 12 months post-operatively | 
| Change in astigmatism | Astigmatism will be measured using the The Pentacam HR (Oculus Inc., Lynnwood, USA) | Preoperatively and 3, 6, 12 months post-operatively | 
| Change in corneal scatter | Corneal scatter will be measured using a confocal microscope | Preoperatively and 3, 6, 12 months post-operatively | 
| Change in endothelial cell loss | Endothelial cell loss will be measured using specular microscopy photography. | Preoperatively and 3, 6, 12 months post-operatively | 
| Incidence of graft rejection |  | 3, 6, 12 months post-operatively | 
| Incidence of primary graft failure | Primary Graft failure will be assessed during ophthalmic examination. | 3, 6, 12 months post-operatively | 
| Incidence of cornea donor loss due to preparation | The eye bank providing the donor cornea's will register cornea donor loss if a complication occurs during preparation that renders the cornea unusable. | Preoperatively | 
| Change in generic quality of life | 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. | Preoperatively and 3, 6, 12 months post-operatively | 
| Change in generic quality of life | 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. | Preoperatively and 3, 6, 12 months post-operatively | 
| Change in vision-related quality of life | 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. | Preoperatively and 3, 6, 12 months post-operatively |