Fuchs' Endothelial Dystrophy
Conditions
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.
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.
Interventions
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in best-corrected visual acuity | Preoperatively and 3, 6, 12 months post-operatively | Visual acuity will be measured by ETDRS letter charts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in astigmatism | Preoperatively and 3, 6, 12 months post-operatively | Astigmatism will be measured using the The Pentacam HR (Oculus Inc., Lynnwood, USA) |
| Change in corneal scatter | Preoperatively and 3, 6, 12 months post-operatively | Corneal scatter will be measured using a confocal microscope |
| Change in endothelial cell loss | Preoperatively and 3, 6, 12 months post-operatively | Endothelial cell loss will be measured using specular microscopy photography. |
| Incidence of graft rejection | 3, 6, 12 months post-operatively | — |
| Change in contrast sensitivity | Preoperatively and 3, 6, 12 months post-operatively | Contrast sensitivity will be measured using the CSV-1000 chart by Vector Vision |
| Incidence of cornea donor loss due to preparation | 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. |
| Change in generic quality of life | 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. |
| Change in vision-related quality of life | 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. |
| Incidence of primary graft failure | 3, 6, 12 months post-operatively | Primary Graft failure will be assessed during ophthalmic examination. |
Countries
Netherlands
Outcome results
None listed