Clinical trial NCT02793310: DMEK Versus DSAEK Study
Official title: Corneal Transplantation by DMEK - is it Really Better Than DSAEK?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fuchs' Endothelial Dystrophy
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2016-06-08
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in best-corrected visual acuity
timeFrame: Preoperatively and 3, 6, 12 months post-operatively
Secondary outcomes:
measure: Change in contrast sensitivity
timeFrame: Preoperatively and 3, 6, 12 months post-operatively
measure: Change in astigmatism
timeFrame: Preoperatively and 3, 6, 12 months post-operatively
measure: Change in corneal scatter
timeFrame: Preoperatively and 3, 6, 12 months post-operatively
measure: Change in endothelial cell loss
timeFrame: Preoperatively and 3, 6, 12 months post-operatively
measure: Incidence of graft rejection
timeFrame: 3, 6, 12 months post-operatively
measure: Incidence of primary graft failure
timeFrame: 3, 6, 12 months post-operatively
measure: Incidence of cornea donor loss due to preparation
timeFrame: Preoperatively
measure: Change in generic quality of life
timeFrame: Preoperatively and 3, 6, 12 months post-operatively
measure: Change in generic quality of life
timeFrame: Preoperatively and 3, 6, 12 months post-operatively
measure: Change in vision-related quality of life
timeFrame: Preoperatively and 3, 6, 12 months post-operatively
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Department of Ophthalmology, Maastricht University Medical Centre
name: Rudy Nuijts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.