DMEK Versus DSAEK Study (DMEK)

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

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.

Study Overview

• Status: Completed
• Conditions: Fuchs' Endothelial Dystrophy
• Intervention / Treatment: Procedure: DMEK; Procedure: DSAEK

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6202 AZ
      • Maastricht University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Rudy Nuijts, PhD, Department of Ophthalmology, Maastricht University Medical Centre

Publications and helpful links

General Publications

• 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.

Helpful Links

• Nederlandse Orgaan Transplantatie Register (NOTR)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: May 20, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimate): June 8, 2016

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: NL55972.068.15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided