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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02793310
Other study ID # NL55972.068.15
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date February 2019

Study information

Verified date March 2019
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date February 2019
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
DMEK
The intervention group will receive cornea transplantation by DMEK
DSAEK
The usual care / control group will receive cornea transplantation by DSAEK

Locations

Country Name City State
Netherlands Maastricht University Medical Centre Maastricht Limburg

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Medical Center ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in best-corrected visual acuity Visual acuity will be measured by ETDRS letter charts Preoperatively and 3, 6, 12 months post-operatively
Secondary 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
Secondary Change in astigmatism Astigmatism will be measured using the The Pentacam HR (Oculus Inc., Lynnwood, USA) Preoperatively and 3, 6, 12 months post-operatively
Secondary Change in corneal scatter Corneal scatter will be measured using a confocal microscope Preoperatively and 3, 6, 12 months post-operatively
Secondary Change in endothelial cell loss Endothelial cell loss will be measured using specular microscopy photography. Preoperatively and 3, 6, 12 months post-operatively
Secondary Incidence of graft rejection 3, 6, 12 months post-operatively
Secondary Incidence of primary graft failure Primary Graft failure will be assessed during ophthalmic examination. 3, 6, 12 months post-operatively
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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