DMEK Versus DSAEK Study

Fuchs' Endothelial Dystrophy Clinical Trial

— DMEK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793310
• Other study ID #: NL55972.068.15
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fuchs' Endothelial Dystrophy

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

External Links

•   Nederlandse Orgaan Transplantatie Register (NOTR)