DMEK Versus DSAEK Study
DMEK
Corneal Transplantation by DMEK - is it Really Better Than DSAEK?
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2016
CompletedFirst Posted
Study publicly available on registry
June 8, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedMarch 7, 2019
March 1, 2019
2.3 years
May 20, 2016
March 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in best-corrected visual acuity
Visual acuity will be measured by ETDRS letter charts
Preoperatively and 3, 6, 12 months post-operatively
Secondary Outcomes (10)
Change in contrast sensitivity
Preoperatively and 3, 6, 12 months post-operatively
Change in astigmatism
Preoperatively and 3, 6, 12 months post-operatively
Change in corneal scatter
Preoperatively and 3, 6, 12 months post-operatively
Change in endothelial cell loss
Preoperatively and 3, 6, 12 months post-operatively
Incidence of graft rejection
3, 6, 12 months post-operatively
- +5 more secondary outcomes
Study Arms (2)
DMEK
ACTIVE COMPARATORThe intervention group will receive cornea transplantation by DMEK
DSAEK
ACTIVE COMPARATORThe usual care / control group will receive cornea transplantation by DSAEK
Interventions
Eligibility Criteria
You may qualify if:
- Cornea decompensation caused Fuchs Endothelial Corneal Dystrophy
You may not qualify if:
- Ocular comorbidities other than cataract
- Previous corneal transplantation
- Human leukocyte antigen (HLA) matched keratoplasty
- Inability to complete follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University Medical Centre
Maastricht, Limburg, 6202 AZ, Netherlands
Related 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.
PMID: 24335068BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rudy Nuijts, PhD
Department of Ophthalmology, Maastricht University Medical Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2016
First Posted
June 8, 2016
Study Start
October 1, 2016
Primary Completion
January 1, 2019
Study Completion
February 1, 2019
Last Updated
March 7, 2019
Record last verified: 2019-03