Fuchs' Endothelial DystrophyDMEKNCT02793310
DMEK Versus DSAEK Study
A study testing DMEK and DSAEK in people with Fuchs' Endothelial Dystrophy, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Fuchs' Endothelial Dystrophy
- What is being tested?
- DMEK and DSAEK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cornea decompensation caused Fuchs Endothelial Corneal Dystrophy
Who cannot join
- Ocular comorbidities other than cataract
- Previous corneal transplantation
- Human leukocyte antigen (HLA) matched keratoplasty
- Inability to complete follow-up
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6202 AZ
About this study
Official title: 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.
Read the 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.
- Conditions
- Fuchs' Endothelial Dystrophy
- Being tested
- DMEK, DSAEK
- Medical subject headings
- Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMEKProcedure or surgery
The intervention group will receive cornea transplantation by DMEK
DSAEKProcedure or surgery
The usual care / control group will receive cornea transplantation by DSAEK
| Study group | Role | What they receive |
|---|---|---|
| DMEK | Active comparator | The intervention group will receive cornea transplantation by DMEK Receives: Procedure: DMEK |
| DSAEK | Active comparator | The usual care / control group will receive cornea transplantation by DSAEK Receives: Procedure: DSAEK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in best-corrected visual acuity
Visual acuity will be measured by ETDRS letter charts
Measured: Preoperatively and 3, 6, 12 months post-operatively
Secondary outcomes (10)
Change in contrast sensitivity
Contrast sensitivity will be measured using the CSV-1000 chart by Vector Vision
Measured: Preoperatively and 3, 6, 12 months post-operatively
Change in astigmatism
Astigmatism will be measured using the The Pentacam HR (Oculus Inc., Lynnwood, USA)
Measured: Preoperatively and 3, 6, 12 months post-operatively
Change in corneal scatter
Corneal scatter will be measured using a confocal microscope
Measured: Preoperatively and 3, 6, 12 months post-operatively
Change in endothelial cell loss
Endothelial cell loss will be measured using specular microscopy photography.
Measured: Preoperatively and 3, 6, 12 months post-operatively
Incidence of graft rejection
Measured: 3, 6, 12 months post-operatively
Incidence of primary graft failure
Primary Graft failure will be assessed during ophthalmic examination.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Preoperatively and 3, 6, 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fuchs' Endothelial DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Rudy Nuijts, PhD, Principal investigator, Department of Ophthalmology, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793310
- Sponsor's protocol ID
- NL55972.068.15
- Acronym
- DMEK
- Status last verified
- Mar 2019
- First submitted
- 20 May 2016
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 24335068
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Transplantation by DMEK - is it Really Better Than DSAEK?
- ClinicalTrials.gov ID
- NCT02793310
- Acronym / sponsor ID
- DMEK / NL55972.068.15
- Conditions
- Fuchs' Endothelial Dystrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMEK | Active comparator | Procedure: DMEKThe intervention group will receive cornea transplantation by DMEK |
| DSAEK | Active comparator | Procedure: DSAEKThe usual care / control group will receive cornea transplantation by DSAEK |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cornea decompensation caused Fuchs Endothelial Corneal Dystrophy
Key exclusion criteria (4 listed)
- Ocular comorbidities other than cataract
- Previous corneal transplantation
- Human leukocyte antigen (HLA) matched keratoplasty
- Inability to complete follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMEKThe intervention group will receive cornea transplantation by DMEK | Procedure or surgery | DMEK |
| DSAEKThe usual care / control group will receive cornea transplantation by DSAEK | Procedure or surgery | DSAEK |
Primary outcome
Change in best-corrected visual acuity
Time frame: Preoperatively and 3, 6, 12 months post-operatively
Visual acuity will be measured by ETDRS letter charts
10 secondary outcomes
Change in contrast sensitivity
Time frame: Preoperatively and 3, 6, 12 months post-operatively
Change in astigmatism
Time frame: Preoperatively and 3, 6, 12 months post-operatively
Change in corneal scatter
Time frame: Preoperatively and 3, 6, 12 months post-operatively
Change in endothelial cell loss
Time frame: Preoperatively and 3, 6, 12 months post-operatively
Incidence of graft rejection
Time frame: 3, 6, 12 months post-operatively
Incidence of primary graft failure
Time frame: 3, 6, 12 months post-operatively
Incidence of cornea donor loss due to preparation
Time frame: Preoperatively
Change in generic quality of life
Time frame: Preoperatively and 3, 6, 12 months post-operatively
Change in generic quality of life
Time frame: Preoperatively and 3, 6, 12 months post-operatively
Change in vision-related quality of life
Time frame: Preoperatively and 3, 6, 12 months post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Background: PubMed 24335068Gipson 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.
- Nederlandse Orgaan Transplantatie Register (NOTR)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Fuchs' Endothelial Dystrophy
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
RecruitingPhase 2
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Fuchs
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
Enrolling by invitationObservational study
The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Cataract
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rudy Nuijts, PhD principal investigator
Department of Ophthalmology, Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DMEK and DSAEK in people with Fuchs' Endothelial Dystrophy, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in best-corrected visual acuity (time frame: Preoperatively and 3, 6, 12 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02793310, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.