Fuchs' Endothelial DystrophyNCT04417959
A Comparison of Visual Functions and Side-effects After DSAEK or DMEK for Fuchs' Endothelial Dystrophy
A study testing Phaco-DSAEK and Phaco-DMEK in people with Fuchs' Endothelial Dystrophy, run by University of Aarhus at 1 site in Denmark.
Trial summary
Descemet's stripping automated endothelial keratoplasty (DSAEK) and Descemet's membrane endothelial keratoplasty (DMEK) are becoming increasingly popular as treatments for Fuchs' endothelial dystrophy. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Fuchs' Endothelial Dystrophy
- What is being tested?
- Phaco-DSAEK and Phaco-DMEK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2020to 1 Sep 2025
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract and/or
- Fuch's endothelial dystrophy
Who cannot join
- Uveitis
- Diabetes mellitus
- Retinal vein occlusion
- Glaucoma
- Exudative age-related macular degeneration
- Advanced macular atrophy
- Ocular trauma
- Prior corneal grafting
Trial locations and contacts
1 site in 1 country.
About this study
Descemet's stripping automated endothelial keratoplasty (DSAEK) and Descemet's membrane endothelial keratoplasty (DMEK) are becoming increasingly popular as treatments for Fuchs' endothelial dystrophy. However, despite several years of use the incidence of cystoid macular edema and damage related to increased intraocular pressure (IOP), and the forward scattering of light through the eye following DSAEK or DMEK have to our knowledge not been prospectively described. Therefore, this project will be a randomized controlled trial investigating these matters.
Read the detailed description
Purpose:
To investigate 3 different side-effects after DSAEK, DMEK, and cataract extraction (CE) in a randomized controlled trial with 12 months follow-up with CE as an additional control group.
- To investigate the extend of subclinical cystoid macular edema (CME) and epiretinal membrane (ERM) after DSAEK, DMEK, and CE.
- To investigate IOP-related changes after DSAEK, DMEK, and CE in means of pupil diameter and cpRNFLT. Further, to describe iris alterations including Urrets-Zavalia Syndrome (UZS).
- To compare the difference in forward scatter, visual acuity (VA), and low-contrast VA after DSAEK, DMEK, and CE and relate this to the best corrected visual acuity (BCVA). Further, to investigate changes in higher-order aberrations, patient reported outcome measures (PROM), and total corneal refraction after the procedures.
Hypotheses:
- Subclinical CME and ERM are adverse effects that occur equally often following DSAEK, DMEK, and CE.
- Following DSAEK, DMEK, and CE, there are no differences in the amount of IOP-related changes in means of pupil diameter,cpRNFLT thinning or iris alterations.
- Changes in OSI, HOA, PROM, VA, contrast sensitivity, and total corneal refraction occur to the same extend after DSAEK, DMEK, and CE.
Materials and Methods:
Patients referred to the Department of Ophthalmology at Aarhus University Hospital (AUH) for EK or CE will be assessed in order to identify suitable study subjects.
Only patients with primary endothelial failure (Fuchs endothelial dystrophy) and a concomitant need for CE will be considered eligible for randomization to either the DSAEK or the DMEK study groups. Patients included in the study will be randomized 1:1 to the DSAEK or DMEK study groups. Patients referred for CE will be offered to participate in the project and will be included in the CE group. Based on power calculations, it is planned to include 40 patients in each of the 3 groups.
Subject and donor characteristics will be gathered. Subjects with prior uveitis, severe vitreous opacities, diabetes, retinal vein occlusion, glaucoma, age-related macular degeneration, macular atrophy, trauma or corneal grafting will be excluded from the study. Data collection will be conducted at AUH before the interventions and in the follow-up period.
Donor tissue will be prepared in the Danish Cornea Bank, either pre-pealed for DMEK or pre-cut for DSAEK.
Measurements as described below will be conducted both prior to the surgical intervention and 3, 6, and 12 months after this.
Patients lost to follow-up during the project will only be used for analysis at the time-point they have attended. Therefore, for all time-points after the loss to follow-up these subjects will be excluded from our investigation.
In case of capsule rupture where the intraocular lens still is positioned into the lens bag during CE or if rebubbling is needed after DSAEK or DMEK, the subjects will still be eligible for further participation in the project. Adverse events such as primary graft failure or rejection is considered to be rare events for both DSAEK and DMEK and subjects with these will be excluded from our final estimates.
- Conditions
- Fuchs' Endothelial Dystrophy
- Being tested
- Phaco-DSAEK, Phaco-DMEK
- 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.
Phaco-DSAEKProcedure or surgery
The intervention will be performed as a DSAEK triple-procedure with phacoemulsification and intraocular lens implantation prior to DSAEK.
Phaco-DMEKProcedure or surgery
The intervention will be performed as a DMEK triple-procedure with phacoemulsification and intraocular lens implantation prior to DMEK.
| Study group | Role | What they receive |
|---|---|---|
| Phaco-DSAEK | Other | Subjects randomized to this arm will consist of patients with both Fuchs' endothelial dystrophy and cataract. These will be treated with phacoemulsification and Descemet's stripping automated endothelial keratoplasty. Receives: Procedure: Phaco-DSAEK |
| Phaco-DMEK | Other | Subjects randomized to this arm will consist of patients with both Fuchs' endothelial dystrophy and cataract. These will be treated with phacoemulsification and Descemet's membrane endothelial keratoplasty. Receives: Procedure: Phaco-DMEK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity (BCVA)
BCVA will be measured using the early treatment diabetic retinopathy study (ETDRS) chart.
Measured: 12 months
Secondary outcomes (7)
Cystoid macular edema
This will be quantified as central retinal thickness (µm) measured using optical coherence tomography (OCT) scans.
Measured: 3 months
Largest pupil diameter (mm)
The pupil diameter will be measured using the pupillometer DP-2000, Neuroptics.
Measured: 12 months
Iris contraction velocity (mm/s)
The contraction velocity will be measured using the pupillometer DP-2000, Neuroptics.
Measured: 12 months
Circumpapillary Retinal Nerve Fibre Layer Thickness (cpRNFLT) (µm)
The cpRNFLT will be measured using OCT-scans.
Measured: 12 months
Contrast-sensitivity (Weber contrast units)
This will be measured using the Freiburg Visual Acuity and Contrast Test (FrACT)
Measured: 12 months
Forward light scatter
Forward light scatter will be measured using the HD Analyzer, Optical Quality Analysis System (OQAS), Visiometrics. The forward light scatter will be assessed using the objective scattering index (OSI). This system evaluates the intraocular scattering of light.
Measured: 12 months
Higher-order aberrations (HOA) (µm)
Measurements will be performed using Pentacam, Oculus. HOA will be quantified as the root mean square (RMS).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2022
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Model description
- Study subjects with the requirement for endothelial keratoplasty and a concomitant need for cataract extraction will be randomized 1:1 to either phaco-DSAEK or phaco-DMEK. Further, a third group consisting of sujects with a solely need for cataract extraction will be included as a control group in our study. The three groups will be prospectively followed.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417959
- Sponsor's protocol ID
- AUH_øjensygdomme_DSAEK_vs_DMEK
- Status last verified
- Apr 2026
- First submitted
- 2 Jun 2020
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Madsen MBM, Ivarsen A, Hjortdal J. Optical quality after ultrathin Descemet's stripping automated endothelial keratoplasty and Descemet's membrane endothelial keratoplasty: a randomised controlled clinical trial. Br J Ophthalmol. 2026 May 20;110(6):607-614. doi: 10.1136/bjo-2025-328970.
PubMed 41381122Madsen MBM, Ivarsen A, Hjortdal J. Visual function after ultrathin Descemet's stripping automated endothelial keratoplasty or Descemet's membrane endothelial keratoplasty combined with cataract surgery: a randomised controlled clinical trial. Br J Ophthalmol. 2024 May 21;108(5):654-661. doi: 10.1136/bjo-2023-323304.
PubMed 37290822Molbech Madsen MB, Ivarsen A, Hjortdal J. Macular Thickness After Ultrathin Descemet Stripping Automated Endothelial Keratoplasty and Descemet Membrane Endothelial Keratoplasty Combined With Cataract Surgery: A Randomized Controlled Clinical Trial. Cornea. 2023 Dec 1;42(12):1536-1543. doi: 10.1097/ICO.0000000000003256. Epub 2023 Feb 24.
PubMed 36853598
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Visual Functions and Side-effects After DSAEK or DMEK for Fuchs' Endothelial Dystrophy
- ClinicalTrials.gov ID
- NCT04417959
- Acronym / sponsor ID
- AUH_øjensygdomme_DSAEK_vs_DMEK
- Conditions
- Fuchs' Endothelial Dystrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 5 Jun 2020 (actual)
- 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.
Descemet's stripping automated endothelial keratoplasty (DSAEK) and Descemet's membrane endothelial keratoplasty (DMEK) are becoming increasingly popular as treatments for Fuchs' endothelial dystrophy. However, despite several years of use the incidence of cystoid macular edema and damage related to increased intraocular pressure (IOP), and the forward scattering of light through the eye following DSAEK or DMEK have to our knowledge not been prospectively described. Therefore, this project will be a randomized controlled trial investigating these matters.
Detailed description
Purpose:
To investigate 3 different side-effects after DSAEK, DMEK, and cataract extraction (CE) in a randomized controlled trial with 12 months follow-up with CE as an additional control group.
- To investigate the extend of subclinical cystoid macular edema (CME) and epiretinal membrane (ERM) after DSAEK, DMEK, and CE.
- To investigate IOP-related changes after DSAEK, DMEK, and CE in means of pupil diameter and cpRNFLT. Further, to describe iris alterations including Urrets-Zavalia Syndrome (UZS).
- To compare the difference in forward scatter, visual acuity (VA), and low-contrast VA after DSAEK, DMEK, and CE and relate this to the best corrected visual acuity (BCVA). Further, to investigate changes in higher-order aberrations, patient reported outcome measures (PROM), and total corneal refraction after the procedures.
Hypotheses:
- Subclinical CME and ERM are adverse effects that occur equally often following DSAEK, DMEK, and CE.
- Following DSAEK, DMEK, and CE, there are no differences in the amount of IOP-related changes in means of pupil diameter,cpRNFLT thinning or iris alterations.
- Changes in OSI, HOA, PROM, VA, contrast sensitivity, and total corneal refraction occur to the same extend after DSAEK, DMEK, and CE.
Materials and Methods:
Patients referred to the Department of Ophthalmology at Aarhus University Hospital (AUH) for EK or CE will be assessed in order to identify suitable study subjects.
Only patients with primary endothelial failure (Fuchs endothelial dystrophy) and a concomitant need for CE will be considered eligible for randomization to either the DSAEK or the DMEK study groups. Patients included in the study will be randomized 1:1 to the DSAEK or DMEK study groups. Patients referred for CE will be offered to participate in the project and will be included in the CE group. Based on power calculations, it is planned to include 40 patients in each of the 3 groups.
Subject and donor characteristics will be gathered. Subjects with prior uveitis, severe vitreous opacities, diabetes, retinal vein occlusion, glaucoma, age-related macular degeneration, macular atrophy, trauma or corneal grafting will be excluded from the study. Data collection will be conducted at AUH before the interventions and in the follow-up period.
Donor tissue will be prepared in the Danish Cornea Bank, either pre-pealed for DMEK or pre-cut for DSAEK.
Measurements as described below will be conducted both prior to the surgical intervention and 3, 6, and 12 months after this.
Patients lost to follow-up during the project will only be used for analysis at the time-point they have attended. Therefore, for all time-points after the loss to follow-up these subjects will be excluded from our investigation.
In case of capsule rupture where the intraocular lens still is positioned into the lens bag during CE or if rebubbling is needed after DSAEK or DMEK, the subjects will still be eligible for further participation in the project. Adverse events such as primary graft failure or rejection is considered to be rare events for both DSAEK and DMEK and subjects with these will be excluded from our final estimates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Study subjects with the requirement for endothelial keratoplasty and a concomitant need for cataract extraction will be randomized 1:1 to either phaco-DSAEK or phaco-DMEK. Further, a third group consisting of sujects with a solely need for cataract extraction will be included as a control group in our study. The three groups will be prospectively followed.
| Arm | Type | Receives |
|---|---|---|
| Phaco-DSAEK | Other | Procedure: Phaco-DSAEKSubjects randomized to this arm will consist of patients with both Fuchs' endothelial dystrophy and cataract. These will be treated with phacoemulsification and Descemet's stripping automated endothelial keratoplasty. |
| Phaco-DMEK | Other | Procedure: Phaco-DMEKSubjects randomized to this arm will consist of patients with both Fuchs' endothelial dystrophy and cataract. These will be treated with phacoemulsification and Descemet's membrane endothelial keratoplasty. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cataract and/or
- Fuch's endothelial dystrophy
Key exclusion criteria (8 listed)
- Uveitis
- Diabetes mellitus
- Retinal vein occlusion
- Glaucoma
- Exudative age-related macular degeneration
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 |
|---|---|---|
| Phaco-DSAEKThe intervention will be performed as a DSAEK triple-procedure with phacoemulsification and intraocular lens implantation prior to DSAEK. | Procedure or surgery | Phaco-DSAEK |
| Phaco-DMEKThe intervention will be performed as a DMEK triple-procedure with phacoemulsification and intraocular lens implantation prior to DMEK. | Procedure or surgery | Phaco-DMEK |
Primary outcome
Best corrected visual acuity (BCVA)
Time frame: 12 months
BCVA will be measured using the early treatment diabetic retinopathy study (ETDRS) chart.
7 secondary outcomes
Cystoid macular edema
Time frame: 3 months
Largest pupil diameter (mm)
Time frame: 12 months
Iris contraction velocity (mm/s)
Time frame: 12 months
Circumpapillary Retinal Nerve Fibre Layer Thickness (cpRNFLT) (µm)
Time frame: 12 months
Contrast-sensitivity (Weber contrast units)
Time frame: 12 months
Forward light scatter
Time frame: 12 months
Higher-order aberrations (HOA) (µm)
Time frame: 12 months
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 29 Apr 2026.
- Derived from this study: PubMed 41381122Madsen MBM, Ivarsen A, Hjortdal J. Optical quality after ultrathin Descemet's stripping automated endothelial keratoplasty and Descemet's membrane endothelial keratoplasty: a randomised controlled clinical trial. Br J Ophthalmol. 2026 May 20;110(6):607-614. doi: 10.1136/bjo-2025-328970.
- Derived from this study: PubMed 37290822Madsen MBM, Ivarsen A, Hjortdal J. Visual function after ultrathin Descemet's stripping automated endothelial keratoplasty or Descemet's membrane endothelial keratoplasty combined with cataract surgery: a randomised controlled clinical trial. Br J Ophthalmol. 2024 May 21;108(5):654-661. doi: 10.1136/bjo-2023-323304.
- Derived from this study: PubMed 36853598Molbech Madsen MB, Ivarsen A, Hjortdal J. Macular Thickness After Ultrathin Descemet Stripping Automated Endothelial Keratoplasty and Descemet Membrane Endothelial Keratoplasty Combined With Cataract Surgery: A Randomized Controlled Clinical Trial. Cornea. 2023 Dec 1;42(12):1536-1543. doi: 10.1097/ICO.0000000000003256. Epub 2023 Feb 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phaco-DSAEK and Phaco-DMEK in people with Fuchs' Endothelial Dystrophy, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 8 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 29 Apr 2026. 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 Denmark. 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?
Best corrected visual acuity (BCVA) (time frame: 12 months). 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 NCT04417959, which also lists 3 linked publications.
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 29 Apr 2026.