An interventional study of Phaco-DSAEK and Phaco-DMEK in Fuchs' Endothelial Dystrophy, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
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.
Hypotheses:
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.
92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.
This study's enrollment of 112 is above the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.
Browse Fuchs' Endothelial Dystrophy studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
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.
Procedure: Phaco-DSAEK
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.
Procedure: Phaco-DMEK
The intervention will be performed as a DSAEK triple-procedure with phacoemulsification and intraocular lens implantation prior to DSAEK.
The intervention will be performed as a DMEK triple-procedure with phacoemulsification and intraocular lens implantation prior to DMEK.
Best corrected visual acuity (BCVA)
BCVA will be measured using the early treatment diabetic retinopathy study (ETDRS) chart.
Time frame: 12 months
Cystoid macular edema
This will be quantified as central retinal thickness (µm) measured using optical coherence tomography (OCT) scans.
Time frame: 3 months
Largest pupil diameter (mm)
The pupil diameter will be measured using the pupillometer DP-2000, Neuroptics.
Time frame: 12 months
Iris contraction velocity (mm/s)
The contraction velocity will be measured using the pupillometer DP-2000, Neuroptics.
Time frame: 12 months
Circumpapillary Retinal Nerve Fibre Layer Thickness (cpRNFLT) (µm)
The cpRNFLT will be measured using OCT-scans.
Time frame: 12 months
Contrast-sensitivity (Weber contrast units)
This will be measured using the Freiburg Visual Acuity and Contrast Test (FrACT)
Time frame: 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.
Time frame: 12 months
Higher-order aberrations (HOA) (µm)
Measurements will be performed using Pentacam, Oculus. HOA will be quantified as the root mean square (RMS).
Time frame: 12 months
Epiretinal membrane (ERM) formation
Formation and changes will be assessed using OCT-scans.
Time frame: 12 months
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Fuchs' Endothelial Dystrophy →