- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04417959
A Comparison of Visual Functions and Side-effects After DSAEK or DMEK for Fuchs' Endothelial Dystrophy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Region Midtjylland
-
Aarhus, Region Midtjylland, Denmark, 8200
- Department of Ophthalmology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Cataract and/or
- Fuch's endothelial dystrophy
Exclusion Criteria:
- Uveitis
- Diabetes mellitus
- Retinal vein occlusion
- Glaucoma
- Exudative age-related macular degeneration
- Advanced macular atrophy
- Ocular trauma
- Prior corneal grafting
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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 stripping automated endothelial keratoplasty.
|
The intervention will be performed as a DSAEK triple-procedure with phacoemulsification and intraocular lens implantation prior to DSAEK.
|
Other: Phaco-DMEK
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.
|
The intervention will be performed as a DMEK triple-procedure with phacoemulsification and intraocular lens implantation prior to DMEK.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best corrected visual acuity (BCVA)
Time Frame: 12 months
|
BCVA will be measured using the early treatment diabetic retinopathy study (ETDRS) chart.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cystoid macular edema
Time Frame: 3 months
|
This will be quantified as central retinal thickness (µm) measured using optical coherence tomography (OCT) scans.
|
3 months
|
Largest pupil diameter (mm)
Time Frame: 12 months
|
The pupil diameter will be measured using the pupillometer DP-2000, Neuroptics.
|
12 months
|
Iris contraction velocity (mm/s)
Time Frame: 12 months
|
The contraction velocity will be measured using the pupillometer DP-2000, Neuroptics.
|
12 months
|
Circumpapillary Retinal Nerve Fibre Layer Thickness (cpRNFLT) (µm)
Time Frame: 12 months
|
The cpRNFLT will be measured using OCT-scans.
|
12 months
|
Contrast-sensitivity (Weber contrast units)
Time Frame: 12 months
|
This will be measured using the Freiburg Visual Acuity and Contrast Test (FrACT)
|
12 months
|
Forward light scatter
Time Frame: 12 months
|
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.
|
12 months
|
Higher-order aberrations (HOA) (µm)
Time Frame: 12 months
|
Measurements will be performed using Pentacam, Oculus.
HOA will be quantified as the root mean square (RMS).
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Epiretinal membrane (ERM) formation
Time Frame: 12 months
|
Formation and changes will be assessed using OCT-scans.
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUH_øjensygdomme_DSAEK_vs_DMEK
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fuchs' Endothelial Dystrophy
-
Legacy Health SystemDevers Eye Institute; Lions Eye Bank of Oregon Vision Research Laboratory; Fischer...UnknownFuchs' Corneal Endothelial DystrophyUnited States
-
Kowa Research Institute, Inc.CompletedFuchs' Endothelial Corneal DystrophyUnited States, Australia, Germany, Spain, Denmark
-
Massachusetts Eye and Ear InfirmaryRecruitingFuchs' Endothelial Corneal DystrophyUnited States
-
State University of New York at BuffaloActive, not recruitingFuchs DystrophyUnited States
-
EmmecellRecruitingEndothelial Dysfunction | Corneal Edema | Fuchs Dystrophy | Corneal Endothelial Dystrophy | Bullous Keratopathy | Pseudophakic Bullous Keratopathy | Corneal Endothelial Dysfunction | Fuchs Endothelial Corneal Dystrophy | Moderate Corneal Endothelial DecompensationUnited States
-
Charite University, Berlin, GermanyUnknownEndothelial Dysfunction | Bullous Keratopathy | Fuchs' Endothelial Corneal Dystrophy | Iridocorneal Endothelial Syndrome | Posterior Polymorphous DystrophyGermany
-
Cornea Research Foundation of AmericaCompletedBullous Keratopathy | Fuchs' Endothelial Corneal Dystrophy | Iridocorneal Endothelial Syndrome | Posterior Polymorphous DystrophyUnited States
-
Trefoil Therapeutics, Inc.CompletedEndothelial Dysfunction | Corneal Endothelial Dystrophy | Pseudophakic Bullous Keratopathy | Fuchs Endothelial Corneal DystrophyUnited States
-
Centre Hospitalier Universitaire de Saint EtienneKyoto University, Graduate School of MedicineCompletedFuchs Endothelial Corneal DystrophyFrance
-
Centre Hospitalier Régional Metz-ThionvilleCompletedPseudophakic Bullous Keratopathy | Fuchs' Endothelial Corneal Dystrophy | Descemet Membrane Endothelial Keratoplasty | Graft DetachmentFrance
Clinical Trials on Phaco-DSAEK
-
University of ZurichCompleted
-
Helsinki University Central HospitalRecruitingCataract | Normal Tension GlaucomaFinland
-
Cairo UniversityActive, not recruitingAngle Closure GlaucomaEgypt
-
Singapore National Eye CentreNational Medical Research Council (NMRC), Singapore; Singapore Eye Research...CompletedGlaucoma, Angle-closureSingapore
-
Democritus University of ThraceUnknown
-
Oregon Health and Science UniversityTerminated
-
Maastricht University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompleted
-
Mansoura UniversityCompletedNarrow-Angle GlaucomaEgypt
-
Centre Hospitalier Régional Metz-ThionvilleCompletedCorneal Transplant
-
Universitaire Ziekenhuizen KU LeuvenCompleted