A Comparison of Visual Functions and Side-effects After DSAEK or DMEK for Fuchs' Endothelial Dystrophy

NCT04417959 | Completed

• 1 other identifier: AUH_øjensygdomme_DSAEK_vs_DMEK
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fuchs' Endothelial Dystrophy

Outcome Measures

Primary Outcomes (1)

• Best corrected visual acuity (BCVA)

  BCVA will be measured using the early treatment diabetic retinopathy study (ETDRS) chart.

  12 months

Secondary Outcomes (7)

• Cystoid macular edema

  3 months

• Largest pupil diameter (mm)

  12 months

• Iris contraction velocity (mm/s)

  12 months

• Circumpapillary Retinal Nerve Fibre Layer Thickness (cpRNFLT) (µm)

  12 months

• Contrast-sensitivity (Weber contrast units)

  12 months

Other Outcomes (1)

• Epiretinal membrane (ERM) formation

  12 months

Study Arms (2)

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.

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.

Procedure: Phaco-DMEK

Interventions

Phaco-DSAEK PROCEDURE

The intervention will be performed as a DSAEK triple-procedure with phacoemulsification and intraocular lens implantation prior to DSAEK.

Phaco-DSAEK

Phaco-DMEK PROCEDURE

The intervention will be performed as a DMEK triple-procedure with phacoemulsification and intraocular lens implantation prior to DMEK.

Phaco-DMEK

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cataract and/or
• Fuch's endothelial dystrophy

You may not qualify if:

• Uveitis
• Diabetes mellitus
• Retinal vein occlusion
• Glaucoma
• Exudative age-related macular degeneration
• Advanced macular atrophy
• Ocular trauma
• Prior corneal grafting

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Ophthalmology

Aarhus, Central Jutland, 8200, Denmark

Location

Related Publications (3)

• 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. 2025 Dec 11:bjo-2025-328970. doi: 10.1136/bjo-2025-328970. Online ahead of print.

  PMID: 41381122 DERIVED

• Madsen 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.

  PMID: 37290822 DERIVED

• Molbech 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.

  PMID: 36853598 DERIVED

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects randomized to either phaco-DSAEK or phaco-DMEK will be blinded in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 5, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: September 1, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

DK (1)