Fuchs' Endothelial Dystrophy: Clinical Characteristics, Treatment Outcome, and Pathology

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Esben Nielsen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
First received: October 30, 2013
Last updated: January 13, 2015
Last verified: January 2015

Background Fuchs' Endothelial Dystrophy Fuchs' Endothelial Dystrophy (Fuchs' ED) is characterized by changes on the inside of the cornea, which leads to a substantial decline in visual acuity. The only effective treatment option for Fuchs' ED is corneal transplantation.

Corneal transplantation Corneal transplantation surgery has seen major advances in the last decade, and the Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) procedure has now become the preferred method.

Outcome There have been a substantial number of publications on outcome after DSAEK surgery, and the procedure has several advantages over the former preferred method of transplantation, penetrating keratoplasty (PK).

Despite the apparent success of the DSAEK procedure, visual acuity is seldom fully restored even in otherwise healthy eyes. Several studies have tried to clarify this matter but so far results have been conflicting.


  1. The reduction in visual acuity and contrast sensitivity in patients with Fuchs' endothelial dystrophy is correlated with corneal thickness, corneal light scatter, and the type and magnitude of optical disrupting guttae in Descemet's membrane.
  2. The subjective visual function after corneal transplantation with a posterior lamellar graft is correlated with the optical properties of the grafted cornea (thickness, light scatter, irregularities on the anterior, and posterior corneal surfaces)

Materials and methods

In a controlled prospective trial of DSAEK patients, we aim to register different morphological patterns, monitor visual performance and optical parameters.

Three sex and age-matched groups will be compared:

Group 1: 40 patients that undergo DSAEK surgery Group 2: 40 patients that undergo combined cataract and DSAEK surgery. Group 3: Control group of 40 patients with normal corneas that undergo cataract surgery.

Condition Intervention
Fuchs' Endothelial Corneal Dystrophy
Procedure: DSAEK surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fuchs' Endothelial Dystrophy: Clinical Characteristics, Treatment Outcome, and Pathology

Resource links provided by NLM:

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Refractive properties, corneal clarity, subjective satisfaction [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Subjective satisfaction will be measured using the Catquest 9SF questionnaire which uses a Likert scale which in turn is converted into a Rasch scale. The scales is linear, and uses a unit called the logit.

Estimated Enrollment: 80
Study Start Date: October 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Normal corneas
Normal corneas from patients that undergo cataract surgery.
DSAEK surgery
Corneal endothelial transplantation by Descemet's stripping automated endothelial keratoplasty (DSAEK).
Procedure: DSAEK surgery
Corneal endothelial transplantation by "Descemet's stripping automated endothelial keratoplasty" (DSAEK).
Other Names:
  • DSEK
  • Endothelial keratoplasty
  • Lamellar keratoplasty
  • Descemet's stripping automated endothelial keratoplasty

Detailed Description:

Investigation outline:

  • Presence of the following patterns will be registered for each patient: Scattered guttae, confluent guttae, diffuse corneal oedema or confined corneal oedema
  • Refractive properties: Objective and subjective refraction
  • Visual performance: Visual acuity (ETDRS), Contrast sensitivity (FrACT method)
  • Corneal characterization: corneal sensibility (Cochet-Bonnet), In vivo confocal microscopy, specular microscopy, anterior segment OCT, OLCR, Pentacam with densitometry, and slit-lamp investigation will be performed.
  • Catquest 9SF questionnaire

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Fuchs' endothelial dystrophy
  • Candidate for DSAEK surgery

Exclusion Criteria:

  • other ocular comorbidities that potentially limit vision or contrast vision
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01979250

Department of Ophthalmology
Aarhus, Aarhus C, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
Principal Investigator: Esben Nielsen, MD Aarhus University Hospital
  More Information

Responsible Party: Esben Nielsen, MD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01979250     History of Changes
Other Study ID Numbers: DSAEKtrial1 
Study First Received: October 30, 2013
Last Updated: January 13, 2015
Health Authority: Denmark: Danish Health and Medicines Authority

Keywords provided by Aarhus University Hospital:
endothelial keratoplasty
Descemet's stripping automated endothelial keratoplasty
lamellar keratoplasty

Additional relevant MeSH terms:
Fuchs' Endothelial Dystrophy
Iridocorneal Endothelial Syndrome
Corneal Diseases
Corneal Dystrophies, Hereditary
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Iris Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on May 26, 2016