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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01979250
First Posted: November 8, 2013
Last Update Posted: August 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Esben Nielsen, Aarhus University Hospital
  Purpose

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.

Hypotheses

  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
Intervention Model: Parallel Assignment
Masking: None (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 Esben Nielsen, Aarhus University Hospital:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: Up to 3 years ]

Other Outcome Measures:
  • Refractive properties, corneal clarity, subjective satisfaction [ Time Frame: Up to 3 years ]
    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.


Enrollment: 81
Study Start Date: October 2013
Study Completion Date: August 2016
Primary Completion Date: August 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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fuchs' endothelial dystrophy
  • Candidate for DSAEK surgery

Exclusion Criteria:

  • other ocular comorbidities that potentially limit vision or contrast vision
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01979250


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

Publications:
Study Data/Documents: Manuscript  This link exits the ClinicalTrials.gov site
To acces the results, please go to the above mentioned manuscript.

Responsible Party: Esben Nielsen, MD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01979250     History of Changes
Other Study ID Numbers: DSAEKtrial1
First Submitted: October 30, 2013
First Posted: November 8, 2013
Last Update Posted: August 11, 2016
Last Verified: August 2016

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

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