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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Aarhus University Hospital
Sponsor:
Information provided by (Responsible Party):
Esben Nielsen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01979250
First received: October 30, 2013
Last updated: July 1, 2014
Last verified: July 2014
  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
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
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01979250

Contacts
Contact: Esben Nielsen, MD 004578463249 esbeniel@rm.dk
Contact: Jesper Hjortdal, Professor 004578463249 jesper.hjortdal@dadlnet.dk

Locations
Denmark
Department of Ophthalmology Recruiting
Aarhus, Aarhus C, Denmark, 8000
Contact: Esben Nielsen, MD    004578463249    esbeniel@rm.dk   
Principal Investigator: Esben Nielsen, MD         
Sponsors and Collaborators
Aarhus University Hospital
Investigators
Principal Investigator: Esben Nielsen, MD Aarhus University Hospital
  More Information

No publications provided

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: July 1, 2014
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:
Corneal Dystrophies, Hereditary
Fuchs' Endothelial Dystrophy
Iridocorneal Endothelial Syndrome
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Iris Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on July 22, 2014