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NCT Number: NCT01979250

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

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.

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Key information

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology

Aarhus, Aarhus C, 8000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fuchs' endothelial dystrophy
  • Candidate for DSAEK surgery

Exclusion criteria

  • other ocular comorbidities that potentially limit vision or contrast vision

Treatment and study plan

DSAEK surgery

Procedure

Corneal endothelial transplantation by "Descemet's stripping automated endothelial keratoplasty" (DSAEK).

Other names: DSEK, Endothelial keratoplasty, Lamellar keratoplasty, Descemet's stripping automated endothelial keratoplasty

Primary outcomes

  1. Visual acuity

    Time frame: Up to 3 years

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 8, 2013
Registry last updated
Aug 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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