Fuchs' Endothelial Dystrophy: Clinical Characteristics, Treatment Outcome, and Pathology
Condition: Fuchs' Endothelial Corneal Dystrophy
MeSH terms: Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy
Study type: Interventional

Summary: 
      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.
    

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
    

Intervention name(s): DSAEK surgery
Intervention type(s): Procedure
Intervention description(s): Corneal endothelial transplantation by "Descemet's stripping automated endothelial keratoplasty" (DSAEK).
Other intervention name(s): DSEK; Endothelial keratoplasty; Lamellar keratoplasty; Descemet's stripping automated endothelial keratoplasty
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endothelial keratoplasty; Descemet's stripping automated endothelial keratoplasty; lamellar keratoplasty