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

Aarhus University Hospital

Status: Completed

Conditions: Fuchs' Endothelial Corneal Dystrophy

Treatments: Procedure: DSAEK surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01979250

DSAEKtrial1

Details and patient eligibility

About

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.

Full 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

Enrollment: 81 patients

Sex: All

Ages: 40 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fuchs' endothelial dystrophy
• Candidate for DSAEK surgery

Exclusion criteria

• other ocular comorbidities that potentially limit vision or contrast vision

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

Normal corneas

No Intervention group

Description:

Normal corneas from patients that undergo cataract surgery.

DSAEK surgery

Other group

Description:

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

Treatment:

Procedure: DSAEK surgery