Clinical trial NCT01979250: Fuchs' Endothelial Dystrophy: Clinical Characteristics, Treatment Outcome, and Pathology
Official title: Fuchs' Endothelial Dystrophy: Clinical Characteristics, Treatment Outcome, and Pathology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fuchs' Endothelial Corneal Dystrophy
Keywords: endothelial keratoplasty
Descemet's stripping automated endothelial keratoplasty
lamellar keratoplasty
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 81
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* Fuchs' endothelial dystrophy
* Candidate for DSAEK surgery

Exclusion Criteria:

* other ocular comorbidities that potentially limit vision or contrast vision

Primary outcomes:
measure: Visual acuity
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
measure: Refractive properties, corneal clarity, subjective satisfaction
timeFrame: Up to 3 years
Locations:
city: Aarhus
country: Denmark
facility: Department of Ophthalmology
state: Aarhus C
Study officials:
affiliation: Aarhus University Hospital
name: Esben Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nielsen E, Ivarsen A, Kristensen S, Hjortdal J. Fuchs' endothelial corneal dystrophy: a controlled prospective study on visual recovery after endothelial keratoplasty. Acta Ophthalmol. 2016 Dec;94(8):780-787. doi: 10.1111/aos.13126. Epub 2016 Jun 7.