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

Fuchs' Endothelial Corneal Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01979250
• Other study ID #: DSAEKtrial1
• Status: Completed
• Phase: N/A
• First received: October 30, 2013
• Last updated: August 10, 2016
• Start date: October 2013
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 100 Years

Eligibility

Inclusion Criteria:

• Fuchs' endothelial dystrophy

• Candidate for DSAEK surgery

Exclusion Criteria:

• other ocular comorbidities that potentially limit vision or contrast vision

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fuchs' Endothelial Corneal Dystrophy
• Fuchs' Endothelial Dystrophy
• Iridocorneal Endothelial Syndrome

Intervention

Procedure:
• DSAEK surgery
Corneal endothelial transplantation by "Descemet's stripping automated endothelial keratoplasty" (DSAEK).

Locations

Country	Name	City	State
Denmark	Department of Ophthalmology	Aarhus	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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 Jun 7. doi: 10.1111/aos.13126. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Refractive properties, corneal clarity, subjective satisfaction	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.	Up to 3 years	No
Primary	Visual acuity		Up to 3 years	No