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

NCT ID: NCT01979250

Last Updated: 2016-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-08-31

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

Conditions

Fuchs' Endothelial Corneal Dystrophy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal corneas

Normal corneas from patients that undergo cataract surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

DSAEK surgery

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

Group Type: OTHER

DSAEK surgery

Intervention Type: PROCEDURE

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

Interventions

DSAEK surgery

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

Intervention Type: PROCEDURE

Other Intervention Names

DSEK; Endothelial keratoplasty; Lamellar keratoplasty; Descemet's stripping automated endothelial keratoplasty

Eligibility Criteria

Inclusion Criteria

• Fuchs' endothelial dystrophy
• Candidate for DSAEK surgery

Exclusion Criteria

• other ocular comorbidities that potentially limit vision or contrast vision

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Esben Nielsen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esben Nielsen, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Department of Ophthalmology

Aarhus, Aarhus C, Denmark

Countries

Denmark

References

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.

Reference Type: RESULT

PMID: 27273977 (View on PubMed)

Study Documents

Document Type: Manuscript

To acces the results, please go to the above mentioned manuscript.

View Document

Other Identifiers

DSAEKtrial1

Identifier Type: -

Identifier Source: org_study_id