Fuchs' Endothelial Dystrophy: Clinical Characteristics, Treatment Outcome, and Pathology
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|ClinicalTrials.gov Identifier: NCT01979250|
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : August 11, 2016
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.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Fuchs' Endothelial Corneal Dystrophy||Procedure: DSAEK surgery||Not Applicable|
- 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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fuchs' Endothelial Dystrophy: Clinical Characteristics, Treatment Outcome, and Pathology|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
No Intervention: Normal corneas
Normal corneas from patients that undergo cataract surgery.
Corneal endothelial transplantation by Descemet's stripping automated endothelial keratoplasty (DSAEK).
Procedure: DSAEK surgery
Corneal endothelial transplantation by "Descemet's stripping automated endothelial keratoplasty" (DSAEK).
- Visual acuity [ Time Frame: Up to 3 years ]
- Refractive properties, corneal clarity, subjective satisfaction [ Time Frame: Up to 3 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01979250
|Department of Ophthalmology|
|Aarhus, Aarhus C, Denmark, 8000|
|Principal Investigator:||Esben Nielsen, MD||Aarhus University Hospital|