Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-20 @ 2:49 PM
Study NCT ID:
NCT01979250
Status:
COMPLETED
Last Update Posted:
2016-08-11
First Post:
2013-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fuchs' Endothelial Dystrophy: Clinical Characteristics, Treatment Outcome, and Pathology
Sponsor:
Aarhus University Hospital
Organization:
Study Overview
Official Title:
Fuchs' Endothelial Dystrophy: Clinical Characteristics, Treatment Outcome, and Pathology
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: