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

Primary Purpose

Fuchs' Endothelial Corneal Dystrophy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
DSAEK surgery
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fuchs' Endothelial Corneal Dystrophy focused on measuring endothelial keratoplasty, Descemet's stripping automated endothelial keratoplasty, lamellar keratoplasty

Eligibility Criteria

40 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fuchs' endothelial dystrophy
  • Candidate for DSAEK surgery

Exclusion Criteria:

  • other ocular comorbidities that potentially limit vision or contrast vision

Sites / Locations

  • Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Normal corneas

DSAEK surgery

Arm Description

Normal corneas from patients that undergo cataract surgery.

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

Outcomes

Primary Outcome Measures

Visual acuity

Secondary Outcome Measures

Full Information

First Posted
October 30, 2013
Last Updated
August 10, 2016
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01979250
Brief Title
Fuchs' Endothelial Dystrophy: Clinical Characteristics, Treatment Outcome, and Pathology
Official Title
Fuchs' Endothelial Dystrophy: Clinical Characteristics, Treatment Outcome, and Pathology
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Endothelial Corneal Dystrophy
Keywords
endothelial keratoplasty, Descemet's stripping automated endothelial keratoplasty, lamellar keratoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal corneas
Arm Type
No Intervention
Arm Description
Normal corneas from patients that undergo cataract surgery.
Arm Title
DSAEK surgery
Arm Type
Other
Arm Description
Corneal endothelial transplantation by Descemet's stripping automated endothelial keratoplasty (DSAEK).
Intervention Type
Procedure
Intervention Name(s)
DSAEK surgery
Other Intervention Name(s)
DSEK, Endothelial keratoplasty, Lamellar keratoplasty, Descemet's stripping automated endothelial keratoplasty
Intervention Description
Corneal endothelial transplantation by "Descemet's stripping automated endothelial keratoplasty" (DSAEK).
Primary Outcome Measure Information:
Title
Visual acuity
Time Frame
Up to 3 years
Other Pre-specified Outcome Measures:
Title
Refractive properties, corneal clarity, subjective satisfaction
Description
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.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fuchs' endothelial dystrophy Candidate for DSAEK surgery Exclusion Criteria: other ocular comorbidities that potentially limit vision or contrast vision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esben Nielsen, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology
City
Aarhus
State/Province
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
27273977
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.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Manuscript
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/27273977
Available IPD/Information Comments
To acces the results, please go to the above mentioned manuscript.

Learn more about this trial

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

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