NCT01979250

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. 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. 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

2.8 years

First QC Date

October 30, 2013

Last Update Submit

August 10, 2016

Conditions

Fuchs' Endothelial Corneal Dystrophy

Keywords

endothelial keratoplastyDescemet's stripping automated endothelial keratoplastylamellar keratoplasty

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Up to 3 years

Other Outcomes (1)

  • Refractive properties, corneal clarity, subjective satisfaction

    Up to 3 years

Study Arms (2)

Normal corneas

NO INTERVENTION

Normal corneas from patients that undergo cataract surgery.

DSAEK surgery

OTHER

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

Procedure: DSAEK surgery

Interventions

DSAEK surgeryPROCEDURE

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

Also known as: DSEK, Endothelial keratoplasty, Lamellar keratoplasty, Descemet's stripping automated endothelial keratoplasty
DSAEK surgery

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fuchs' endothelial dystrophy
  • Candidate for DSAEK surgery

You may not qualify if:

  • other ocular comorbidities that potentially limit vision or contrast vision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology

Aarhus, Aarhus C, 8000, Denmark

Location

Related 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 Dec;94(8):780-787. doi: 10.1111/aos.13126. Epub 2016 Jun 7.

    PMID: 27273977RESULT

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Interventions

Descemet Stripping Endothelial KeratoplastyCorneal Transplantation

Condition Hierarchy (Ancestors)

Corneal Dystrophies, HereditaryCorneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeTransplantation

Study Officials

  • Esben Nielsen, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 8, 2013

Study Start

October 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 11, 2016

Record last verified: 2016-08

Locations

DK(1)