Reproducibility of RNFL Circle Scans With ART-Function of Heidelberg Spectralis SD-OCT Software Version 5.3

NCT ID: NCT01299233

Last Updated: 2015-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2015-12-31

Brief Summary

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To assess the improvement in reproducibility of 100 vs. 16 averaged images by Automatic Real Time (ART) using Spectralis™ Spectral Domain-Optical Coherence Tomography (SD-OCT, Heidelberg Engineering GmbH, Heidelberg, Germany) in retinal nerve fiber layer thickness (RNFL) circle scan-measurements.

* Trial with medical device

Detailed Description

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Conditions

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Glaucoma Patients and Healthy Controls

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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control group

age matched healthy controls

Spectralis® SD-OCT, Heidelberg Engineering GmbH, H

Intervention Type DEVICE

Measurement of the peripapillar nerve fiber layer with different settings of ART

Glaucoma

patients with diagnosis of primary open angle glaucoma

Spectralis® SD-OCT, Heidelberg Engineering GmbH, H

Intervention Type DEVICE

Measurement of the peripapillar nerve fiber layer with different settings of ART

Interventions

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Spectralis® SD-OCT, Heidelberg Engineering GmbH, H

Measurement of the peripapillar nerve fiber layer with different settings of ART

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

for both groups (glaucoma study group and control group): men and women of at least 50 years of age

for the glaucoma study group: diagnosis of primary open angle glaucoma (POAG)

Exclusion Criteria

for both groups (glaucoma study group and control group):

* less then 18 years of age
* any pathology of the central retina
* any optic nerve disorder other then glaucoma
* retinal vascular disorder

for the glaucoma study group: other glaucoma diagnosis then primary open angle glaucoma

for the control group: any diagnosis of glaucoma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Funk, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Ophtalmic Clinic

Locations

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University Hospital Zurich, Ophthalmic Clinic

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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ART-OCT

Identifier Type: -

Identifier Source: org_study_id

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