Partial Least Squares Regression Modelling for Glaucoma Detection

NCT ID: NCT03365245

Last Updated: 2017-12-07

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

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-11-30

Brief Summary

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A partial least squares regression model for visual field testing among glaucoma patients will be developed.

In addition, microperimetry will be compared to conventional perimetry and reproducibility will be assessed.

Detailed Description

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Aim of this study is to develop a partial least squares regression model incorporating retinal nerve fiber layer (RNFL) and retinal ganglion cell layer (RGCL) measurements as well as visual field testing to represent a glaucoma expert opinion on the stage of glaucoma.

In addition, microperimetry will be compared to conventional perimetry and reproducibility will be assessed.

Conditions

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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study arm

Microperimetry and automated visual field are performed at three different days

Group Type OTHER

Microperimetry

Intervention Type DEVICE

Microperimetry is performed at three different days

automated visual field

Intervention Type DEVICE

Automated visual field ist performed at three different days

Interventions

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Microperimetry

Microperimetry is performed at three different days

Intervention Type DEVICE

automated visual field

Automated visual field ist performed at three different days

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 21 and older
* written informed consent prior to surgery
* any glaucoma-associated changes in one or both eyes (i.e. increased intraocular pressure, optic disc changes, known visual field defects) in the "glaucoma patients" and the absence of any glaucoma associated changes in the "healthy eyes group".

Exclusion Criteria

* Secondary glaucoma
* In case of pregnancy (pregnancy test will be taken in women of reproductive age)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role lead

Responsible Party

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Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oliver Findl, MD

Role: PRINCIPAL_INVESTIGATOR

Vienna Institute for Research in Ocular Surgery

Locations

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VIROS

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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PLSR

Identifier Type: -

Identifier Source: org_study_id