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OpenTrials
Completed

NCT Number: NCT03365245

Partial Least Squares Regression Modelling for Glaucoma Detection

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VIROS

Vienna, 1140, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Microperimetry

Device

Microperimetry is performed at three different days

automated visual field

Device

Automated visual field ist performed at three different days

Primary outcomes

  1. partial least square regression

    Time frame: one month

    Development of a partial least squares regression model to detect glaucoma

Secondary outcomes

  1. reproducibility

    Time frame: one month

    Comparison of reproducibility of microperimetry and visual field testing

  2. Retinal nerve fiber thickness (RNFL) and the the retinal ganglion cell layer (RGCL)

    Time frame: one month

    The retinal nerve fiber layer thickness and the thickness of the retinal ganglion cell layer will be compared

  3. Microperimetry versus visual field testing

    Time frame: one month

    Comparison of microperimetry and visual field testing

Sponsors and collaborators

Lead sponsor

Vienna Institute for Research in Ocular Surgery

Other

Registry information

Official study title

Partial Least Squares Regression Modelling for Glaucoma Detection Using Retinal Nerve Fiber Layer, Ganglion Cell Layer and Visual Field Data

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 7, 2017
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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