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Partial Least Squares Regression Modelling for Glaucoma Detection

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ClinicalTrials.gov Identifier: NCT03365245
Recruitment Status : Completed
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

November 4, 2017
December 7, 2017
December 7, 2017
August 2015
November 2016   (Final data collection date for primary outcome measure)
partial least square regression [ Time Frame: one month ]
Development of a partial least squares regression model to detect glaucoma
Same as current
No Changes Posted
  • reproducibility [ Time Frame: one month ]
    Comparison of reproducibility of microperimetry and visual field testing
  • 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
  • Microperimetry versus visual field testing [ Time Frame: one month ]
    Comparison of microperimetry and visual field testing
Same as current
Not Provided
Not Provided
 
Partial Least Squares Regression Modelling for Glaucoma Detection
Partial Least Squares Regression Modelling for Glaucoma Detection Using Retinal Nerve Fiber Layer, Ganglion Cell Layer and Visual Field Data

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.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Glaucoma
  • Device: Microperimetry
    Microperimetry is performed at three different days
  • Device: automated visual field
    Automated visual field ist performed at three different days
study arm
Microperimetry and automated visual field are performed at three different days
Interventions:
  • Device: Microperimetry
  • Device: automated visual field
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
Same as current
November 2016
November 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT03365245
PLSR
No
Not Provided
Not Provided
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
Vienna Institute for Research in Ocular Surgery
Not Provided
Principal Investigator: Oliver Findl, MD Vienna Institute for Research in Ocular Surgery
Vienna Institute for Research in Ocular Surgery
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP