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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):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Glaucoma Device: Microperimetry Device: automated visual field

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Partial Least Squares Regression Modelling for Glaucoma Detection Using Retinal Nerve Fiber Layer, Ganglion Cell Layer and Visual Field Data
Study Start Date : August 2015
Primary Completion Date : November 2016
Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
study arm
Microperimetry and automated visual field are performed at three different days
Device: Microperimetry
Microperimetry is performed at three different days
Device: automated visual field
Automated visual field ist performed at three different days


Outcome Measures

Primary Outcome Measures :
  1. partial least square regression [ Time Frame: one month ]
    Development of a partial least squares regression model to detect glaucoma


Secondary Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365245


Locations
Austria
VIROS
Vienna, Austria, 1140
Sponsors and Collaborators
Vienna Institute for Research in Ocular Surgery
Investigators
Principal Investigator: Oliver Findl, MD Vienna Institute for Research in Ocular Surgery
More Information

Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT03365245     History of Changes
Other Study ID Numbers: PLSR
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases