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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1140
    • VIROS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
partial least square regression	Development of a partial least squares regression model to detect glaucoma	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reproducibility	Comparison of reproducibility of microperimetry and visual field testing	one month
Retinal nerve fiber thickness (RNFL) and the the retinal ganglion cell layer (RGCL)	The retinal nerve fiber layer thickness and the thickness of the retinal ganglion cell layer will be compared	one month
Microperimetry versus visual field testing	Comparison of microperimetry and visual field testing	one month

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: November 4, 2017
• First Submitted That Met QC Criteria: December 1, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Actual): December 7, 2017
• Last Update Submitted That Met QC Criteria: December 1, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: PLSR