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Partial Least Squares Regression Modelling for Glaucoma Detection

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Microperimetry
automated visual field
Sponsored by
Vienna Institute for Research in Ocular Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • VIROS

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

study arm

Arm Description

Microperimetry and automated visual field are performed at three different days

Outcomes

Primary Outcome Measures

partial least square regression
Development of a partial least squares regression model to detect glaucoma

Secondary Outcome Measures

reproducibility
Comparison of reproducibility of microperimetry and visual field testing
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
Microperimetry versus visual field testing
Comparison of microperimetry and visual field testing

Full Information

First Posted
November 4, 2017
Last Updated
December 1, 2017
Sponsor
Vienna Institute for Research in Ocular Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT03365245
Brief Title
Partial Least Squares Regression Modelling for Glaucoma Detection
Official Title
Partial Least Squares Regression Modelling for Glaucoma Detection Using Retinal Nerve Fiber Layer, Ganglion Cell Layer and Visual Field Data
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study arm
Arm Type
Other
Arm Description
Microperimetry and automated visual field are performed at three different days
Intervention Type
Device
Intervention Name(s)
Microperimetry
Intervention Description
Microperimetry is performed at three different days
Intervention Type
Device
Intervention Name(s)
automated visual field
Intervention Description
Automated visual field ist performed at three different days
Primary Outcome Measure Information:
Title
partial least square regression
Description
Development of a partial least squares regression model to detect glaucoma
Time Frame
one month
Secondary Outcome Measure Information:
Title
reproducibility
Description
Comparison of reproducibility of microperimetry and visual field testing
Time Frame
one month
Title
Retinal nerve fiber thickness (RNFL) and the the retinal ganglion cell layer (RGCL)
Description
The retinal nerve fiber layer thickness and the thickness of the retinal ganglion cell layer will be compared
Time Frame
one month
Title
Microperimetry versus visual field testing
Description
Comparison of microperimetry and visual field testing
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD
Organizational Affiliation
Vienna Institute for Research in Ocular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
VIROS
City
Vienna
ZIP/Postal Code
1140
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

Partial Least Squares Regression Modelling for Glaucoma Detection

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