Partial Least Squares Regression Modelling for Glaucoma D... | NCT03365245

Studies
Partial Least Squares Regression Modelling for Glaucoma Detection

NCT03365245

Sponsor

Vienna Institute for Research in Ocular Surgery

Status

Completed

Last Update Posted

Dec 7, 2017Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Glaucoma

Interventions

Microperimetry
automated visual field

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Nov 2016Actual

Completion Date

Nov 2016Actual

First Submitted Date

Nov 4, 2017

First Submission Date that Met QC Criteria

Dec 1, 2017

First Posted Date

Dec 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2017

Last Update Posted Date

Dec 7, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular SurgeryPrincipal Investigator

Lead Sponsor

Vienna Institute for Research in Ocular SurgeryOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study arm	Other	Microperimetry and automated visual field are performed at three different days	Device: Microperimetry Device: automated visual field

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Microperimetry	Device	Microperimetry is performed at three different days	study arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oliver Findl, MD	Vienna Institute for Research in Ocular Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VIROS		Vienna		1140	Austria

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D058609	Visual Field Tests

Ancestor Terms

ID	Term
D014787	Vision Tests
D003941	Diagnostic Techniques, Ophthalmological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided