NCT03365245

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 4, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

1.3 years

First QC Date

November 4, 2017

Last Update Submit

December 1, 2017

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • partial least square regression

    Development of a partial least squares regression model to detect glaucoma

    one month

Secondary Outcomes (3)

  • reproducibility

    one month

  • Retinal nerve fiber thickness (RNFL) and the the retinal ganglion cell layer (RGCL)

    one month

  • Microperimetry versus visual field testing

    one month

Study Arms (1)

study arm

OTHER

Microperimetry and automated visual field are performed at three different days

Device: MicroperimetryDevice: automated visual field

Interventions

MicroperimetryDEVICE

Microperimetry is performed at three different days

study arm
automated visual fieldDEVICE

Automated visual field ist performed at three different days

study arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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".

You may not qualify if:

  • Secondary glaucoma
  • In case of pregnancy (pregnancy test will be taken in women of reproductive age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VIROS

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Visual Field Tests

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Vision TestsDiagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Oliver Findl, MD

    Vienna Institute for Research in Ocular Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 4, 2017

First Posted

December 7, 2017

Study Start

August 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 7, 2017

Record last verified: 2017-12

Locations

AU(1)