NCT05030714

Brief Summary

This proof-of-concept study aims to determine the feasibility and effectiveness of using a custom head-mounted device for visual field testing. The novel head-mounted device, with custom software, will be compared to a conventional visual field test: The Humphrey Visual Field Analyzer. The investigators will include 30 healthy normal patients, 30 glaucoma suspects, 30 patients with moderate glaucoma, and 30 patients with advanced glaucoma (total: 120 patients). Each patient will perform the conventional test and the head-mounted device visual field test during the study visit, with the order (i.e., which device the patient starts with) being randomized. After the two tests, the patient will fill out a questionnaire to gather information regarding patient comfort and satisfaction. This will repeat each week for 5 weeks, for a total of 5 study visits. The results of the tests (sensitivity thresholds) will be compared. The investigators hypothesize that the results of the conventional and head-mounted device will be similar.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
1.6 years until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

3 years

First QC Date

August 23, 2021

Last Update Submit

February 16, 2023

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Visual field differential light sensitivity

    Comparison of differential light sensitivity threshold estimated with the Humphrey Visual Field Analyzer and the custom head-mounted device.

    5 weeks

Secondary Outcomes (1)

  • Reproducibility of sensitivity values

    5 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

Patients will perform visual field testing with the Humphrey Visual Field Analyzer and with the custom head-mounted device.

Diagnostic Test: Visual Field Testing

Interventions

Visual Field TestingDIAGNOSTIC_TEST

Visual field testing using the protocol 24-2 and/or 10-2 Threshold Test

Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous visual field test with Humphrey Field Analyzer indicating normal field, early glaucomatous field damage, moderate glaucomatous field damage, or advanced glaucomatous field damage.
  • Ability to understand and consent to the study.

You may not qualify if:

  • Diagnosis of secondary glaucoma
  • Diagnosis of non-glaucomatous optic neuropathy or other significant ophthalmic diagnosis that could limit vision (ex. age-related macular degeneration)
  • Significant media opacity
  • Previous intraocular surgery other than cataract surgery
  • Anxiety disorder
  • Pregnancy
  • Seizure disorder
  • Cardiac pacemaker or other implantable devices
  • Severe vertigo or balance disturbance
  • Refractive error greater than +4 diopters and less than -6 diopters spherical equivalent
  • Inability to demonstrate competence to make informed decision regarding study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Victoria General Hopsital - Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Eadie Technologies Inc.

Halifax, Nova Scotia, B3L 4W8, Canada

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Visual Fields

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena

Study Officials

  • Brennan Eadie, MD, PhD

    Nova Scotia Healthy Authority

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brennan Eadie, MD, PhD

CONTACT

902-292-0873eadie.brennan.d@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, Department of Ophthalmology, Dalhousie University and Nova Scotia Health Authority; MD, PhD, FRCSC

Study Record Dates

First Submitted

August 23, 2021

First Posted

September 1, 2021

Study Start

April 1, 2023

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations

CA(2)