Evaluation of a Novel Head-Mounted Device for Glaucoma Testing: A Proof-of-Concept Study
Primary Purpose
Glaucoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Visual Field Testing
Sponsored by
About this trial
This is an interventional other trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Victoria General Hopsital - Nova Scotia Health Authority
- Eadie Technologies Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Patients will perform visual field testing with the Humphrey Visual Field Analyzer and with the custom head-mounted device.
Outcomes
Primary Outcome Measures
Visual field differential light sensitivity
Comparison of differential light sensitivity threshold estimated with the Humphrey Visual Field Analyzer and the custom head-mounted device.
Secondary Outcome Measures
Reproducibility of sensitivity values
Comparison of the reproducibility of sensitivity values estimated with the Humphrey Visual Field Analyzer and the custom head-mounted device.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05030714
Brief Title
Evaluation of a Novel Head-Mounted Device for Glaucoma Testing: A Proof-of-Concept Study
Official Title
Evaluation of a Novel Head-Mounted Device for Glaucoma Testing: A Proof-of-Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
April 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brennan Eadie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Patients will perform visual field testing with the Humphrey Visual Field Analyzer and with the custom head-mounted device.
Intervention Type
Diagnostic Test
Intervention Name(s)
Visual Field Testing
Intervention Description
Visual field testing using the protocol 24-2 and/or 10-2 Threshold Test
Primary Outcome Measure Information:
Title
Visual field differential light sensitivity
Description
Comparison of differential light sensitivity threshold estimated with the Humphrey Visual Field Analyzer and the custom head-mounted device.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Reproducibility of sensitivity values
Description
Comparison of the reproducibility of sensitivity values estimated with the Humphrey Visual Field Analyzer and the custom head-mounted device.
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brennan Eadie, MD, PhD
Phone
902-292-0873
Email
eadie.brennan.d@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brennan Eadie, MD, PhD
Organizational Affiliation
Nova Scotia Healthy Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victoria General Hopsital - Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brennan Eadie, MD, PhD
Phone
902-292-0873
Email
eadie.brennan.d@gmail.com
Facility Name
Eadie Technologies Inc.
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3L 4W8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brennan Eadie, MD, PhD
Phone
902-292-0873
Email
eadie.brennan.d@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Novel Head-Mounted Device for Glaucoma Testing: A Proof-of-Concept Study
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