A Performance Study Comparing the EyeMirage (Test Device) to Standard of Care (Reference Device) in Patients 18 to 65 Years of Age Undergoing Standard Eye Examinations Such as Visual Acuity, Visual Field, Color Vision, and Self-Paced Saccade for Various Conditions

NCT ID: NCT06908967

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-13

Study Completion Date

2025-10-31

Brief Summary

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This study will assess the effectiveness and accuracy of results of a new device for eye function testing. This will be done by comparing results of four eye tests that are done through the current standard used in eye clinics and that of this new device. Participants of this study will undergo the four eye tests using both the new device and the standard of care devices.

The study will be done in one visit to the eye clinic. Thirty days after the eye tests were done, participants will be called by the clinic for a general follow-up and to discuss any problems, if needed.

Detailed Description

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Conditions

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Visual Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators

Study Groups

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Standard of Care

This Cohort will undergo assessments for visual acuity, visual field, color vision, and self-paced saccade first via the current standard of care tests and then using the EyeMirage device and app.

Group Type OTHER

EyeMirage device

Intervention Type DEVICE

This is a novel, smartphone-based device powered by artificial intelligence that will be used for virtual and remote routine eye examinations.

EyeMirage

This Cohort will undergo assessments for visual acuity, visual field, color vision, and self-paced saccade first via the EyeMirage device and app, then via the standard of care tests.

Group Type OTHER

EyeMirage device

Intervention Type DEVICE

This is a novel, smartphone-based device powered by artificial intelligence that will be used for virtual and remote routine eye examinations.

Interventions

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EyeMirage device

This is a novel, smartphone-based device powered by artificial intelligence that will be used for virtual and remote routine eye examinations.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Evidence of a signed and dated informed consent document confirming that the participant has been informed of all aspects of the clinical study.
* Male or female participants, 18 to 65 years of age at time of screening.
* Visual acuity of 20/200 or better.
* Willingness to comply with required screening procedures, eye assessments, and follow-up visits, if needed.

Exclusion Criteria

* Visual acuity worse than 20/200 in either eye
* Complete blindness or diffuse vision loss in either eye
* Clinical diagnosis of cognitive and motor diseases including but not limited to the following:

1. Neurodegenerative diseases such as dementia-like Alzheimer's disease, posterior cortical atrophy
2. Movement disorders such as Parkinson's disease and Parkinsonism tremors
3. Multiple sclerosis, stroke or any other neurological or physical conditions with paresis or plegia (i.e. weakness or paralysis of the limbs)
* Eyes with a spherical equivalent of greater than +9 or -9 diopters where the corrective lens is too large to fit in the headset.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Boniface Hospital

OTHER

Sponsor Role collaborator

St. Boniface Hospital Asper Clinical Research Institute

UNKNOWN

Sponsor Role collaborator

Neuroptek Corporation Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bram Ramjiawan, PhD

Role: STUDY_DIRECTOR

St. Boniface Hospital Asper Clinical Research Institute

Locations

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St. Boniface Eye Care Centre

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Brain, Vision and Concussion Clinic

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Prairie Eye Care (Northgate)

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Armstrong + Small Eye Care Centre

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Bram Ramjiawan, PhD

Role: CONTACT

204-235-3206

Rhea Lopez, BS

Role: CONTACT

204-235-3206

Facility Contacts

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Melissa Kenneth, OD

Role: primary

204-504-9560

Dawn Dunford, OD

Role: primary

204-202-3932

Nana Owusu, OD

Role: primary

204-293-6884

Luke Small, OD

Role: primary

204-786-8991

Other Identifiers

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N001

Identifier Type: OTHER

Identifier Source: secondary_id

HS26606 (B2024:096)

Identifier Type: -

Identifier Source: org_study_id

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