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

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.

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Key information

Conditions

Visual Function

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Armstrong + Small Eye Care Centre, Winnipeg, Manitoba, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

Neurodegenerative diseases such as dementia-like Alzheimer's disease, posterior cortical atrophy
Movement disorders such as Parkinson's disease and Parkinsonism tremors
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.

Treatment and study plan

EyeMirage device

Device

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

Primary outcomes

Accuracy and Reliability of EyeMirage Test Results from Four Elements of Visual Testing in Comparison to Current Standard of Care

Time frame: From enrollment to the end of follow-up visit at Day 30 + 7 days

Results of the eye assessments for visual acuity, visual field, color vision, and self-paced saccade using the EyeMirage device and app, and standard of care will be analyzed using the paired t-test. Insignificant p values (>0.5) will indicate that there is no statistical difference between eye assessment results from the use of EyeMirage compared to those obtained from current standard of care clinical testing.

Sponsors and collaborators

Lead sponsor

Neuroptek Corporation Inc.

Other

Collaborators

St. Boniface Hospital
St. Boniface Hospital Asper Clinical Research Institute

Registry information

Official study title

An Open-label, Single-blinded, Randomized, 2-way Crossover, Performance Study of the EyeMirage (Test Device) Relative to Standard of Care (Reference Device) in Patients Undergoing Standard Eye Examinations for Various Conditions

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Apr 3, 2025
Registry last updated: Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed