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

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

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.

Study Overview

• Status: Completed
• Conditions: Visual Function
• Intervention / Treatment: Device: EyeMirage device

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 0S8
      • St. Boniface Eye Care Centre
    • Winnipeg, Manitoba, Canada, R2M 2X9
      • Brain, Vision and Concussion Clinic
    • Winnipeg, Manitoba, Canada, R2V 3C4
      • Prairie Eye Care (Northgate)
    • Winnipeg, Manitoba, Canada, R3G 0S7
      • Armstrong + Small Eye Care Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: EyeMirage device; This is a novel, smartphone-based device powered by artificial intelligence that will be used for virtual and remote routine eye examinations.
Other: 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.	Device: EyeMirage device; This is a novel, smartphone-based device powered by artificial intelligence that will be used for virtual and remote routine eye examinations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy and Reliability of EyeMirage Test Results from Four Elements of Visual Testing in Comparison to Current Standard of Care	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.	From enrollment to the end of follow-up visit at Day 30 + 7 days

Collaborators and Investigators

• Sponsor: Neuroptek Corporation Inc.
• Collaborators: St. Boniface Hospital; St. Boniface Hospital Asper Clinical Research Institute
• Investigators: Study Director: Bram Ramjiawan, PhD, St. Boniface Hospital Asper Clinical Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2025
• Primary Completion (Actual): February 24, 2026
• Study Completion (Actual): February 24, 2026

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: visual field; visual acuity; visual function; color vision; self-paced saccade
• Other Study ID Numbers: HS26606 (B2024:096); N001 (Other Identifier: Neuroptek Corporation Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data gathered from the use of the device as compared to standard of care in testing for visual acuity, visual field, color vision, and self-paced saccade will be shared.
• IPD Sharing Time Frame: Within a year after the final study report has been generated.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No