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

NCT06908967 | Completed

• 2 other identifiers: HS26606 (B2024:096)N001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Visual Function

Keywords

visual function; visual acuity; visual field; color vision; self-paced saccade

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard of Care

OTHER

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

EyeMirage

OTHER

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

Interventions

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.

EyeMirage; Standard of Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Boniface Hospital: collaborator
• St. Boniface Hospital Asper Clinical Research Institute: collaborator
• Neuroptek Corporation Inc.: lead

Study Sites (4)

St. Boniface Eye Care Centre

Winnipeg, Manitoba, R2H 0S8, Canada

Location

Brain, Vision and Concussion Clinic

Winnipeg, Manitoba, R2M 2X9, Canada

Location

Prairie Eye Care (Northgate)

Winnipeg, Manitoba, R2V 3C4, Canada

Location

Armstrong + Small Eye Care Centre

Winnipeg, Manitoba, R3G 0S7, Canada

Location

Study Officials

• Bram Ramjiawan, PhD

  St. Boniface Hospital Asper Clinical Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 3, 2025
• Study Start: June 13, 2025
• Primary Completion: February 24, 2026
• Study Completion: February 24, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Within a year after the final study report has been generated.

Locations

CA (4)