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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06908967

Enrollment

160

Registered

2025-04-03

Start date

2025-06-13

Completion date

2026-02-24

Last updated

2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Function

Keywords

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

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.

Interventions

DEVICEEyeMirage device

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SCREENING

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Accuracy and Reliability of EyeMirage Test Results from Four Elements of Visual Testing in Comparison to Current Standard of Care	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.

Countries

Canada

Contacts

STUDY_DIRECTORBram Ramjiawan, PhD

St. Boniface Hospital Asper Clinical Research Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026