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

Not Applicable

Recruiting

• Conditions: Visual Function

• Registration Number: NCT06908967
• Lead Sponsor: Neuroptek Corporation Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-26
• Study First Posted: 2025-04-03
• Study Start: 2025-06-13
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-12
• Last Update Posted: 2025-08-15
• Primary Completion: 2025-10
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Prairie Eye Care (Northgate); 🇨🇦 Winnipeg, Manitoba, Canada

Armstrong + Small Eye Care Centre; 🇨🇦 Winnipeg, Manitoba, Canada

St. Boniface Eye Care Centre; 🇨🇦 Winnipeg, Manitoba, Canada

Brain, Vision and Concussion Clinic; 🇨🇦 Winnipeg, Manitoba, Canada