Clinical trial NCT06908967: 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
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Visual Function
Keywords: visual function
visual acuity
visual field
color vision
self-paced saccade
Lead sponsor: Neuroptek Corporation Inc.
Sponsor class: OTHER
Collaborators: name: St. Boniface Hospital
name: St. Boniface Hospital Asper Clinical Research Institute
First posted: 2025-04-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy and Reliability of EyeMirage Test Results from Four Elements of Visual Testing in Comparison to Current Standard of Care
timeFrame: From enrollment to the end of follow-up visit at Day 30 + 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Prairie Eye Care
state: Manitoba
city: Winnipeg
country: Canada
facility: St. Boniface Eye Care Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: Brain, Vision and Concussion Clinic
state: Manitoba
city: Winnipeg
country: Canada
facility: Eyes in the Village
state: Manitoba
Study officials:
affiliation: St. Boniface Hospital Asper Clinical Research Institute
name: Bram Ramjiawan, PhD
role: STUDY_DIRECTOR
References: