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

Neuroptek Corporation Inc.

Status: Enrolling

Conditions: Visual Function

Treatments: Device: EyeMirage device

Study type: Interventional

Funder types: Other

Identifiers

NCT06908967

HS26606 (B2024:096)

N001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Standard of Care

Other group

Description:

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.

Treatment:

Device: EyeMirage device

EyeMirage

Other group

Description:

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.

Treatment:

Device: EyeMirage device