EyeMirage Device for Visual Function

Recruiting at 3 trial locations

Overseen By Bram Ramjiawan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neuroptek Corporation Inc.

Disqualifiers: Blindness, Alzheimer's, Parkinson's, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

160 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the EyeMirage treatment?

The OrCam MyEye device, a similar assistive technology for visually impaired individuals, showed improvements in daily tasks like reading and face recognition, suggesting that devices like EyeMirage could also enhance visual function. ^{1 2 3 4 5}

What safety data exists for the EyeMirage device or similar visual prosthetic devices?

The Argus II Retinal Prosthesis System, a similar visual prosthetic device, has been implanted in over 100 patients and demonstrated a robust safety profile in a clinical trial with 30 patients. This suggests that such devices are generally safe for human use. ^{4 6 7 8 9}

How does the EyeMirage treatment differ from other treatments for visual function?

The EyeMirage treatment is unique because it uses a compact, low-cost microelectromechanical mirror for adaptive optics, which can improve vision by correcting the eye's optics and enhancing retinal images. This approach is more affordable and physically smaller than traditional adaptive optics systems, making it more accessible for widespread use. ^{2 3 10 11 12}

Research Team

Bram Ramjiawan, PhD

Principal Investigator

St. Boniface Hospital Asper Clinical Research Institute

Eligibility Criteria

This clinical trial is for individuals aged 18 to 65 who are undergoing standard eye examinations. Participants will be assessed using both the EyeMirage device and standard devices during a single clinic visit, with a follow-up call after thirty days.

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

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

Eyes with a spherical equivalent of greater than +9 or -9 diopters where the corrective lens is too large to fit in the headset

I am completely blind or have severe vision loss in one eye.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo four eye tests using both the new EyeMirage device and the standard of care devices

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any issues and discuss results 30 days after the eye tests

4 weeks

1 call (virtual)

Treatment Details

Interventions

• EyeMirage

Trial Overview The trial is testing the EyeMirage device's effectiveness by comparing it against standard eye examination tools. It measures visual acuity, visual field, color vision, and saccade timing in patients with various conditions.

Participant Groups

Group I: Standard of Care Experimental Treatment 1 Intervention

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.

Group II: EyeMirage Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Neuroptek Corporation Inc.

Lead Sponsor

St. Boniface Hospital

Collaborator

Trials

55

Recruited

15,000+

St. Boniface Hospital Asper Clinical Research Institute

Collaborator

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Rehabilitation methods for individuals with functional vision disorders]. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

[A reading aid for the visually handicapped]. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

A new mirror design for hemianopia. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Patients' Satisfaction with the ORCAM MyEye Device Among Visually Impaired People: A Multicenter Study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Users' subjective evaluation of electronic vision enhancement systems. [2019]

6. England pubmed.ncbi.nlm.nih.gov

The Argus(®) II Retinal Prosthesis System. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Implantable miniature telescope for the treatment of visual acuity loss resulting from end-stage age-related macular degeneration: 1-year results. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Are wearable electronic vision enhancement systems (wEVES) beneficial for people with age-related macular degeneration? A scoping review. [2023]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Improving quality of life in patients with end-stage age-related macular degeneration: focus on miniature ocular implants. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Use of a microelectromechanical mirror for adaptive optics in the human eye. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Dynamic photorefraction system: an offline application for the dynamic analysis of ocular focus and pupil size from photorefraction images. [2009]

12. United States pubmed.ncbi.nlm.nih.gov

Compact, modular and in-plane AOSLO for high-resolution retinal imaging. [2020]