PAVE System for Visual Field Loss

Overseen By Paige Clinical Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NeuroAEye LLC

Must not be taking: Amphetamines, Dopamine

Disqualifiers: Photosensitive epilepsy, Immune disorders, others

Compensation: Varies

Number of Visits: 1

Duration: 8-24 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the PAVE System, which uses virtual reality to improve vision problems caused by stroke, brain injury, or brain surgery. The goal is to determine if this therapy can expand the visual field (the area a person can see) more effectively than a placebo. Participants will attend weekly therapy sessions, with regular checks on their vision progress. Ideal candidates for this trial are individuals experiencing long-term vision loss due to these brain conditions, diagnosed at least 6 months ago. As an unphased trial, this study offers a unique opportunity to explore innovative therapy for vision improvement.

Will I have to stop taking my current medications?

You may need to stop taking certain medications that could affect the therapy, like amphetamines or dopamine. It's best to discuss your current medications with the trial team to see if any changes are needed.

What prior data suggests that the PAVE System is safe for treating visual field loss?

Research has shown that the PAVE System, which uses a virtual reality headset to assist people with vision loss, has been generally well-received in past studies. This system aims to improve vision through visual exercises, and research has examined its effects on sight and quality of life.

No specific side effects have been reported, and the treatment is expected to be low-risk. Virtual reality technology is widely used and generally safe, making the PAVE System a promising option for those considering joining a trial to improve their vision. Potential participants should discuss any concerns with the trial team to ensure the treatment is suitable for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PAVE System for visual field loss because it introduces a novel approach using virtual reality technology. Unlike standard treatments like vision therapy exercises or magnification aids, the PAVE System uses a unique parallactic visual-field enhancement technique. This method aims to improve visual field awareness by providing a dynamic and immersive experience through a virtual reality headset. This innovative approach could offer a significant advantage in enhancing visual perception more effectively and engagingly.

What evidence suggests that the PAVE System is effective for visual field loss?

Research has shown that vision problems can improve by helping the brain reorganize itself, a process known as neuroplasticity. In this trial, participants in the test arm will use the PAVE System, which employs a virtual reality headset to provide visual exercises that might expand a person's field of vision. Previous studies have found that patients notice improvements in their vision after similar visual training methods. This suggests that the PAVE System could potentially help people with vision loss due to stroke or brain injury. While specific data on PAVE is limited, the concept is supported by research on the brain's ability to recover and enhance vision. ^{1 2 6 7 8}

Who Is on the Research Team?

DeAnn Fitzgerald, Doctor of Optometry

Principal Investigator

Dr. D. M. Fitzgerald & Associates

Are You a Good Fit for This Trial?

This trial is for individuals with chronic visual field loss due to stroke, traumatic brain injury, or brain surgery. Participants will use a virtual reality headset as part of the PAVE treatment and must be able to attend weekly sessions at the investigator's office for up to 24 weeks.

Inclusion Criteria

It's been 6 months to 5 years since my stroke, brain injury, or brain surgery.

I have been diagnosed with a specific type of vision loss.

Exclusion Criteria

Use of life supporting external medical device such as infusion pumps, ventricular assist devices, etc.

Concurrent use of another visual therapy

Insufficient fixation ability

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly therapy sessions using the PAVE system or placebo for a minimum of 8 weeks and a maximum of 24 weeks

8-24 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including visual field measurement and NEI-VFQ assessment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PAVE (Parallactic Visual-Field Enhancement) System

Trial Overview The study tests if the PAVE System improves visual fields more than a placebo. It involves weekly therapy using a VR headset, with regular assessments of vision area and subjective visual function over an eight to twenty-four-week period.

How Is the Trial Designed?

Group I: Test Experimental Treatment 1 Intervention

Weekly treatment using actual PAVE therapy software operating on a virtual reality head mounted display.

Group II: Control Placebo Group 1 Intervention

Weekly treatment using a placebo that include PAVE software absent the functional component, operating on a virtual reality head mounted display.

Who Is Running the Clinical Trial?

NeuroAEye LLC

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07185971

PAVE (Parallactic Visual-Field Enhancement) System for ... This is a research study to evaluate the effectiveness of the PAVE (Parallactic Visual-Field Enhancement) System for the treatment of chronic visual field ...

2. ctv.veeva.com ctv.veeva.com/study/pave-parallactic-visual-field-enhancement-system-for-treatment-of-chronic-visual-field-loss-due-to

PAVE (Parallactic Visual-Field Enhancement) System for Treatment ... This is a research study to evaluate the effectiveness of the PAVE (Parallactic Visual-Field Enhancement) System for the treatment of chronic visual field ...

3. withpower.com withpower.com/trial/phase-homonymous-hemianopsia-8-2025-bdbb0

PAVE System for Visual Field Loss · Info for Participants This is a research study to evaluate the effectiveness of the PAVE (Parallactic Visual-Field Enhancement) System for the treatment of chronic visual field ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10339290/

Placebo effect after visual restitution training: no eye-tracking ... Analysis showed that patients' mean self-assessment of their subjective visual field size indicated statistically significant improvement while, ...

5. journals.lww.com journals.lww.com/nrronline/fulltext/2020/15100/reversibility_of_visual_field_defects_through.4.aspx

Reversibility of visual field defects through induction of... Visual field defects in glaucoma, diabetic retinopathy or optic neuropathy can be improved by inducing neuroplasticity.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2731547/

Severity of Visual Field Loss and Health Related Quality of Life To examine the association between severity of visual field loss (VFL) and self-reported health-related quality of life (HRQOL) in a population-based sample.

7. ieeexplore.ieee.org ieeexplore.ieee.org/iel8/6287639/10820123/11050387.pdf

Vision-Based Automated Pavement Distress Inspection It consolidates findings on the use of cameras as vision sensors for image data acquisition, sensor calibration techniques, AI-based methods for ...

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0240509

Mobility improvement of patients with peripheral visual field ... AR DSpecs may improve walking maneuverability of patients with peripheral VF defects by enhancing detection of objects in a testing environment.