Smart Bionic Eye for Blindness

Enrolling by invitation at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Santa Barbara

Disqualifiers: Motion sickness, Flicker vertigo, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial focuses on developing a Smart Bionic Eye, a device that uses artificial intelligence to help people with severe blindness regain some sight. The goal is to enhance daily tasks such as recognizing faces, navigating outdoors, reading, and self-care by creating an improved visual experience. The trial tests various methods of translating images into brain signals to aid these tasks. It seeks participants who have already been fitted with a visual prosthesis (an implanted device that aids vision) and have healed from surgery. Participants should be able to follow instructions, perform tests, and walk without assistance. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could transform the lives of those with severe blindness.

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 prior data suggests that this device is safe for visual prosthesis patients?

Research has shown that visual prostheses, devices that can help restore some vision, have been safe in early studies. Initial tests on animals demonstrated their safety, prompting further research on these devices.

In humans, studies have assessed the safety of these devices by monitoring serious side effects over time. These studies aim to identify any serious problems early. So far, evidence suggests that visual prostheses are generally safe, with no major safety issues reported.

Overall, while more research is needed, current findings are promising for those considering participation in a clinical trial for a visual prosthesis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smart Bionic Eye because it uses an AI-powered visual prosthesis to help blind individuals perceive their surroundings. Unlike traditional options like guide dogs or canes, which assist with navigation but don't provide visual information, this treatment directly stimulates the brain's visual pathways. The prosthetic system leverages computer vision and machine learning to highlight important objects and obstacles, potentially allowing for improved object recognition and navigation. This approach offers a novel way to restore a form of vision, representing a significant leap forward in assistive technology for blindness.

What evidence suggests that this Smart Bionic Eye is effective for blindness?

Research has shown that devices like the Visual Prosthesis in this trial can help people with severe blindness regain some vision. In one study, 81% of participants who received a special implant in their eye experienced clearer vision within a year. Another study found that a wireless eye device helped people with advanced vision loss from macular degeneration see well enough to perform daily activities. These devices convert images into signals that the brain can understand, potentially aiding in object recognition and mobility. Although these vision aids are not yet perfect, technological advancements are enhancing their effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael Beyeler, PhD

Principal Investigator

University of California, Santa Barbara

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had a visual prosthesis implanted, are healed from the surgery, and can follow directions for tests. They must be able to see at least 20/40 with correction, walk without help, speak English, and commit to several days of testing.

Inclusion Criteria

I am willing to undergo testing for 4-6 hours a day over 3-5 days.

I understand the study information and can give my consent in writing.

I can walk without help.

Exclusion Criteria

I cannot or do not want to travel to the testing facility for 3 days within a week.

I have experienced motion sickness or flicker vertigo.

Subject has language or hearing impairment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Studies

Basic experimental studies involving perceptual and behavioral tasks with visual prosthesis patients

12 months

Multiple sessions across different testing days

Follow-up

Participants are monitored for safety and effectiveness after experimental studies

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Visual Prosthesis

Trial Overview The study is testing a 'Smart Bionic Eye', an AI-powered device designed to enhance vision for specific tasks like face recognition and navigation. It aims to improve life quality by providing practical artificial vision.

How Is the Trial Designed?

Group I: Perception resulting from AI-powered artificial vision Experimental Treatment 1 Intervention

The investigators will produce visual percepts in visual prosthesis patients either by directly stimulating electrodes (using FDA-approved pulse trains), or by asking them to view a computer or projector screen and using standard stimulation protocols (as is standardly used for their devices) to convert the computer or projector screen image into pulse trains on their electrodes. Informed by psychophysical data and computational models, the investigators will test the ability of different stimulus encoding methods to support simple perceptual and behavioral tasks (e.g., object recognition, navigation). These encoding methods may include computer vision and machine learning methods to highlight important objects in the scene or to highlight nearby obstacles and may be tailored to each individual patient.

Who Is Running the Clinical Trial?

University of California, Santa Barbara

Lead Sponsor

Trials

33

Recruited

3,100+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Neuralink Corp

Industry Sponsor

Trials

3

Recruited

10+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Universidad Miguel Hernandez de Elche

Collaborator

Trials

96

Recruited

1,838,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4921351/

Visual Prosthesis: Artificial Vision - PMC - PubMed Central - NIH Incidentally, RP is the leading inherited cause of blindness, with 1.5 million people affected worldwide [2]. AMD seen in adults over 65 years is the leading ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2501396

Subretinal Photovoltaic Implant to Restore Vision in ... Visual acuity improved from baseline to month 12 after implantation by at least 0.2 logMAR (≥10 letters) in 81% of the participants and by at ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12405713/

Visual Prostheses in the Era of Artificial Intelligence Technology Evaluation with data from a visual prosthesis was conducted in 7 studies, including 1 that was prospectively assessed with a human RCP.

4. med.stanford.edu med.stanford.edu/news/all-news/2025/10/eye-prosthesis.html

Eye prosthesis is the first to restore sight lost to macular ... In a Stanford Medicine-led clinical trial of a wireless retinal prosthesis, people with advanced macular degeneration regained enough vision ...

5. journals.plos.org journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.3002896

Advances and challenges in the development of visual ... The early 2000s marked the beginning of tangible progress in visual prostheses development, particularly with the emergence of retinal implants.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06117332

AI-Powered Artificial Vision for Visual Prostheses The investigators will perform basic experimental studies involving humans (BESH) designed to quantify the perceptual experiences of visual prosthesis patients.

7. journalretinavitreous.biomedcentral.com journalretinavitreous.biomedcentral.com/articles/10.1186/s40942-023-00498-1

An update on visual prosthesis This review provides an update of retinal prosthetic devices, both current and discontinued. While some devices have achieved visual perception in animals and/ ...