Smart Bionic Eye for Blindness

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Santa Barbara

Disqualifiers: Motion sickness, Flicker vertigo, others

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

Trial Summary

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 treatment Visual Prosthesis in the Smart Bionic Eye for Blindness trial?

Research shows that bionic eyes, or vision prostheses, have been tested in humans and can help people with profound vision loss detect objects, count them, and recognize movement. These devices are already available in some regions, indicating their potential to restore basic sight.¹ ² ³ ⁴ ⁵

Is the Smart Bionic Eye generally safe for humans?

Research on bionic eyes, including retinal prostheses, shows that safety features are a key focus, with devices having regulatory approvals in the US and Europe. Safety measures include monitoring electrode voltage, limiting stimulus charge, and error checking, which help ensure safe use in humans.¹ ² ⁵ ⁶ ⁷

How is the Smart Bionic Eye treatment different from other treatments for blindness?

The Smart Bionic Eye treatment is unique because it uses a sophisticated visual prosthesis that involves implanting a device to electrically stimulate the retina, potentially restoring basic vision to those with profound vision loss. Unlike other treatments, it focuses on using advanced technology like high-voltage CMOS transistors and a unique electrode system to provide precise and simultaneous stimulation, aiming to improve visual function beyond current capabilities.¹ ⁸ ⁹ ¹⁰ ¹¹

What is the purpose of this trial?

Visual impairment is one of the ten most prevalent causes of disability and poses extraordinary challenges to individuals in our society that relies heavily on sight. Living with acquired blindness not only lowers the quality of life of these individuals, but also strains society's limited resources for assistance, care and rehabilitation. However, to date, there is no effective treatment for man patients who are visually handicapped as a result of degeneration or damage to the inner layers of the retina, the optic nerve or the visual pathways. Therefore, there are compelling reasons to pursue the development of a cortical visual prosthesis capable of restoring some useful sight in these profoundly blind patients.However, the quality of current prosthetic vision is still rudimentary. A major outstanding challenge is translating electrode stimulation into a code that the brain can understand. Interactions between the device electronics and the retinal neurophysiology lead to distortions that can severely limit the quality of the generated visual experience. Rather than aiming to one day restore natural vision (which may remain elusive until the neural code of vision is fully understood), one might be better off thinking about how to create practical and useful artificial vision now.The goal of this work is to address fundamental questions that will allow the development of a Smart Bionic Eye, a device that relies on AI-powered scene understanding to augment the visual scene (similar to the Microsoft HoloLens), tailored to specific real-world tasks that are known to diminish the quality of life of people who are blind (e.g., face recognition, outdoor navigation, reading, self-care).

Research Team

Michael Beyeler, PhD

Principal Investigator

University of California, Santa Barbara

Eligibility Criteria

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.

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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

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

Treatment Details

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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Perception resulting from AI-powered artificial visionExperimental Treatment1 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.