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Enrolling by invitation Not applicable

AI-Powered Artificial Vision for Visual Prostheses

NCT06117332 · tracked via the Priya Life Science Spain tracker
Sponsor
University of California, Santa Barbara
Phase
Not applicable
Started
2023-10-02
Last updated
2026-08-20

Condition(s) studied

Blindness, Acquired

Investigational drug(s) / intervention(s)

Visual prosthesis

Visual prosthesis: In response to the stimulation/image on the monitor, subjects will be asked to either make a perceptual judgment or perform a simple behavioral task. Examples include detecting a stimulus ('did you see a light on that trial'), reporting size by drawing on a touch screen, or walking to a target location. Both patient response and reaction time will be recorded. In some cases, the investigators will also collect data measuring subjects' eye position. This is a noninvasive procedure that will be carried out using standard eye-tracking equipment via an infra-red camera that tracks the position of the subjects' pupil. Only measurements like eye position or eye blinks will be recorded, so these data do not contain identifiable information.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Criteria for inclusion of visual prosthesis users: * Subject must be at least 18 years of age; * Subject has been implanted with a visual prosthesis (e.g., Argus II, Orion, Cortivis) * Subject has healed from surgery and the surgeon has cleared the subject for programming; * Subject has the cognitive and communication ability to participate in the study (i.e., follow spoken directions, perform tests, and give feedback); * Subject is willing to conduct psychophysics testing up to 4-6 hours per day of testing on 3-5 consecutive days; * Subject is capable of understanding patient information materials and giving written informed consent; * Subject is able to walk unassisted. Criteria for inclusion of sighted control subjects: * Subject speaks English; * Subject must be at least 18 years of age; * Subject has visual acuity of 20/40 or better (corrected); * Subject has the cognitive and communication ability to participate in the study (i.e., follow spoken directions, perform tests, and give feedback); * Subject is capable of understanding participant information materials and giving written informed consent. * Subject is able to walk unassisted Exclusion criteria: * Visual prosthesis users: Subject is unwilling or unable to travel to testing facility for at least 3 days of testing within a one-week timeframe; * Sighted controls: Subject has a history of motion sickness or flicker vertigo * All: Subject has language or hearing impairment

Primary outcome measure(s)

  • Phosphene shape — through study completion, an average of 1 year
    The effect of stimulation strategy on the shape of phosphenes elicited by electrical stimulation. Phosphene shape will be recorded via participant drawings on a touchscreen and quantified using image moments (e.g., area, orientation, eccentricity).
  • Pattern discrimination accuracy — through study completion, an average of 1 year
    The effect of stimulation strategy on the ability to discriminate patterns (accuracy, precision, recall) elicited by electrical stimulation as assessed by verbal responses
  • Scene understanding performance — through study completion, an average of 1 year
    The effect of stimulation strategy to locate objects of interest (accuracy, precision, recall) and relay accurate descriptions of the visual scene as assessed by verbal responses

Trial sites (2)

FacilityCityRegionStatus
University of California, Santa Barbara Santa Barbara California
University Miguel Hernandez Elche Alicante
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06117332 on ClinicalTrials.gov ↗ ← All trials in Spain