Blindness, AcquiredNCT06117332
AI-Powered Artificial Vision for Visual Prostheses
A study testing Visual prosthesis in people with Blindness, Acquired, run by University of California, Santa Barbara at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blindness, Acquired
- What is being tested?
- Visual prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 Oct 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
University of California, Santa Barbara
Santa Barbara, California, 93106
About this study
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).
Read the detailed description
The investigators will perform basic experimental studies involving humans (BESH) designed to quantify the perceptual experiences of visual prosthesis patients. These experiments will follow standard procedures for collecting behavioral data, and involve simple perceptual tasks (e.g., signal detection, object recognition) and behavioral tasks (e.g., walking towards a goal location).
The investigators will produce visual percepts in visual prosthesis patients either by directly stimulating electrodes (using standard, safe 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 methods to e.g. highlight important objects in the scene or machine learning to tailor stimuli to each individual patient. Performance of prosthesis patients will be compared both across stimulus encoding methods and to performance in normally sighted control subjects viewing stimuli manipulated to match the expected perceptual experience of prosthesis patients.
The normal method of stimulation is a chain from a camera mounted on eye glasses through a video processing unit (VPU) which converts the video image into electronic pulse trains. Sometimes the investigators will test subjects using the camera. More often, the investigators will carry out 'direct stimulation' when using an external computer to directly specify pulse trains (e.g., a 300 Hz pulse train with 400 us pulse duration). These direct pulse trains are then sent to the VPU. This VPU contains software that makes sure that these pulse trains are within FDA-approved safety limits. For example, these pulses must be charge-balanced (equal anodic/cathodic charge) and must have a charge density below 35 microCoulombs/cm2. Sometimes the investigators will test subjects using the camera. Sometimes the investigators will directly send pulses to the VPU by directly specifying pulse trains (e.g., send a 1 s 10 Hz cathodic pulse train, with a current amplitude of 100 microAmps and a pulse width of 45 microAmps to Electrode 12 of an Argus II implant).
Important parameters for safety include a) pulses must be charge-balanced (an anodic pulse must be followed quickly by a cathodic pulse and vice versa or the electrode will dissolve), b) charge density should be limited. The frequency of the pulse train and the current amplitude of the pulse train is not actually a critical safety issue, since the electronic/neural interface is robust to extremely high rates of stimulation and high current levels. However, high frequency pulse trains or high amplitude pulse trains can produce discomfort in patients (analogous to going from a dark movie theatre to sunlight) due to inducing large-scale neuronal firing. The investigators will normally be focusing on pulse-train frequencies/amplitudes that are in the normal range used by the patient when using their device. If the investigators use parameters that might be expected to produce a more intense neural response (and therefore have the potential to cause discomfort), they will always introduce them in a step-wise function (e.g. gradually increasing amplitude) while checking that the sensation is not 'uncomfortably bright', and the investigators will immediately decrease the intensity of stimulation if patients report that the sensation approaches discomfort. The PI has experience in this approach and will train all personnel on these protocols.
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.
None of these stimuli will elicit emotional responses or be aversive in any way.
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.
Subjects are encouraged to take breaks as often as needed (they may leave the testing room). The investigators use various experimental techniques including: (1) Same-different - e.g. subjects are shown two percepts and are asked if they are the same or different. (2) Method of adjustment - e.g. subjects are asked to adjust a display/stimulation intensity until a percept is barely visible, (3) 2-alternative-forced choice - e.g. subjects will be presented with two stimuli and asked which of the two stimuli is brighter (4) Identification - subjects are asked to identify which letter was presented.
In some cases, as well as measuring accuracy, the investigators will also measure improvement with practice by repeating the same task across multiple sessions (up to 5 sessions, each carried out on different testing days).
- Conditions
- Blindness, Acquired
- Being tested
- Visual prosthesis
- Medical subject headings
- Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual prosthesisDevice
Also called Utah array (Cortivis)
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 group | Role | What they receive |
|---|---|---|
| Perception resulting from AI-powered artificial vision | Experimental | 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. Receives: Device: Visual prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phosphene shape
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).
Measured: through study completion, an average of 1 year
Pattern discrimination accuracy
The effect of stimulation strategy on the ability to discriminate patterns (accuracy, precision, recall) elicited by electrical stimulation as assessed by verbal responses
Measured: through study completion, an average of 1 year
Scene understanding performance
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start2 Oct 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blindness, AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Santa Barbara
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Miguel Hernandez de Elche
- Responsible party
- Sponsor
- Investigators
- Michael Beyeler, PhD, Principal investigator, University of California, Santa Barbara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117332
- Sponsor's protocol ID
- DP2LM014268
- Status last verified
- Aug 2026
- First submitted
- 25 Oct 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Powered Artificial Vision for Visual Prostheses
- ClinicalTrials.gov ID
- NCT06117332
- Acronym / sponsor ID
- DP2LM014268
- Conditions
- Blindness, Acquired
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- University of California, Santa BarbaraUniversity, hospital or other
- Collaborators
- Universidad Miguel Hernandez de Elche
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The investigators will perform basic experimental studies involving humans (BESH) designed to quantify the perceptual experiences of visual prosthesis patients. These experiments will follow standard procedures for collecting behavioral data, and involve simple perceptual tasks (e.g., signal detection, object recognition) and behavioral tasks (e.g., walking towards a goal location).
The investigators will produce visual percepts in visual prosthesis patients either by directly stimulating electrodes (using standard, safe 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 methods to e.g. highlight important objects in the scene or machine learning to tailor stimuli to each individual patient. Performance of prosthesis patients will be compared both across stimulus encoding methods and to performance in normally sighted control subjects viewing stimuli manipulated to match the expected perceptual experience of prosthesis patients.
The normal method of stimulation is a chain from a camera mounted on eye glasses through a video processing unit (VPU) which converts the video image into electronic pulse trains. Sometimes the investigators will test subjects using the camera. More often, the investigators will carry out 'direct stimulation' when using an external computer to directly specify pulse trains (e.g., a 300 Hz pulse train with 400 us pulse duration). These direct pulse trains are then sent to the VPU. This VPU contains software that makes sure that these pulse trains are within FDA-approved safety limits. For example, these pulses must be charge-balanced (equal anodic/cathodic charge) and must have a charge density below 35 microCoulombs/cm2. Sometimes the investigators will test subjects using the camera. Sometimes the investigators will directly send pulses to the VPU by directly specifying pulse trains (e.g., send a 1 s 10 Hz cathodic pulse train, with a current amplitude of 100 microAmps and a pulse width of 45 microAmps to Electrode 12 of an Argus II implant).
Important parameters for safety include a) pulses must be charge-balanced (an anodic pulse must be followed quickly by a cathodic pulse and vice versa or the electrode will dissolve), b) charge density should be limited. The frequency of the pulse train and the current amplitude of the pulse train is not actually a critical safety issue, since the electronic/neural interface is robust to extremely high rates of stimulation and high current levels. However, high frequency pulse trains or high amplitude pulse trains can produce discomfort in patients (analogous to going from a dark movie theatre to sunlight) due to inducing large-scale neuronal firing. The investigators will normally be focusing on pulse-train frequencies/amplitudes that are in the normal range used by the patient when using their device. If the investigators use parameters that might be expected to produce a more intense neural response (and therefore have the potential to cause discomfort), they will always introduce them in a step-wise function (e.g. gradually increasing amplitude) while checking that the sensation is not 'uncomfortably bright', and the investigators will immediately decrease the intensity of stimulation if patients report that the sensation approaches discomfort. The PI has experience in this approach and will train all personnel on these protocols.
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.
None of these stimuli will elicit emotional responses or be aversive in any way.
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.
Subjects are encouraged to take breaks as often as needed (they may leave the testing room). The investigators use various experimental techniques including: (1) Same-different - e.g. subjects are shown two percepts and are asked if they are the same or different. (2) Method of adjustment - e.g. subjects are asked to adjust a display/stimulation intensity until a percept is barely visible, (3) 2-alternative-forced choice - e.g. subjects will be presented with two stimuli and asked which of the two stimuli is brighter (4) Identification - subjects are asked to identify which letter was presented.
In some cases, as well as measuring accuracy, the investigators will also measure improvement with practice by repeating the same task across multiple sessions (up to 5 sessions, each carried out on different testing days).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perception resulting from AI-powered artificial vision | Experimental | Device: Visual prosthesisThe 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual prosthesisAlso: Utah array (Cortivis)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. | Device | Perception resulting from AI-powered artificial vision |
Primary outcome
Phosphene shape
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Beyeler, PhD principal investigator
University of California, Santa Barbara
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual prosthesis in people with Blindness, Acquired, run by University of California, Santa Barbara at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phosphene shape (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.