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| ID | Type | Description | Link |
|---|---|---|---|
| R00EY029329 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| University of Michigan | OTHER |
| National Eye Institute (NEI) | NIH |
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This Basic Experimental Studies Involving Humans (BESH) study investigates phosphene perception and performance factors in blind participants implanted with the Argus II retinal prosthesis system. Using paired-electrode stimulation, we analyze how phosphene shape and number are influenced by neuroanatomical factors, stimulus parameters, and spatial offsets. Additionally, we examine the causes of high current thresholds and limited spatial resolution, which impede pattern vision in Argus II devices. This research aims to provide insights for optimizing stimulation strategies and improving retinal prosthesis design.
This study focuses on two experiments involving blind participants implanted with the Argus II retinal prosthesis:
Experiment 1: Paired-Electrode Phosphene Perception The study retrospectively analyzes 3548 phosphene drawings made by three participants. We investigate the impact of single- and paired-electrode stimulation on phosphene shape (area, perimeter, major/minor axis length) and the number of perceived phosphenes. Neuroanatomical parameters, including electrode-retina distance, electrode-fovea distance, and electrode-electrode distance (both along-axon and between-axon), are correlated with these outcomes. Statistical analyses include linear regression and partial correlation to examine the relationship between stimulation parameters and phosphene perception.
Experiment 2: Performance Factors in Argus II Prostheses This study explores the factors contributing to high current amplitude thresholds and poor spatial resolution in three participants. We measure current amplitude thresholds and two-point discrimination (the ability to distinguish stimulation on one versus two electrodes). Data from psychophysical experiments and simulations are analyzed to identify the roles of axonal stimulation, electrode lift, and retinal damage in limiting device performance.
These experiments aim to advance the understanding of epiretinal stimulation and inform the development of future retinal prostheses with improved spatial resolution and sensitivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Argus II users | Experimental | This Basic Experimental Studies Involving Humans (BESH) study investigates phosphene perception and performance factors in blind participants implanted with the Argus II retinal prosthesis system. Using paired-electrode stimulation, we analyze how phosphene shape and number are influenced by neuroanatomical factors, stimulus parameters, and spatial offsets. Additionally, we examine the causes of high current thresholds and limited spatial resolution, which impede pattern vision in Argus II devices. This research aims to provide insights for optimizing stimulation strategies and improving retinal prosthesis design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Argus II | Device | Participants used the Argus II retinal prosthesis system in both experiments to perform visual perception tasks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Phosphenes Perceived | Number of phosphenes perceived in response to paired-electrode stimulation across 5 spatial distances and 7 temporal interpulse delays. Phosphenes are brief sensations of light or visual flashes that occur in the absence of an external light source. A response is counted as a phosphene if the participant reports any visual sensation consistent with a flash of light. | during single-session testing |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Beyeler, PhD | University of California, Santa Barbara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Santa Barbara | Santa Barbara | California | 93106 | United States | ||
| Johns Hopkins University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36090266 | Result | Yucel EI, Sadeghi R, Kartha A, Montezuma SR, Dagnelie G, Rokem A, Boynton GM, Fine I, Beyeler M. Factors affecting two-point discrimination in Argus II patients. Front Neurosci. 2022 Aug 24;16:901337. doi: 10.3389/fnins.2022.901337. eCollection 2022. | |
| 38457841 | Result | Hou Y, Nanduri D, Granley J, Weiland JD, Beyeler M. Axonal stimulation affects the linear summation of single-point perception in three Argus II users. J Neural Eng. 2024 Apr 8;21(2):026031. doi: 10.1088/1741-2552/ad31c4. |
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Deidentified data will be available from the investigative team, following initial publication of the results
Spring 2023 onward
Any researchers with a legitimate reason for wishing to re-analyze the data or compare them to study data collected in similar experiments
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| ID | Title | Description |
|---|---|---|
| FG000 | Argus II Users | This Basic Experimental Studies Involving Humans (BESH) study investigates phosphene perception and performance factors in blind participants implanted with the Argus II retinal prosthesis system. Using paired-electrode stimulation, we analyze how phosphene shape and number are influenced by neuroanatomical factors, stimulus parameters, and spatial offsets. Additionally, we examine the causes of high current thresholds and limited spatial resolution, which impede pattern vision in Argus II devices. This research aims to provide insights for optimizing stimulation strategies and improving retinal prosthesis design. Argus II: Participants used the Argus II retinal prosthesis system in both experiments to perform visual perception tasks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Argus II Users | Blind individuals previously implanted with the Argus II retinal prosthesis system participated in two experiments. The first experiment tested phosphene perception by varying the spatial offsets and temporal delays between pairs of electrodes. The second experiment tested the effect of gamification on circle localization and motion discrimination tasks. Argus II: Participants used the Argus II retinal prosthesis system in both experiments to perform visual perception tasks. Gamification: Participants performed gamified versions of circle localization and motion discrimination tasks designed to improve engagement and task performance. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Phosphenes Perceived | Number of phosphenes perceived in response to paired-electrode stimulation across 5 spatial distances and 7 temporal interpulse delays. Phosphenes are brief sensations of light or visual flashes that occur in the absence of an external light source. A response is counted as a phosphene if the participant reports any visual sensation consistent with a flash of light. | Data were collected in 6 participants ranging in age from 45 to 88 years old. One participant was female. All identified as white, non-hispanic. | Posted | Mean | Standard Deviation | number of phosphenes | during single-session testing |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Argus II Users | Blind individuals previously implanted with the Argus II retinal prosthesis system were invited to join the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Beyeler | University of California, Santa Barbara | (805) 893-4321 | mbeyeler@ucsb.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 24, 2021 | Nov 27, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2021 | Nov 27, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 11, 2021 | Nov 27, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
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| Baltimore |
| Maryland |
| 21287 |
| United States |
| University of Michigan, Ann Arbor | Ann Arbor | Michigan | 48109 | United States |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
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| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |