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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01EY029741-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Carnegie Mellon University | OTHER |
| National Eye Institute (NEI) | NIH |
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This study is driven by the hypothesis that independent navigation by blind users of visual prosthetic devices can be greatly aided by use of an autonomous navigational aid that provides information about the environment and guidance for navigation through multimodal sensory cues. For this study, the investigators developed a navigation system that uses on-board sensing to map the user's environment and compute navigable paths to desired destinations in real-time. Information regarding obstacles and directional guidance is communicated to the user via a combination of sensory modalities including limited vision (through the user's visual prosthesis), haptic, and audio cues. This study evaluates how effectively this navigational aid improves prosthetic vision users' ability to perform navigational tasks. The participants for this study include both retinal prosthesis users of the Argus II Retinal Prosthesis System (Argus II) and normally sighted individuals who use a virtual reality headset to simulate the limited vision of the Argus II system.
About 1.3 million Americans aged 40 and older are legally blind, a majority because of diseases with onset later in life, such as glaucoma and age-related macular degeneration. Second Sight Medical Products (SSMP) has developed the world's first FDA approved retinal implant, Argus II, intended to restore some functional vision for people suffering from retinitis pigmentosa (RP).
In this era of smart devices, generic navigation technology, such as GPS mapping apps for smartphones, can provide directions to help guide a blind user from point A to point B. However, these navigational aids do little to enable blind users to form an egocentric understanding of the surroundings, are not suited to navigation indoors, and do nothing to assist in avoiding obstacles to mobility. The Argus II, on the other hand, provides blind users with a limited visual representation of the users surroundings that improves users' ability to orient themselves and traverse obstacles, yet lacks features for high-level navigation and semantic interpretation of the surroundings. The proposed study aims to address these limitations of the Argus II through a synergy of state-of-the-art simultaneous localization and mapping (SLAM) and scene recognition technologies.
This study is driven by the hypothesis that independent navigation by blind users of visual prosthetic devices can be greatly aided by use of an autonomous navigational aid that provides information about the environment and guidance for navigation through multimodal sensory cues. The investigators developed a navigation system that uses on-board sensing and SLAM-based algorithms to continuously construct a map of the user's environment and locate the user within that map in real-time. On-board path planning algorithms compute optimal navigation routes to reach desired destinations based on the constructed map. The system then communicates obstacle locations and navigational cues to the user while navigating via a combination of sensory modalities. The participants for this study include blind Argus II users, who use their retinal implant for vision, and normally sighted individuals, who use a virtual reality headset to simulate the limited vision of a retinal prosthesis.
The sensory modalities used by the navigational aid to communicate information back to the user include:
This study compares participants' performance in completing navigation tasks using five different modes and combinations of the foregoing sensory modalities as follows: 1) Argus vision, 2) depth vision, 3) depth vision with haptic and audio, 4) haptic and audio (without vision), and 5) high field-of-view depth vision.
The navigation tasks performed by the participants using these modalities include navigating through a dense obstacle field and navigating between rooms within an indoor facility that requires successful traversal of non-trivial paths.
In addition, a third experiment evaluates the effect of resolution and field-of-view of the retinal implant upon participants' ability to visually discern relative distances to different obstacles based on optical flow patterns induced by the participant's motion when approaching obstacles situated at different distances ahead of the user. For this experiment, the following four vision settings are evaluated: 1) low resolution / low field-of-view, 2) low resolution / high field-of-view, 3) high resolution / low field-of-view, and 4) high resolution / high field-of-view. The "low" settings correspond to the values of the Argus II system, whereas the "high" settings corresponding to a doubling of the "low" values along each dimension. For Argus user participants, only the low resolution / low field-of-view setting is evaluated since the Argus II retinal implant is incapable of supporting the higher vision settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation of normally sighted participants using a simulated visual prosthesis | Experimental | All normally sighted participants will be assigned to this arm of the study. This study group will perform all experiments using a virtual reality headset (Oculus Go) to simulate the limited vision of a retinal prosthesis system. This study group will include all interventions, including those that both match and exceed the visual performance of the Argus II system. |
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| Evaluation of blind participants using the Argus II retinal prosthesis | Experimental | All blind participants who have been implanted with the Argus II Retinal Prosthesis System will be assigned to this arm of the study. This study group will be limited to performing a subset of the interventions including only those that do not exceed the visual performance of the Argus II system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigation system mode: Argus Vision | Device | This intervention uses the navigational aid with the output sensory modalities configured as follows:
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| Measure | Description | Time Frame |
|---|---|---|
| Duration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in Meters | Participants will be asked to complete the navigation tasks of crossing an obstacle field approximately 6 meters in length and navigating to a target destination located about 20 - 30 meters away. The normalized duration of time to complete each navigation task will be measured in seconds. To account for variability in the path distances of different trials, the measured time will be normalized by a reference (nominal) path distance in meters associated with the configuration of each trial. The mean normalized time across all trials will be computed for each intervention. | Up to 7 minutes for each navigation task, on Day 1 or Day 2 |
| Distance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in Meters | Participants will be asked to complete the navigation tasks of crossing an obstacle field approximately 6 meters in length and navigating to a target destination located about 20 - 30 meters away. The normalized distance traversed to complete each navigation task will be measured. To account for variability in the path distances of different trials, the measured distance will be normalized by a reference (nominal) path distance in meters associated with the configuration of each trial. The mean normalized distance across all trials will be computed for each intervention. | Up to 7 minutes for each navigation task, on Day 1 or Day 2 |
| Obstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in Meters | Participants will be asked to complete the navigation tasks of crossing an obstacle field approximately 6 meters in length and navigating to a target destination located about 20 - 30 meters away. The number of contacts with obstacles encountered while completing each navigation task will be measured. To account for variability in the path distances of different trials, the number of contacts will be normalized by a reference (nominal) path distance in meters associated with the configuration of each trial. The mean normalized number of contacts with obstacles across all trials will be computed for each intervention. |
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Criteria for inclusion of normally sighted individuals:
Criteria for inclusion of Argus II users:
The inclusion criteria for the study are the following:
Exclusion criteria for all subjects is the following:
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| Name | Affiliation | Role |
|---|---|---|
| Seth Billings, Ph.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medicine - Wilmer Eye Institute | Baltimore | Maryland | 21205 | United States | ||
| Johns Hopkins Applied Physics Laboratory |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41587489 | Derived | Christie B, Acosta NN, Sadeghi R, Kartha A, Ewulum C, Caspi A, Tenore FV, Dagnelie G, Klatzky RL, Billings SD. Autonomous multisensory enhancement of a visual neuroprosthesis for navigation: technical proof-of-concept with simulated prosthetic vision and single-subject case study of a visual prosthesis user. J Neural Eng. 2026 Feb 5;23(1). doi: 10.1088/1741-2552/ae3d67. |
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Results from this study will be disseminated through conference presentations and peer-reviewed publications. However, IPD will not be shared outside the study team.
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For blind participants, 6 individuals who had previously received the Argus II retinal implant were recruited.
For sighted participants, 20 individuals with normal vision were recruited from staff members of the Johns Hopkins University Applied Physics Laboratory.
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| ID | Title | Description |
|---|---|---|
| FG000 | Evaluation of Normally Sighted Participants Using a Simulated Visual Prosthesis | All normally sighted participants will be assigned to this arm of the study. This study group will perform all experiments using a virtual reality headset (Oculus Go) to simulate the limited vision of a retinal prosthesis system. This study group will include all interventions, including those that both match and exceed the visual performance of the Argus II system. |
| Title | Milestones | Reasons Not Completed | |||||
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| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2023 |
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| Navigation system mode: Depth Vision | Device | This intervention uses the navigational aid with the output sensory modalities configured as follows:
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| Navigation system mode: Depth Vision with Haptic / Audio | Device | This intervention uses the navigational aid with the output sensory modalities configured as follows:
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| Navigation system mode: Haptic / Audio | Device | This intervention uses the navigational aid with the output sensory modalities configured as follows:
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| Navigation system mode: High Field-of-View Depth Vision | Device | This intervention uses the navigational aid with the output sensory modalities configured as follows:
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| Distance test vision mode: Low Resolution / Low Field-of-View | Device | This intervention performs the relative distance to two obstacles test with the user's vision output configured as follows:
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| Distance test vision mode: Low Resolution / High Field-of-View | Device | This intervention performs the relative distance to two obstacles test with the user's vision output configured as follows:
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| Distance test vision mode: High Resolution / Low Field-of-View | Device | This intervention performs the relative distance to two obstacles test with the user's vision output configured as follows:
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| Distance test vision mode: High Resolution / High Field-of-View | Device | This intervention performs the relative distance to two obstacles test with the user's vision output configured as follows:
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| Up to 7 minutes for each navigation task, on Day 1 or Day 2 |
| Success in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended Destination | Participants will be asked to navigate to a target destination located about 20 - 30 meters away. We will measure success rate as the mean number of trials for which each participants successfully reached the intended destination divided by the total number of trials performed by that participant for each intervention. | Up to 7 minutes for each navigation task, on Day 1 or Day 2 |
| Accuracy of Relative Distance Judgments as Assessed by the Percentage of Correct Responses | Participants will be presented with two physical objects and asked to identify which of the objects is the nearer one after walking a controlled distance down a centerline oriented between the objects. We will measure accuracy as the percentage of correct responses (the total number of correct responses divided by the total number of trials times 100). | Up to 60 seconds for each discrimination task, on Day 1 or Day 2 |
| Laurel |
| Maryland |
| 20723 |
| United States |
| FG001 | Evaluation of Blind Participants Using the Argus II Retinal Prosthesis | All blind participants who have been implanted with the Argus II Retinal Prosthesis System will be assigned to this arm of the study. This study group will be limited to performing a subset of the interventions including only those that do not exceed the visual performance of the Argus II system. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Evaluation of Normally Sighted Participants Using a Simulated Visual Prosthesis | All normally sighted participants will be assigned to this arm of the study. This study group will perform all experiments using a virtual reality headset (Oculus Go) to simulate the limited vision of a retinal prosthesis system. This study group will include all interventions, including those that both match and exceed the visual performance of the Argus II system. |
| BG001 | Evaluation of Blind Participants Using the Argus II Retinal Prosthesis | All blind participants who have been implanted with the Argus II Retinal Prosthesis System will be assigned to this arm of the study. This study group will be limited to performing a subset of the interventions including only those that do not exceed the visual performance of the Argus II system. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Vision Impairment | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Duration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in Meters | Participants will be asked to complete the navigation tasks of crossing an obstacle field approximately 6 meters in length and navigating to a target destination located about 20 - 30 meters away. The normalized duration of time to complete each navigation task will be measured in seconds. To account for variability in the path distances of different trials, the measured time will be normalized by a reference (nominal) path distance in meters associated with the configuration of each trial. The mean normalized time across all trials will be computed for each intervention. | Participants who completed the task are reported | Posted | Mean | Standard Error | seconds/meter | Up to 7 minutes for each navigation task, on Day 1 or Day 2 |
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| Primary | Distance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in Meters | Participants will be asked to complete the navigation tasks of crossing an obstacle field approximately 6 meters in length and navigating to a target destination located about 20 - 30 meters away. The normalized distance traversed to complete each navigation task will be measured. To account for variability in the path distances of different trials, the measured distance will be normalized by a reference (nominal) path distance in meters associated with the configuration of each trial. The mean normalized distance across all trials will be computed for each intervention. | Participants who completed the task are reported | Posted | Mean | Standard Error | meters/meter | Up to 7 minutes for each navigation task, on Day 1 or Day 2 |
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| Primary | Obstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in Meters | Participants will be asked to complete the navigation tasks of crossing an obstacle field approximately 6 meters in length and navigating to a target destination located about 20 - 30 meters away. The number of contacts with obstacles encountered while completing each navigation task will be measured. To account for variability in the path distances of different trials, the number of contacts will be normalized by a reference (nominal) path distance in meters associated with the configuration of each trial. The mean normalized number of contacts with obstacles across all trials will be computed for each intervention. | Participants who completed the task are reported | Posted | Mean | Standard Error | number of contacts / meter | Up to 7 minutes for each navigation task, on Day 1 or Day 2 |
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| Primary | Success in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended Destination | Participants will be asked to navigate to a target destination located about 20 - 30 meters away. We will measure success rate as the mean number of trials for which each participants successfully reached the intended destination divided by the total number of trials performed by that participant for each intervention. | Participants who completed the task are reported | Posted | Mean | Standard Error | percentage of trials | Up to 7 minutes for each navigation task, on Day 1 or Day 2 |
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| Primary | Accuracy of Relative Distance Judgments as Assessed by the Percentage of Correct Responses | Participants will be presented with two physical objects and asked to identify which of the objects is the nearer one after walking a controlled distance down a centerline oriented between the objects. We will measure accuracy as the percentage of correct responses (the total number of correct responses divided by the total number of trials times 100). | Participants who completed the task are reported | Posted | Mean | Standard Error | percentage of correct responses | Up to 60 seconds for each discrimination task, on Day 1 or Day 2 |
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Up to 2 days
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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 | Evaluation of Normally Sighted Participants Using a Simulated Visual Prosthesis | All normally sighted participants will be assigned to this arm of the study. This study group will perform all experiments using a virtual reality headset (Oculus Go) to simulate the limited vision of a retinal prosthesis system. This study group will include all interventions, including those that both match and exceed the visual performance of the Argus II system. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | Evaluation of Blind Participants Using the Argus II Retinal Prosthesis | All blind participants who have been implanted with the Argus II Retinal Prosthesis System will be assigned to this arm of the study. This study group will be limited to performing a subset of the interventions including only those that do not exceed the visual performance of the Argus II system. | 2 | 6 | 0 | 6 | 0 | 6 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seth Billings | Johns Hopkins Applied Physics Laboratory | 240-228-7462 | seth.billings@jhuapl.edu |
| Jan 23, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Blind having Argus II Implant |
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| Obstacle Field Test: Depth Vision + Haptic/Audio |
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| Obstacle Field Test: Haptic/Audio |
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| Obstacle Field Test: High Field-of-View Depth Vision |
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| Navigate to Destination Test: Argus Vision |
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| Navigate to Destination Test: Depth Vision |
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| Navigate to Destination Test: Depth Vision + Haptic/Audio |
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| Navigate to Destination Test: Haptic/Audio |
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| Navigate to Destination Test: High Field-of-View Depth Vision |
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| t-test, 2 sided |
| 0.22 |
| Other |
| Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance | t-test, 2 sided | 0.017 | Other |
| Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance | t-test, 2 sided | 0.98 | Other |
| Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance | t-test, 2 sided | 0.014 | Other |
| Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes | ANOVA | <0.001 | Other |
| Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance | t-test, 2 sided | <0.01 | Other |
| Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance | t-test, 2 sided | 0.156 | Other |
| Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance | t-test, 2 sided | 0.541 | Other |
| Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance | t-test, 2 sided | <0.01 | Other |
| Obstacle Avoidance Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study. | Other | Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects. Significance threshold: |Z| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.10 |
| Obstacle Avoidance Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study. | Other | Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects. Significance threshold: |Z| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.00 |
| Obstacle Avoidance Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study. | Other | Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects. Significance threshold: |Z| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.88 |
| Obstacle Avoidance Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study. | Other | Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects. Significance threshold: |Z| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -1.6 |
| Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study. | Other | Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects. Significance threshold: |Z| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = N/A * * N/A for Argus Vision test because subject did not successfully reach intended destination for any trial using this mode. |
| Navigate to Destination Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study. | Other | Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects. Significance threshold: |Z| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -1.10 |
| Navigate to Destination Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study. | Other | Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects. Significance threshold: |Z| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.45 |
| Navigate to Destination Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study. | Other | Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects. Significance threshold: |Z| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.02 |
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All blind participants who have been implanted with the Argus II Retinal Prosthesis System will be assigned to this arm of the study. This study group will be limited to performing a subset of the interventions including only those that do not exceed the visual performance of the Argus II system.
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