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Environmental Localization Mapping and Guidance for Visual Prosthesis Users

Environmental Localization Mapping and Guidance for Visual Prosthesis Users

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04359108
Acronym
SLAM
Enrollment
26
Registered
2020-04-24
Start date
2021-03-16
Completion date
2024-09-30
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinitis Pigmentosa, Visual Impairment, Visual Prosthesis

Keywords

Retinal Prosthesis, Argus II

Brief summary

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.

Detailed description

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: * Limited vision is provided via the user's visual prosthesis, with the Argus II retinal implant supporting an image size of 10 x 6 pixels spanning approximately 18 x 11 degrees field-of-view. Images sent to the visual implant are derived from video frames provided by forward-facing cameras integrated within headgear worn by the user. Three forms of vision feedback are evaluated in this study including: 1) the standard vision output of the Argus II (which uses texture-based processing including difference-of-Gaussian and contrast enhancement filters), 2) an enhanced depth-based vision mode that uses the depth sensing capabilities of the navigational aid to highlight above-ground obstacles, and 3) a high field of view depth-based vision mode that doubles the pixel size and field of view of the visual feedback in each dimension. The depth-vision modes display only above-ground obstacles with increasing brightness relative to decreasing distance from the user; the ground and obstacles beyond a threshold distance are not displayed in order to declutter the visual scene. The high field-of-view depth-vision mode is only utilized by normally sighted participants, as this mode exceeds the vision capabilities of the Argus II implant. * Haptic cues indicate the direction in which the user should advance in order to follow the path computed by the navigational aid to reach a target destination. The haptic cues are generated by vibrators situated at five positions located left-to-right along the users forehead, which are built into user-worn headgear. The five vibration points indicate for the user to turn in directions: far left, slight left, straight ahead, slight right, and far right. * Audio cues provide an audible alert when the user approaches an obstacle within 1.5 feet and provide verbal updates on the remaining distance to reach the destination along the path computed by the navigational aid. 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.

Interventions

DEVICENavigation system mode: Argus Vision

This intervention uses the navigational aid with the output sensory modalities configured as follows: * Vision: Argus mode * Haptics: none * Audio: none Since this mode only provides the standard Argus vision, it is equivalent to using the base Argus II system without the navigational aid.

DEVICENavigation system mode: Depth Vision

This intervention uses the navigational aid with the output sensory modalities configured as follows: * Vision: Depth mode (at Argus II resolution and field-of-view) * Haptics: none * Audio: none

DEVICENavigation system mode: Depth Vision with Haptic / Audio

This intervention uses the navigational aid with the output sensory modalities configured as follows: * Vision: Depth mode (at Argus II resolution and field-of-view) * Haptics: yes * Audio: yes

DEVICENavigation system mode: Haptic / Audio

This intervention uses the navigational aid with the output sensory modalities configured as follows: * Vision: none * Haptics: yes * Audio: yes Since this mode does not provide any visual feedback, it is equivalent to using navigational aid completely blind without a visual prosthesis.

DEVICENavigation system mode: High Field-of-View Depth Vision

This intervention uses the navigational aid with the output sensory modalities configured as follows: * Vision: High Field-of-View Depth mode (at twice the Argus II resolution and field-of-view along each dimension) * Haptics: none * Audio: none

DEVICEDistance test vision mode: Low Resolution / Low Field-of-View

This intervention performs the relative distance to two obstacles test with the user's vision output configured as follows: * Resolution: Low * Field-of-View: Low

DEVICEDistance test vision mode: Low Resolution / High Field-of-View

This intervention performs the relative distance to two obstacles test with the user's vision output configured as follows: * Resolution: Low * Field-of-View: High

DEVICEDistance test vision mode: High Resolution / Low Field-of-View

This intervention performs the relative distance to two obstacles test with the user's vision output configured as follows: * Resolution: High * Field-of-View: Low

DEVICEDistance test vision mode: High Resolution / High Field-of-View

This intervention performs the relative distance to two obstacles test with the user's vision output configured as follows: * Resolution: High * Field-of-View: High

Sponsors

Carnegie Mellon University
CollaboratorOTHER
National Eye Institute (NEI)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Criteria for inclusion of normally sighted individuals: * Subject speaks English; * Subjects must be an adult (at least 18 years of age); * 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 has visual acuity of 20/40 or better (corrected); * Subject is capable of understanding participant information materials and giving written informed consent. * Subject is able to walk unassisted Criteria for inclusion of Argus II users: The inclusion criteria for the study are the following: * Subject is at least 25 years of age; * Subject has been implanted with the Argus II system; * Subject's eye 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.

Exclusion criteria

for all subjects is the following: * Subject is unwilling or unable to travel to testing facility for at least 3 days of testing within a one-week timeframe; * Subject does not speak English; * Subject has language or hearing impairment.

Design outcomes

Primary

MeasureTime frameDescription
Duration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersUp to 7 minutes for each navigation task, on Day 1 or Day 2Participants 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.
Distance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersUp to 7 minutes for each navigation task, on Day 1 or Day 2Participants 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.
Obstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersUp to 7 minutes for each navigation task, on Day 1 or Day 2Participants 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.
Success in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended DestinationUp to 7 minutes for each navigation task, on Day 1 or Day 2Participants 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.
Accuracy of Relative Distance Judgments as Assessed by the Percentage of Correct ResponsesUp to 60 seconds for each discrimination task, on Day 1 or Day 2Participants 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).

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
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.
20
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.
6
Total26

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyArgus II system stopped functioning01
Overall StudyDied of natural causes unrelated to the study before study ended02
Overall StudyUnable or too feeble to walk independently02
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicEvaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisTotalEvaluation of Blind Participants Using the Argus II Retinal Prosthesis
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants5 Participants4 Participants
Age, Categorical
Between 18 and 65 years
19 Participants21 Participants2 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants18 Participants6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
8 Participants8 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
3 Participants3 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants0 Participants
Race (NIH/OMB)
More than one race
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants5 Participants0 Participants
Race (NIH/OMB)
White
9 Participants15 Participants6 Participants
Region of Enrollment
United States
20 Participants26 Participants6 Participants
Sex: Female, Male
Female
6 Participants8 Participants2 Participants
Sex: Female, Male
Male
14 Participants18 Participants4 Participants
Vision Impairment
Blind having Argus II Implant
0 Participants6 Participants6 Participants
Vision Impairment
Normal Vision
20 Participants20 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 202 / 6
other
Total, other adverse events
0 / 200 / 6
serious
Total, serious adverse events
0 / 200 / 6

Outcome results

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).

Time frame: Up to 60 seconds for each discrimination task, on Day 1 or Day 2

Population: Participants who completed the task are reported

ArmMeasureGroupValue (MEAN)Dispersion
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisAccuracy of Relative Distance Judgments as Assessed by the Percentage of Correct ResponsesLow Resolution / Low Field-of-View62 percentage of correct responsesStandard Error 3.4
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisAccuracy of Relative Distance Judgments as Assessed by the Percentage of Correct ResponsesLow Resolution / High Field-of-View72.2 percentage of correct responsesStandard Error 3.9
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisAccuracy of Relative Distance Judgments as Assessed by the Percentage of Correct ResponsesHigh Resolution / Low Field-of-View67.8 percentage of correct responsesStandard Error 4.4
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisAccuracy of Relative Distance Judgments as Assessed by the Percentage of Correct ResponsesHigh Resolution / High Field-of-View75.6 percentage of correct responsesStandard Error 2.9
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisAccuracy of Relative Distance Judgments as Assessed by the Percentage of Correct ResponsesHigh Resolution / High Field-of-ViewNA percentage of correct responses
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisAccuracy of Relative Distance Judgments as Assessed by the Percentage of Correct ResponsesLow Resolution / Low Field-of-View83 percentage of correct responses
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisAccuracy of Relative Distance Judgments as Assessed by the Percentage of Correct ResponsesHigh Resolution / Low Field-of-ViewNA percentage of correct responses
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisAccuracy of Relative Distance Judgments as Assessed by the Percentage of Correct ResponsesLow Resolution / High Field-of-ViewNA percentage of correct responses
Comparison: Significance of Resolution: test for null hypothesis of equivalent performance between low and high resolution vision modesp-value: 0.023ANOVA
Comparison: Significance of Resolution: test for null hypothesis of equivalent performance between low and high field-of-view vision modesp-value: 0.039ANOVA
Comparison: Significance of Interaction between Resolution and Field-of-View: test for null hypothesis of no interactionp-value: 0.801ANOVA
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.

Time frame: Up to 7 minutes for each navigation task, on Day 1 or Day 2

Population: Participants who completed the task are reported

ArmMeasureGroupValue (MEAN)Dispersion
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Haptic/Audio1.138 meters/meterStandard Error 0.035
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersObstacle Field Test: Depth Vision1.305 meters/meterStandard Error 0.027
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Depth Vision + Haptic/Audio1.130 meters/meterStandard Error 0.034
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersObstacle Field Test: Depth Vision + Haptic/Audio1.227 meters/meterStandard Error 0.018
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: High Field-of-View Depth Vision1.196 meters/meterStandard Error 0.072
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersObstacle Field Test: Haptic/Audio1.230 meters/meterStandard Error 0.026
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Depth Vision1.315 meters/meterStandard Error 0.075
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersObstacle Field Test: High Field-of-View Depth Vision1.217 meters/meterStandard Error 0.025
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersObstacle Field Test: Argus Vision1.598 meters/meterStandard Error 0.045
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Argus Vision1.236 meters/meterStandard Error 0.095
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersObstacle Field Test: Argus Vision1.543 meters/meterStandard Error 0.048
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Depth Vision1.1 meters/meter
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Depth Vision + Haptic/Audio1.505 meters/meterStandard Error 0.245
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Haptic/Audio1.735 meters/meterStandard Error 0.205
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: High Field-of-View Depth VisionNA meters/meter
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Argus VisionNA meters/meter
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersObstacle Field Test: Depth Vision1.427 meters/meterStandard Error 0.126
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersObstacle Field Test: Depth Vision + Haptic/Audio1.537 meters/meterStandard Error 0.125
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersObstacle Field Test: Haptic/Audio1.300 meters/meterStandard Error 0.095
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDistance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in MetersObstacle Field Test: High Field-of-View Depth VisionNA meters/meter
Comparison: Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modesp-value: 0.3ANOVA
Comparison: Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modesp-value: <0.001ANOVA
Comparison: Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performancep-value: <0.01t-test, 2 sided
Comparison: Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performancep-value: 0.01t-test, 2 sided
Comparison: Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performancep-value: 0.93t-test, 2 sided
Comparison: Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performancep-value: <0.01t-test, 2 sided
Comparison: 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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
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.

Time frame: Up to 7 minutes for each navigation task, on Day 1 or Day 2

Population: Participants who completed the task are reported

ArmMeasureGroupValue (MEAN)Dispersion
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersObstacle Field Test: Argus Vision14.54 seconds/meterStandard Error 1.03
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersObstacle Field Test: Depth Vision10.46 seconds/meterStandard Error 0.93
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersObstacle Field Test: Depth Vision + Haptic/Audio9.38 seconds/meterStandard Error 0.8
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersObstacle Field Test: Haptic/Audio9.72 seconds/meterStandard Error 0.83
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersObstacle Field Test: High Field-of-View Depth Vision7.54 seconds/meterStandard Error 0.68
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Argus Vision9.32 seconds/meterStandard Error 0.94
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Depth Vision8.68 seconds/meterStandard Error 0.81
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Depth Vision + Haptic/Audio7.05 seconds/meterStandard Error 0.44
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Haptic/Audio7.05 seconds/meterStandard Error 0.49
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: High Field-of-View Depth Vision6.37 seconds/meterStandard Error 0.59
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Depth Vision + Haptic/Audio7.95 seconds/meterStandard Error 1.7
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersObstacle Field Test: Argus Vision14.09 seconds/meterStandard Error 2.19
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Argus VisionNA seconds/meter
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersObstacle Field Test: Depth Vision14.60 seconds/meterStandard Error 2.17
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: High Field-of-View Depth VisionNA seconds/meter
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersObstacle Field Test: Depth Vision + Haptic/Audio14.05 seconds/meterStandard Error 1.31
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Depth Vision5.11 seconds/meter
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersObstacle Field Test: Haptic/Audio9.13 seconds/meterStandard Error 1.29
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Haptic/Audio9.31 seconds/meterStandard Error 1.75
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisDuration of Time to Complete Navigational Tasks as Assessed by the Mean Duration of Travel in Seconds Normalized by the Nominal Path Distance in MetersObstacle Field Test: High Field-of-View Depth VisionNA seconds/meter
Comparison: Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modesp-value: 0.02ANOVA
Comparison: Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performancep-value: 0.22t-test, 2 sided
Comparison: Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performancep-value: 0.017t-test, 2 sided
Comparison: Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performancep-value: 0.98t-test, 2 sided
Comparison: Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performancep-value: 0.014t-test, 2 sided
Comparison: Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modesp-value: <0.001ANOVA
Comparison: Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performancep-value: <0.01t-test, 2 sided
Comparison: Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performancep-value: 0.156t-test, 2 sided
Comparison: Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performancep-value: 0.541t-test, 2 sided
Comparison: Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performancep-value: <0.01t-test, 2 sided
Comparison: 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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
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.

Time frame: Up to 7 minutes for each navigation task, on Day 1 or Day 2

Population: Participants who completed the task are reported

ArmMeasureGroupValue (MEAN)Dispersion
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersObstacle Field Test: Argus Vision0.737 number of contacts / meterStandard Error 0.06
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersObstacle Field Test: Depth Vision0.224 number of contacts / meterStandard Error 0.039
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersObstacle Field Test: Depth Vision + Haptic/Audio0.201 number of contacts / meterStandard Error 0.025
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersObstacle Field Test: Haptic/Audio0.250 number of contacts / meterStandard Error 0.035
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersObstacle Field Test: High Field-of-View Depth Vision0.090 number of contacts / meterStandard Error 0.029
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Argus Vision0.407 number of contacts / meterStandard Error 0.057
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Depth Vision0.257 number of contacts / meterStandard Error 0.055
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Depth Vision + Haptic/Audio0.130 number of contacts / meterStandard Error 0.017
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Haptic/Audio0.151 number of contacts / meterStandard Error 0.016
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: High Field-of-View Depth Vision0.162 number of contacts / meterStandard Error 0.035
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Depth Vision + Haptic/Audio0.054 number of contacts / meterStandard Error 0.013
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersObstacle Field Test: Argus Vision0.523 number of contacts / meterStandard Error 0.101
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Argus VisionNA number of contacts / meter
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersObstacle Field Test: Depth Vision0.465 number of contacts / meterStandard Error 0.058
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: High Field-of-View Depth VisionNA number of contacts / meter
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersObstacle Field Test: Depth Vision + Haptic/Audio0.175 number of contacts / meterStandard Error 0.101
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Depth Vision0.297 number of contacts / meter
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersObstacle Field Test: Haptic/Audio0.116 number of contacts / meterStandard Error 0.116
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersNavigate to Destination Test: Haptic/Audio0.061 number of contacts / meterStandard Error 0.006
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisObstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in MetersObstacle Field Test: High Field-of-View Depth VisionNA number of contacts / meter
Comparison: Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modesp-value: <0.001ANOVA
Comparison: Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performancep-value: <0.01t-test, 2 sided
Comparison: Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performancep-value: 0.037t-test, 2 sided
Comparison: Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performancep-value: 0.34t-test, 2 sided
Comparison: Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performancep-value: 0.1t-test, 2 sided
Comparison: Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modesp-value: <0.001ANOVA
Comparison: Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performancep-value: <0.01t-test, 2 sided
Comparison: Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performancep-value: 0.67t-test, 2 sided
Comparison: Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performancep-value: 0.23t-test, 2 sided
Comparison: Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performancep-value: <0.01t-test, 2 sided
Comparison: 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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
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.

Time frame: Up to 7 minutes for each navigation task, on Day 1 or Day 2

Population: Participants who completed the task are reported

ArmMeasureGroupValue (MEAN)Dispersion
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisSuccess in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended DestinationDepth Vision65.7 percentage of trialsStandard Error 8.6
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisSuccess in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended DestinationHaptic / Audio92.5 percentage of trialsStandard Error 4.1
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisSuccess in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended DestinationDepth Vision + Haptic / Audio97.5 percentage of trialsStandard Error 2.5
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisSuccess in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended DestinationHigh Field of View Depth Vision72.5 percentage of trialsStandard Error 7.7
Evaluation of Normally Sighted Participants Using a Simulated Visual ProsthesisSuccess in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended DestinationArgus Vision50.0 percentage of trialsStandard Error 8.9
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisSuccess in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended DestinationHigh Field of View Depth Vision100 percentage of trials
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisSuccess in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended DestinationArgus Vision0 percentage of trials
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisSuccess in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended DestinationDepth Vision50 percentage of trials
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisSuccess in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended DestinationDepth Vision + Haptic / Audio100 percentage of trials
Evaluation of Blind Participants Using the Argus II Retinal ProsthesisSuccess in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended DestinationHaptic / Audio100 percentage of trials
Comparison: Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modesp-value: <0.001ANOVA
Comparison: Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performancep-value: 0.17t-test, 2 sided
Comparison: Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performancep-value: <0.01t-test, 2 sided
Comparison: Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performancep-value: 0.33t-test, 2 sided
Comparison: Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performancep-value: <0.01t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026