Trial Outcomes & Findings for Environmental Localization Mapping and Guidance for Visual Prosthesis Users (NCT NCT04359108)
NCT ID: NCT04359108
Last Updated: 2025-03-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Up to 7 minutes for each navigation task, on Day 1 or Day 2
Results posted on
2025-03-10
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
6
|
|
Overall Study
COMPLETED
|
19
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Unable or too feeble to walk independently
|
0
|
2
|
|
Overall Study
Argus II system stopped functioning
|
0
|
1
|
|
Overall Study
Died of natural causes unrelated to the study before study ended
|
0
|
2
|
Baseline Characteristics
Environmental Localization Mapping and Guidance for Visual Prosthesis Users
Baseline characteristics by cohort
| Measure |
Evaluation of Normally Sighted Participants Using a Simulated Visual Prosthesis
n=20 Participants
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.
|
Evaluation of Blind Participants Using the Argus II Retinal Prosthesis
n=6 Participants
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.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Vision Impairment
Normal Vision
|
20 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Vision Impairment
Blind having Argus II Implant
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 7 minutes for each navigation task, on Day 1 or Day 2Population: Participants who completed the task are reported
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.
Outcome measures
| Measure |
Evaluation of Normally Sighted Participants Using a Simulated Visual Prosthesis
n=20 Participants
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.
|
Evaluation of Blind Participants Using the Argus II Retinal Prosthesis
n=1 Participants
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.
|
|---|---|---|
|
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
Obstacle Field Test: Depth Vision + Haptic/Audio
|
9.38 seconds/meter
Standard Error 0.80
|
14.05 seconds/meter
Standard Error 1.31
|
|
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
Obstacle Field Test: High Field-of-View Depth Vision
|
7.54 seconds/meter
Standard Error 0.68
|
NA seconds/meter
Standard Error NA
Prosthetic implant for Argus II users does not support wide field-of-view vision of this intervention.
|
|
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
Navigate to Destination Test: Argus Vision
|
9.32 seconds/meter
Standard Error 0.94
|
NA seconds/meter
Standard Error NA
Intended destination was not successfully reached in any trials for this task and intervention, therefore statistics cannot be computed.
|
|
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
Obstacle Field Test: Argus Vision
|
14.54 seconds/meter
Standard Error 1.03
|
14.09 seconds/meter
Standard Error 2.19
|
|
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
Obstacle Field Test: Depth Vision
|
10.46 seconds/meter
Standard Error 0.93
|
14.60 seconds/meter
Standard Error 2.17
|
|
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
Navigate to Destination Test: Depth Vision
|
8.68 seconds/meter
Standard Error 0.81
|
5.11 seconds/meter
Standard Error NA
Intended destination was successfully reached in only 1 trial for this task and intervention, therefore standard error cannot be computed.
|
|
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
Navigate to Destination Test: Depth Vision + Haptic/Audio
|
7.05 seconds/meter
Standard Error 0.44
|
7.95 seconds/meter
Standard Error 1.70
|
|
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
Navigate to Destination Test: Haptic/Audio
|
7.05 seconds/meter
Standard Error 0.49
|
9.31 seconds/meter
Standard Error 1.75
|
|
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
Obstacle Field Test: Haptic/Audio
|
9.72 seconds/meter
Standard Error 0.83
|
9.13 seconds/meter
Standard Error 1.29
|
|
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
Navigate to Destination Test: High Field-of-View Depth Vision
|
6.37 seconds/meter
Standard Error 0.59
|
NA seconds/meter
Standard Error NA
Prosthetic implant for Argus II users does not support wide field-of-view vision of this intervention.
|
PRIMARY outcome
Timeframe: Up to 7 minutes for each navigation task, on Day 1 or Day 2Population: Participants who completed the task are reported
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.
Outcome measures
| Measure |
Evaluation of Normally Sighted Participants Using a Simulated Visual Prosthesis
n=20 Participants
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.
|
Evaluation of Blind Participants Using the Argus II Retinal Prosthesis
n=1 Participants
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.
|
|---|---|---|
|
Distance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in Meters
Obstacle Field Test: High Field-of-View Depth Vision
|
1.217 meters/meter
Standard Error 0.025
|
NA meters/meter
Standard Error NA
Prosthetic implant for Argus II users does not support wide field-of-view vision of this intervention.
|
|
Distance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in Meters
Navigate to Destination Test: Haptic/Audio
|
1.138 meters/meter
Standard Error 0.035
|
1.735 meters/meter
Standard Error 0.205
|
|
Distance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in Meters
Obstacle Field Test: Argus Vision
|
1.598 meters/meter
Standard Error 0.045
|
1.543 meters/meter
Standard Error 0.048
|
|
Distance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in Meters
Obstacle Field Test: Depth Vision
|
1.305 meters/meter
Standard Error 0.027
|
1.427 meters/meter
Standard Error 0.126
|
|
Distance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in Meters
Obstacle Field Test: Depth Vision + Haptic/Audio
|
1.227 meters/meter
Standard Error 0.018
|
1.537 meters/meter
Standard Error 0.125
|
|
Distance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in Meters
Obstacle Field Test: Haptic/Audio
|
1.230 meters/meter
Standard Error 0.026
|
1.300 meters/meter
Standard Error 0.095
|
|
Distance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in Meters
Navigate to Destination Test: Argus Vision
|
1.236 meters/meter
Standard Error 0.095
|
NA meters/meter
Standard Error NA
Intended destination was not successfully reached in any trial for this task and intervention, therefore statistics cannot be computed.
|
|
Distance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in Meters
Navigate to Destination Test: Depth Vision
|
1.315 meters/meter
Standard Error 0.075
|
1.1 meters/meter
Standard Error NA
Intended destination was successfully reached in only 1 trials for this task and intervention, therefore standard error cannot be computed.
|
|
Distance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in Meters
Navigate to Destination Test: Depth Vision + Haptic/Audio
|
1.130 meters/meter
Standard Error 0.034
|
1.505 meters/meter
Standard Error 0.245
|
|
Distance Traversed to Complete Navigational Tasks as Assessed by the Mean Distance Traveled in Meters Normalized by the Nominal Path Distance in Meters
Navigate to Destination Test: High Field-of-View Depth Vision
|
1.196 meters/meter
Standard Error 0.072
|
NA meters/meter
Standard Error NA
Prosthetic implant for Argus II users does not support wide field-of-view vision of this intervention.
|
PRIMARY outcome
Timeframe: Up to 7 minutes for each navigation task, on Day 1 or Day 2Population: Participants who completed the task are reported
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.
Outcome measures
| Measure |
Evaluation of Normally Sighted Participants Using a Simulated Visual Prosthesis
n=20 Participants
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.
|
Evaluation of Blind Participants Using the Argus II Retinal Prosthesis
n=1 Participants
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.
|
|---|---|---|
|
Obstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in Meters
Obstacle Field Test: Argus Vision
|
0.737 number of contacts / meter
Standard Error 0.060
|
0.523 number of contacts / meter
Standard Error 0.101
|
|
Obstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in Meters
Obstacle Field Test: Depth Vision
|
0.224 number of contacts / meter
Standard Error 0.039
|
0.465 number of contacts / meter
Standard Error 0.058
|
|
Obstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in Meters
Obstacle Field Test: Depth Vision + Haptic/Audio
|
0.201 number of contacts / meter
Standard Error 0.025
|
0.175 number of contacts / meter
Standard Error 0.101
|
|
Obstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in Meters
Obstacle Field Test: High Field-of-View Depth Vision
|
0.090 number of contacts / meter
Standard Error 0.029
|
NA number of contacts / meter
Standard Error NA
Prosthetic implant for Argus II users does not support wide field-of-view vision of this intervention.
|
|
Obstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in Meters
Navigate to Destination Test: Argus Vision
|
0.407 number of contacts / meter
Standard Error 0.057
|
NA number of contacts / meter
Standard Error NA
Intended destination was not successfully reached in any trials for this task and intervention, therefore statistics cannot be computed.
|
|
Obstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in Meters
Navigate to Destination Test: Depth Vision
|
0.257 number of contacts / meter
Standard Error 0.055
|
0.297 number of contacts / meter
Standard Error NA
Intended destination was successfully reached in only 1 trial for this task and intervention, therefore standard error cannot be computed.
|
|
Obstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in Meters
Obstacle Field Test: Haptic/Audio
|
0.250 number of contacts / meter
Standard Error 0.035
|
0.116 number of contacts / meter
Standard Error 0.116
|
|
Obstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in Meters
Navigate to Destination Test: High Field-of-View Depth Vision
|
0.162 number of contacts / meter
Standard Error 0.035
|
NA number of contacts / meter
Standard Error NA
Prosthetic implant for Argus II users does not support wide field-of-view vision of this intervention.
|
|
Obstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in Meters
Navigate to Destination Test: Depth Vision + Haptic/Audio
|
0.130 number of contacts / meter
Standard Error 0.017
|
0.054 number of contacts / meter
Standard Error 0.013
|
|
Obstacle Avoidance While Completing Navigational Tasks as Assessed by the Mean Number of Contacts With Obstacles Normalized by the Nominal Path Distance in Meters
Navigate to Destination Test: Haptic/Audio
|
0.151 number of contacts / meter
Standard Error 0.016
|
0.061 number of contacts / meter
Standard Error 0.006
|
PRIMARY outcome
Timeframe: Up to 7 minutes for each navigation task, on Day 1 or Day 2Population: Participants who completed the task are reported
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.
Outcome measures
| Measure |
Evaluation of Normally Sighted Participants Using a Simulated Visual Prosthesis
n=20 Participants
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.
|
Evaluation of Blind Participants Using the Argus II Retinal Prosthesis
n=1 Participants
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.
|
|---|---|---|
|
Success in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended Destination
Argus Vision
|
50.0 percentage of trials
Standard Error 8.9
|
0 percentage of trials
Standard Error NA
Standard error cannot be measured due to having only 1 measured value from 1 participant.
|
|
Success in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended Destination
Depth Vision
|
65.7 percentage of trials
Standard Error 8.6
|
50 percentage of trials
Standard Error NA
Standard error cannot be measured due to having only 1 measured value from 1 participant.
|
|
Success in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended Destination
Depth Vision + Haptic / Audio
|
97.5 percentage of trials
Standard Error 2.5
|
100 percentage of trials
Standard Error NA
Standard error cannot be measured due to having only 1 measured value from 1 participant.
|
|
Success in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended Destination
Haptic / Audio
|
92.5 percentage of trials
Standard Error 4.1
|
100 percentage of trials
Standard Error NA
Standard error cannot be measured due to having only 1 measured value from 1 participant.
|
|
Success in Completing Navigational Tasks as Assessed by the Mean Percentage of Trials Where Participants Successfully Reached the Intended Destination
High Field of View Depth Vision
|
72.5 percentage of trials
Standard Error 7.7
|
100 percentage of trials
Standard Error NA
Standard error cannot be measured due to having only 1 measured value from 1 participant.
|
PRIMARY outcome
Timeframe: Up to 60 seconds for each discrimination task, on Day 1 or Day 2Population: Participants who completed the task are reported
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).
Outcome measures
| Measure |
Evaluation of Normally Sighted Participants Using a Simulated Visual Prosthesis
n=10 Participants
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.
|
Evaluation of Blind Participants Using the Argus II Retinal Prosthesis
n=1 Participants
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.
|
|---|---|---|
|
Accuracy of Relative Distance Judgments as Assessed by the Percentage of Correct Responses
Low Resolution / Low Field-of-View
|
62 percentage of correct responses
Standard Error 3.4
|
83 percentage of correct responses
Standard Error NA
Standard error cannot be measured due to having only 1 measured value from 1 participant.
|
|
Accuracy of Relative Distance Judgments as Assessed by the Percentage of Correct Responses
Low Resolution / High Field-of-View
|
72.2 percentage of correct responses
Standard Error 3.9
|
NA percentage of correct responses
Standard Error NA
Prosthetic implant for Argus II users does not support the high field-of-view vision of this mode.
|
|
Accuracy of Relative Distance Judgments as Assessed by the Percentage of Correct Responses
High Resolution / Low Field-of-View
|
67.8 percentage of correct responses
Standard Error 4.4
|
NA percentage of correct responses
Standard Error NA
Prosthetic implant for Argus II users does not support the high resolution vision of this mode.
|
|
Accuracy of Relative Distance Judgments as Assessed by the Percentage of Correct Responses
High Resolution / High Field-of-View
|
75.6 percentage of correct responses
Standard Error 2.9
|
NA percentage of correct responses
Standard Error NA
Prosthetic implant for Argus II users does not support the high resolution and high field-of-view vision of this mode.
|
Adverse Events
Evaluation of Normally Sighted Participants Using a Simulated Visual Prosthesis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Evaluation of Blind Participants Using the Argus II Retinal Prosthesis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place