Trial Outcomes & Findings for Object Finder for a Retinal Prosthesis (NCT NCT04319809)
NCT ID: NCT04319809
Last Updated: 2024-10-15
Results Overview
This outcome measure compares time to task completion without and with modalities of the subsystem for both a stationary and mobility task. For the stationary task, participants were seated in front of a table and a cell phone was placed randomly at the center of one of ten rectangular zones. Participants were asked to find and put their hand on the location of the cell phone. The time of the response was recorded (and the distance from the cell phone, which is a separate primary outcome). For the mobility task, participants were asked to find a target person in an otherwise empty room with dark walls. Once the participant got within arm's length, the target person would initiate a handshake. The time and number of steps (a separate primary outcome) were recorded. If the person wasn't found within 5 minutes, the task was stopped and scored as incomplete.
COMPLETED
NA
9 participants
Time in seconds to complete task. Stationary task time was time to placing hand on the table with the cell phone and mobility task time was time to handshake with the target person.
2024-10-15
Participant Flow
Participant milestones
| Measure |
Argus II Users
Blind individuals previously implanted with the Argus II retinal prosthesis system were invited to join the study. Data were collected in 4 participants ranging in age from 61 to 90 years old. One participant was female, all identified as white, non-hispanic.
|
Legally Blind Individuals
Individuals with profound visual impairment (best corrected visual acuity worse than 20/500) were invited to join the study. Data were collected in 5 participants ranging in age from 31 to 54 years old. One participant was female, all identified as white, non-hispanic.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Object Finder for a Retinal Prosthesis
Baseline characteristics by cohort
| Measure |
Argus II Users
n=4 Participants
Blind individuals previously implanted with the Argus II retinal prosthesis system were invited to join the study. Data were collected in 4 participants ranging in age from 61 to 90 years old. One participant was female, all identified as white, non-hispanic.
|
Legally Blind Individuals
n=5 Participants
Individuals with profound visual impairment (best corrected visual acuity worse than 20/500) were invited to join the study. Data were collected in 5 participants ranging in age from 31 to 54 years old. One participant was female, all identified as white, non-hispanic.
|
Total
n=9 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
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
77 years
n=5 Participants
|
35 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 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
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time in seconds to complete task. Stationary task time was time to placing hand on the table with the cell phone and mobility task time was time to handshake with the target person.Population: Blind individuals previously implanted with the Argus II retinal prosthesis system were invited to join the study. Data were collected in 4 participants. Individuals with profound visual impairment (best corrected visual acuity worse than 20/500) were invited to join the study. Data were collected in 5 participants.
This outcome measure compares time to task completion without and with modalities of the subsystem for both a stationary and mobility task. For the stationary task, participants were seated in front of a table and a cell phone was placed randomly at the center of one of ten rectangular zones. Participants were asked to find and put their hand on the location of the cell phone. The time of the response was recorded (and the distance from the cell phone, which is a separate primary outcome). For the mobility task, participants were asked to find a target person in an otherwise empty room with dark walls. Once the participant got within arm's length, the target person would initiate a handshake. The time and number of steps (a separate primary outcome) were recorded. If the person wasn't found within 5 minutes, the task was stopped and scored as incomplete.
Outcome measures
| Measure |
Argus II Users
n=4 Participants
To investigate the utility of a device adaptation allowing Argus II users to detect the presence and location of desired objects. Performance of the unaided Argus II system will be compared with performance using the system augmented with object recognition. Performance will be compared for Argus II Users and Legally Blind Individuals.
Object recognition subsystem: The object recognition subsystem is an add-on to the Argus II retinal prosthesis system. in the early stage of the study the subsystem will run on a separate processor; in the later stage the subsystem will run in the Argus II user's video processing unit.
|
Legally Blind Individuals
n=5 Participants
To investigate the utility of a device adaptation allowing Legally Blind Individuals to detect the presence and location of desired objects. Performance of the object finder system will be compared with performance using the system augmented with object recognition. Performance will be compared for Argus II Users and Legally Blind Individuals.
|
|---|---|---|
|
Performance (Completion Time) Locating a Cell Phone and a Person
Stationary, Normal Camera
|
47 time (s)
Standard Deviation 16.6
|
11 time (s)
Standard Deviation 13.5
|
|
Performance (Completion Time) Locating a Cell Phone and a Person
Stationary, Icon
|
30 time (s)
Standard Deviation 6.1
|
23 time (s)
Standard Deviation 9.7
|
|
Performance (Completion Time) Locating a Cell Phone and a Person
Stationary, Tone
|
26 time (s)
Standard Deviation 6.6
|
21 time (s)
Standard Deviation 10.4
|
|
Performance (Completion Time) Locating a Cell Phone and a Person
Stationary, Speech
|
19 time (s)
Standard Deviation 4.7
|
26 time (s)
Standard Deviation 18.1
|
|
Performance (Completion Time) Locating a Cell Phone and a Person
Stationary, Normal Camera plus Tone
|
24 time (s)
Standard Deviation 1.7
|
16 time (s)
Standard Deviation 17.3
|
|
Performance (Completion Time) Locating a Cell Phone and a Person
Stationary, Normal Camera plus Speech
|
27 time (s)
Standard Deviation 5.6
|
12 time (s)
Standard Deviation 9.4
|
|
Performance (Completion Time) Locating a Cell Phone and a Person
Stationary, Tone plus Icon
|
27 time (s)
Standard Deviation 2.9
|
22 time (s)
Standard Deviation 10.7
|
|
Performance (Completion Time) Locating a Cell Phone and a Person
Stationary, Speech plus Icon
|
27 time (s)
Standard Deviation 5.1
|
35 time (s)
Standard Deviation 33.1
|
|
Performance (Completion Time) Locating a Cell Phone and a Person
Stationary, Tactile
|
6 time (s)
Standard Deviation 2.0
|
6 time (s)
Standard Deviation 2.0
|
|
Performance (Completion Time) Locating a Cell Phone and a Person
Mobility, Normal Camera
|
135 time (s)
Standard Deviation 3.7
|
9 time (s)
Standard Deviation 15.6
|
|
Performance (Completion Time) Locating a Cell Phone and a Person
Mobility, Icon
|
37 time (s)
Standard Deviation 10.2
|
44 time (s)
Standard Deviation 86.1
|
|
Performance (Completion Time) Locating a Cell Phone and a Person
Mobility, Tone
|
35 time (s)
Standard Deviation .9
|
17 time (s)
Standard Deviation 4.3
|
|
Performance (Completion Time) Locating a Cell Phone and a Person
Mobility, Speech
|
28 time (s)
Standard Deviation 6.6
|
15 time (s)
Standard Deviation 1.9
|
|
Performance (Completion Time) Locating a Cell Phone and a Person
Mobility, Normal Camera plus Tone
|
29 time (s)
Standard Deviation 9.1
|
6 time (s)
Standard Deviation 6.4
|
|
Performance (Completion Time) Locating a Cell Phone and a Person
Mobility, Normal Camera plus Speech
|
27 time (s)
Standard Deviation 11.4
|
9 time (s)
Standard Deviation 9.1
|
|
Performance (Completion Time) Locating a Cell Phone and a Person
Tone plus Icon
|
36 time (s)
Standard Deviation 1.6
|
8 time (s)
Standard Deviation 4.9
|
|
Performance (Completion Time) Locating a Cell Phone and a Person
Speech plus Icon
|
38 time (s)
Standard Deviation 10.5
|
12 time (s)
Standard Deviation 8.8
|
PRIMARY outcome
Timeframe: Distance to cell phone required up to 30 minutes per mode and distance to a person required up to 45 minutes per mode.Population: Blind individuals previously implanted with the Argus II retinal prosthesis system were invited to join the study. Data were collected in 4 participants. Individuals with profound visual impairment (best corrected visual acuity worse than 20/500) were invited to join the study. Data were collected in 5 participants.
This outcome measure compares task completion (accuracy to a target) without and with modalities of the subsystem for both a stationary and mobility task. For the stationary task, participants were seated in front of a table and a cell phone was placed randomly at the center of one of ten rectangular zones. Participants were asked to find and put their hand on the location of the cell phone. The distance to the cell phone in centimeters was recorded. For the mobility task, participants were asked to find a target person in an otherwise empty room with dark walls. Once the participant got within arm's length, the target person would initiate a handshake. The number of steps were recorded. If the person wasn't found within 5 minutes, the task was stopped and scored as incomplete.
Outcome measures
| Measure |
Argus II Users
n=4 Participants
To investigate the utility of a device adaptation allowing Argus II users to detect the presence and location of desired objects. Performance of the unaided Argus II system will be compared with performance using the system augmented with object recognition. Performance will be compared for Argus II Users and Legally Blind Individuals.
Object recognition subsystem: The object recognition subsystem is an add-on to the Argus II retinal prosthesis system. in the early stage of the study the subsystem will run on a separate processor; in the later stage the subsystem will run in the Argus II user's video processing unit.
|
Legally Blind Individuals
n=5 Participants
To investigate the utility of a device adaptation allowing Legally Blind Individuals to detect the presence and location of desired objects. Performance of the object finder system will be compared with performance using the system augmented with object recognition. Performance will be compared for Argus II Users and Legally Blind Individuals.
|
|---|---|---|
|
Accuracy (Distance From Target)
Mobility, Icon
|
17 cm
Standard Deviation 7.3
|
8 cm
Standard Deviation 7.5
|
|
Accuracy (Distance From Target)
Mobility, Tone
|
21 cm
Standard Deviation 8.8
|
8 cm
Standard Deviation 1.6
|
|
Accuracy (Distance From Target)
Mobility, Speech
|
17 cm
Standard Deviation 7.6
|
8 cm
Standard Deviation 1.7
|
|
Accuracy (Distance From Target)
Mobility, Normal Camera plus Tone
|
18 cm
Standard Deviation 8.9
|
4 cm
Standard Deviation 4.0
|
|
Accuracy (Distance From Target)
Mobility, Normal Camera plus Speech
|
16 cm
Standard Deviation 7.0
|
5 cm
Standard Deviation 4.5
|
|
Accuracy (Distance From Target)
Mobility, Tone plus Icon
|
17 cm
Standard Deviation 7.8
|
6 cm
Standard Deviation 3.5
|
|
Accuracy (Distance From Target)
Mobility, Speech plus Icon
|
17 cm
Standard Deviation 5.0
|
6 cm
Standard Deviation 3.6
|
|
Accuracy (Distance From Target)
Stationary, Normal Camera
|
7 cm
Standard Deviation 6.6
|
4 cm
Standard Deviation 7.0
|
|
Accuracy (Distance From Target)
Stationary, Icon
|
3 cm
Standard Deviation 1.8
|
4 cm
Standard Deviation 6.1
|
|
Accuracy (Distance From Target)
Stationary, Tone
|
1 cm
Standard Deviation .8
|
3 cm
Standard Deviation 1.5
|
|
Accuracy (Distance From Target)
Stationary, Speech
|
2 cm
Standard Deviation .7
|
2 cm
Standard Deviation .9
|
|
Accuracy (Distance From Target)
Stationary, Normal Camera plus Tone
|
3 cm
Standard Deviation .5
|
1 cm
Standard Deviation 2.4
|
|
Accuracy (Distance From Target)
Stationary, Normal Camera plus Speech
|
3. cm
Standard Deviation 1.6
|
1 cm
Standard Deviation 1.8
|
|
Accuracy (Distance From Target)
Stationary, Tone plus Icon
|
1 cm
Standard Deviation 1.0
|
1 cm
Standard Deviation .9
|
|
Accuracy (Distance From Target)
Stationary, Speech plus Icon
|
2 cm
Standard Deviation 1.4
|
2 cm
Standard Deviation 1.4
|
|
Accuracy (Distance From Target)
Stationary, Tactile
|
0 cm
Standard Deviation 0
|
0 cm
Standard Deviation 0
|
|
Accuracy (Distance From Target)
Mobility, Normal Camera
|
52 cm
Standard Deviation 23.0
|
4 cm
Standard Deviation 4
|
Adverse Events
Argus II Users
Legally Blind Individuals
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