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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Second Sight Medical Products | INDUSTRY |
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The proposed project seeks to provide object recognition as a feature in a retinal implant system. Participants will be able to direct an object recognition application to find a desired object in the field of view of the head-mounted camera, and to direct the participant's view towards it through the presentation of a recognizable icon. A prototype system will be developed and evaluated in human subjects in phase I. A full system implementation and a second phase of the trial will be completed in phase II.
The investigators propose to add an object-finding feature to a retinal prosthesis system. To use this feature, the participant will enable a special mode and input the desired object from a set of pre-programmed object types. Imagery from the visible light camera in the system eyeglasses will be processed using object recognition software as the participant scans their head across the room scene. When the object is identified in the scene by the processor, a flashing icon will be output to the epiretinal array in the appropriate position to guide the participant to the physical location of the object. Once located, the system will track the location of the object.
There will be two phases to the human subjects evaluation, each run initially through simulations in sighted human subjects, followed by tests in Argus II participants. In phase 1, system evaluation in human subjects at Johns Hopkins UNiversity (JHU) will explore performance in representative tasks and compare prosthetic visual performance without and with the new object finding feature. An important aspect of the evaluation will be the comparison of different icons and presentation modes to assist participants in locating and reaching objects. In phase 2, the system will be integrated into the Argus II video processing unit (VPU), and JHU will conduct human trials that include functional testing of the integrated prototype in representative environments and optimizing the ergonomics of the system, e.g. simultaneous finding and tracking of multiple objects/icons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device feasibility | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Object recognition subsystem | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance (Completion Time) Locating a Cell Phone and a Person | 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. | 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. |
| Accuracy (Distance From Target) | 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. | Distance to cell phone required up to 30 minutes per mode and distance to a person required up to 45 minutes per mode. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gislin Dagnelie, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
Deidentified data will be available from the investigative team, following initial publication of the results
Spring 2022 onward
Any researchers wit ha legitimate reason for wishing to re-analyze the data or compare them to study data collected in similar experiments
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| ID | Title | Description |
|---|---|---|
| FG000 | Argus II Users | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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See enrollment group descriptions
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Legally Blind Individuals |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Performance (Completion Time) Locating a Cell Phone and a Person | 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. | 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. | Posted | Mean | Standard Deviation | time (s) | 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. |
3 years
Verbal reports were collected at the start of each test session, and any events occurring during the session were recorded
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Argus II Users | Blind individuals previously implanted with the Argus II retinal prosthesis system were invited to join the study. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Seifert, President | Minnesota HealthSolutions | 6128036998 | sara@minnhealth.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 26, 2018 | Oct 7, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 13, 2021 | Nov 27, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
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This is a small sample open label feasibility study for an object recognition and localization system based on machine learning
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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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Accuracy (Distance From Target) | 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. | 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. | Posted | Mean | Standard Deviation | cm | Distance to cell phone required up to 30 minutes per mode and distance to a person required up to 45 minutes per mode. |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Stationary, Tone |
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| Stationary, Speech |
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| Stationary, Normal Camera plus Tone |
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| Stationary, Normal Camera plus Speech |
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| Stationary, Tone plus Icon |
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| Stationary, Speech plus Icon |
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| Stationary, Tactile |
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| Mobility, Normal Camera |
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| Mobility, Icon |
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| Mobility, Tone |
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| Mobility, Speech |
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| Mobility, Normal Camera plus Tone |
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| Mobility, Normal Camera plus Speech |
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| Mobility, Tone plus Icon |
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| Mobility, Speech plus Icon |
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