- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04319809
Object Finder for a Retinal Prosthesis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- For healthy volunteers: Vision corrected to 20/25, good general health
- For retinitis pigmentosa (RP) patients: End-stage retinitis pigmentosa, recipient of an Argus II retinal prosthesis system
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Device feasibility
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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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance (% correct)
Time Frame: Year 1 (prototype)
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This outcome measure will compare task completion without and with use of the subsystem
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Year 1 (prototype)
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Performance (% correct)
Time Frame: Year 3 (pre-production unit)
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This outcome measure will compare task completion without and with use of the subsystem
|
Year 3 (pre-production unit)
|
Time to completion
Time Frame: Year 1 (prototype)
|
This outcome measure will compare task completion without and with use of the subsystem
|
Year 1 (prototype)
|
Time to completion
Time Frame: Year 3 (pre-production unit)
|
This outcome measure will compare task completion without and with use of the subsystem
|
Year 3 (pre-production unit)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gislin Dagnelie, PhD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MHS-OF01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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