Clinical trial NCT04319809: Object Finder for a Retinal Prosthesis
Official title: Object Finder for a Retinal Prosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Keywords: retinitis pigmentosa
Argus II retinal prosthesis system
Lead sponsor: Minnesota HealthSolutions
Sponsor class: INDUSTRY
Collaborators: name: Johns Hopkins University
name: Second Sight Medical Products
First posted: 2020-03-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a small sample open label feasibility study for an object recognition and localization system based on machine learning
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Performance (Completion Time) Locating a Cell Phone and a Person
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.
measure: Accuracy (Distance From Target)
timeFrame: Distance to cell phone required up to 30 minutes per mode and distance to a person required up to 45 minutes per mode.
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Gislin Dagnelie, PhD
role: PRINCIPAL_INVESTIGATOR
References: