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Object Finder for a Retinal Prosthesis

Primary Purpose

Retinitis Pigmentosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Object recognition subsystem
Sponsored by
Minnesota HealthSolutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Retinitis Pigmentosa focused on measuring retinitis pigmentosa, Argus II retinal prosthesis system

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device feasibility

Arm Description

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.

Outcomes

Primary Outcome Measures

Performance (% correct)
This outcome measure will compare task completion without and with use of the subsystem
Performance (% correct)
This outcome measure will compare task completion without and with use of the subsystem
Time to completion
This outcome measure will compare task completion without and with use of the subsystem
Time to completion
This outcome measure will compare task completion without and with use of the subsystem

Secondary Outcome Measures

Full Information

First Posted
March 16, 2020
Last Updated
September 14, 2022
Sponsor
Minnesota HealthSolutions
Collaborators
Johns Hopkins University, Second Sight Medical Products
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1. Study Identification

Unique Protocol Identification Number
NCT04319809
Brief Title
Object Finder for a Retinal Prosthesis
Official Title
Object Finder for a Retinal Prosthesis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minnesota HealthSolutions
Collaborators
Johns Hopkins University, Second Sight Medical Products

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa
Keywords
retinitis pigmentosa, Argus II retinal prosthesis system

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a small sample open label feasibility study for an object recognition and localization system based on machine learning
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device feasibility
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Object recognition subsystem
Intervention Description
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.
Primary Outcome Measure Information:
Title
Performance (% correct)
Description
This outcome measure will compare task completion without and with use of the subsystem
Time Frame
Year 1 (prototype)
Title
Performance (% correct)
Description
This outcome measure will compare task completion without and with use of the subsystem
Time Frame
Year 3 (pre-production unit)
Title
Time to completion
Description
This outcome measure will compare task completion without and with use of the subsystem
Time Frame
Year 1 (prototype)
Title
Time to completion
Description
This outcome measure will compare task completion without and with use of the subsystem
Time Frame
Year 3 (pre-production unit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gislin Dagnelie, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be available from the investigative team, following initial publication of the results
IPD Sharing Time Frame
Spring 2022 onward
IPD Sharing Access Criteria
Any researchers wit ha legitimate reason for wishing to re-analyze the data or compare them to study data collected in similar experiments

Learn more about this trial

Object Finder for a Retinal Prosthesis

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