Object Finder for a Retinal Prosthesis

Sponsor
Minnesota HealthSolutions (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04319809
Collaborator
Johns Hopkins University (Other), Second Sight Medical Products (Industry)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Object recognition subsystem
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a small sample open label feasibility study for an object recognition and localization system based on machine learningThis is a small sample open label feasibility study for an object recognition and localization system based on machine learning
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Object Finder for a Retinal Prosthesis
Actual Study Start Date :
Jul 1, 2017
Anticipated Primary Completion Date :
Feb 28, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

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.

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. Performance (% correct) [Year 1 (prototype)]

    This outcome measure will compare task completion without and with use of the subsystem

  2. Performance (% correct) [Year 3 (pre-producton unit)]

    This outcome measure will compare task completion without and with use of the subsystem

  3. Time to completion [Year 1 (prototype)]

    This outcome measure will compare task completion without and with use of the subsystem

  4. Time to completion [Year 3 (pre-producton unit)]

    This outcome measure will compare task completion without and with use of the subsystem

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Hospital Baltimore Maryland United States 21287

Sponsors and Collaborators

  • Minnesota HealthSolutions
  • Johns Hopkins University
  • Second Sight Medical Products

Investigators

  • Principal Investigator: Gislin Dagnelie, PhD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Minnesota HealthSolutions
ClinicalTrials.gov Identifier:
NCT04319809
Other Study ID Numbers:
  • MHS-OF01
First Posted:
Mar 24, 2020
Last Update Posted:
Sep 24, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Keywords provided by Minnesota HealthSolutions
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 24, 2021