Object Finder for a Retinal Prosthesis

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.

Study Overview

• Status: Completed
• Conditions: Retinitis Pigmentosa
• Intervention / Treatment: Device: Object recognition subsystem

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: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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)

Number of Arms

1

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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Minnesota HealthSolutions
• Collaborators: Johns Hopkins University; Second Sight Medical Products
• Investigators: Principal Investigator: Gislin Dagnelie, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: retinitis pigmentosa; Argus II retinal prosthesis system
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinitis; Retinitis Pigmentosa
• Other Study ID Numbers: MHS-OF01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• 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