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Environmental Localization Mapping and Guidance for Visual Prosthesis Users (SLAM)

Primary Purpose

Retinitis Pigmentosa, Visual Impairment, Visual Prosthesis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Navigation System for Users of a Visual Prosthesis
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Retinitis Pigmentosa focused on measuring Retinal Prosthesis, Argus II

Eligibility Criteria

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

Criteria for inclusion of normally sighted individuals:

  • Subject speaks English;
  • Subjects must be an adult (at least 18 years of age);
  • Subject has the cognitive and communication ability to participate in the study (i.e., follow spoken directions, perform tests, and give feedback);
  • Subject is willing to conduct psychophysics testing up to 4-6 hours per day of testing on 3-5 consecutive days;
  • Subject has visual acuity of 20/40 or better (corrected);
  • Subject is capable of understanding participant information materials and giving written informed consent.
  • Subject is able to walk unassisted

Criteria for inclusion of Argus II users:

The inclusion criteria for the study are the following:

  • Subject is at least 25 years of age;
  • Subject has been implanted with the Argus II system;
  • Subject's eye has healed from surgery and the surgeon has cleared the subject for programming;
  • Subject has the cognitive and communication ability to participate in the study (i.e., follow spoken directions, perform tests, and give feedback);
  • Subject is willing to conduct psychophysics testing up to 4-6 hours per day of testing on 3-5 consecutive days;
  • Subject is capable of understanding patient information materials and giving written informed consent;
  • Subject is able to walk unassisted.

Exclusion criteria for all subjects is the following:

  • Subject is unwilling or unable to travel to testing facility for at least 3 days of testing within a one-week timeframe;
  • Subject does not speak English;
  • Subject has language or hearing impairment.

Sites / Locations

  • Johns Hopkins Medicine - Wilmer Eye InstituteRecruiting
  • Johns Hopkins Applied Physics LaboratoryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Navigation system for users of a visual prosthesis

Arm Description

This intervention will assess the feasibility of using a navigation system to aid blind users of a visual prosthesis with navigation tasks, by using the navigation system to provide navigational cues through multiple sensory modalities including vision and audition. The navigation system will be designed and developed as part of the proposed research and will interface with the Argus II retinal prosthesis system, which is an FDA approved visual prosthesis. Existing blind users of the Argus II device will be recruited for this study, and the navigation system will interface with these subjects' existing Argus II systems. Sighted subjects will also be recruited for this study, in which case the navigation system will interface with a head-mounted display (such as the Oculus Rift) worn by the sighted subjects that simulates the visual sensory information experienced by blind users of the Argus II retinal implant.

Outcomes

Primary Outcome Measures

Accuracy as assessed as ratio of target identification success to total trials
The participant will be asked to identify intended targets in a closed environment, as well as to navigate to intended targets. We will measure accuracy as the total number of successes divided by the total number of trials.
Trial Time as assessed by mean time duration to identify target
This will be assessed by the mean duration of time to identify intended target (in seconds). For successful trials, the shorter the amount of time to conduct a task, the better the performance on said task.
Success in psychophysical judgments
This will be assessed by the metric error in distance judgment, that is, the correctness of identification of judgments of target features. Measurement in meters.

Secondary Outcome Measures

Full Information

First Posted
April 21, 2020
Last Updated
June 12, 2023
Sponsor
Johns Hopkins University
Collaborators
Carnegie Mellon University, National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT04359108
Brief Title
Environmental Localization Mapping and Guidance for Visual Prosthesis Users
Acronym
SLAM
Official Title
Environmental Localization Mapping and Guidance for Visual Prosthesis Users
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Carnegie Mellon University, National Eye Institute (NEI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is driven by the hypothesis that navigation for users of retinal prosthetics can be greatly improved by incorporating Spatial Localization and Mapping (SLAM) and object recognition technology conveying environmental information via a retinal prosthesis and auditory feedback. The investigators will study how effectively the SLAM technology enables the visual prosthesis system to construct a map of the user's environment and locate the user within that map. The technology will be tested both with normally sighted individuals donning a virtual reality headset and with retinal prosthesis users (Argus II).
Detailed Description
About 1.3 million Americans aged 40 and older are legally blind, a majority because of diseases with onset later in life, such as glaucoma and age-related macular degeneration. Second Sight Medical Products (SSMP) has developed the world's first FDA approved retinal implant, Argus II, intended to restore some functional vision for people suffering from retinitis pigmentosa (RP). In this era of smart devices, generic navigation technology, such as GPS mapping apps for smartphones, can provide directions to help guide a blind user from point A to point B. However, these navigational aids do little to enable blind users to form an egocentric understanding of the surroundings, are not suited to navigation indoors, and do nothing to assist in avoiding obstacles to mobility. The Argus II, on the other hand, provides blind users with a limited visual representation of their surroundings that improves users' ability to orient themselves and traverse obstacles, yet lacks features for high-level navigation and semantic interpretation of the surroundings. The proposed study aims to address these limitations of the Argus II through a synergy of state-of-the-art simultaneous localization and mapping (SLAM) and object recognition technologies. This study is driven by the hypothesis that navigation for users of retinal prosthetics can be greatly improved by incorporating SLAM and object recognition technology conveying environmental information via a retinal prosthesis and auditory feedback. SLAM enables the visual prosthesis system to construct a map of the user's environment and locate the user within that map. The system then provides object location and navigational cues via appropriate sensory modalities enabling the user to mentally form an egocentric map of the environment. Investigators will develop and test a visual prosthesis system which 1) constructs a map of unfamiliar environments and localizes the user using SLAM technology 2) automatically identifies navigationally-relevant objects and landmarks using object recognition and 3) provides sensory feedback for navigation, obstacle avoidance, and object/landmark identification.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa, Visual Impairment, Visual Prosthesis
Keywords
Retinal Prosthesis, Argus II

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Navigation system for users of a visual prosthesis
Arm Type
Experimental
Arm Description
This intervention will assess the feasibility of using a navigation system to aid blind users of a visual prosthesis with navigation tasks, by using the navigation system to provide navigational cues through multiple sensory modalities including vision and audition. The navigation system will be designed and developed as part of the proposed research and will interface with the Argus II retinal prosthesis system, which is an FDA approved visual prosthesis. Existing blind users of the Argus II device will be recruited for this study, and the navigation system will interface with these subjects' existing Argus II systems. Sighted subjects will also be recruited for this study, in which case the navigation system will interface with a head-mounted display (such as the Oculus Rift) worn by the sighted subjects that simulates the visual sensory information experienced by blind users of the Argus II retinal implant.
Intervention Type
Device
Intervention Name(s)
Navigation System for Users of a Visual Prosthesis
Intervention Description
We use common psychophysical judgments such as the following: discriminating between two alternatives by saying which is present in the field of view, touching a tablet computer to indicate the apparent location of a target in the frontal plane, and looking for targets by rotating the head and pointing when one is found. We will compare user performance using the Basic system with user performance using the Augmented and Augmented + Modal systems where contextual information associated with the task is conveyed to users via enhanced visual, auditory, and haptic modalities.
Primary Outcome Measure Information:
Title
Accuracy as assessed as ratio of target identification success to total trials
Description
The participant will be asked to identify intended targets in a closed environment, as well as to navigate to intended targets. We will measure accuracy as the total number of successes divided by the total number of trials.
Time Frame
Up to 5 minutes
Title
Trial Time as assessed by mean time duration to identify target
Description
This will be assessed by the mean duration of time to identify intended target (in seconds). For successful trials, the shorter the amount of time to conduct a task, the better the performance on said task.
Time Frame
Up to 5 minutes
Title
Success in psychophysical judgments
Description
This will be assessed by the metric error in distance judgment, that is, the correctness of identification of judgments of target features. Measurement in meters.
Time Frame
Trial Duration: estimated at up to one minute.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Criteria for inclusion of normally sighted individuals: Subject speaks English; Subjects must be an adult (at least 18 years of age); Subject has the cognitive and communication ability to participate in the study (i.e., follow spoken directions, perform tests, and give feedback); Subject is willing to conduct psychophysics testing up to 4-6 hours per day of testing on 3-5 consecutive days; Subject has visual acuity of 20/40 or better (corrected); Subject is capable of understanding participant information materials and giving written informed consent. Subject is able to walk unassisted Criteria for inclusion of Argus II users: The inclusion criteria for the study are the following: Subject is at least 25 years of age; Subject has been implanted with the Argus II system; Subject's eye has healed from surgery and the surgeon has cleared the subject for programming; Subject has the cognitive and communication ability to participate in the study (i.e., follow spoken directions, perform tests, and give feedback); Subject is willing to conduct psychophysics testing up to 4-6 hours per day of testing on 3-5 consecutive days; Subject is capable of understanding patient information materials and giving written informed consent; Subject is able to walk unassisted. Exclusion criteria for all subjects is the following: Subject is unwilling or unable to travel to testing facility for at least 3 days of testing within a one-week timeframe; Subject does not speak English; Subject has language or hearing impairment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seth Billings, Ph.D.
Phone
4437787462
Email
seth.billings@jhuapl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Tenore, Ph.D.
Phone
4437789774
Email
francesco.tenore@jhuapl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth Billings, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Medicine - Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gislin Dagnelie, PhD
Phone
410-614-4822
Email
gislin@lions.med.jhu.edu
First Name & Middle Initial & Last Name & Degree
Gislin Dagnelie, PhD
Facility Name
Johns Hopkins Applied Physics Laboratory
City
Laurel
State/Province
Maryland
ZIP/Postal Code
20723
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seth Billings, Ph.D.
Phone
443-778-7462
Email
seth.billings@jhuapl.edu
First Name & Middle Initial & Last Name & Degree
Seth Billings, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results from this study will be disseminated through conference presentations and peer-reviewed publications. However, IPD will not be shared outside the study team.

Learn more about this trial

Environmental Localization Mapping and Guidance for Visual Prosthesis Users

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