Environmental Localization Mapping and Guidance for Visual Prosthesis Users

NCT04359108 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-03-10

Study results available
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Summary

This study is driven by the hypothesis that independent navigation by blind users of visual prosthetic devices can be greatly aided by use of an autonomous navigational aid that provides information about the environment and guidance for navigation through multimodal sensory cues. For this study, the investigators developed a navigation system that uses on-board sensing to map the user's environment and compute navigable paths to desired destinations in real-time. Information regarding obstacles and directional guidance is communicated to the user via a combination of sensory modalities including limited vision (through the user's visual prosthesis), haptic, and audio cues. This study evaluates how effectively this navigational aid improves prosthetic vision users' ability to perform navigational tasks. The participants for this study include both retinal prosthesis users of the Argus II Retinal Prosthesis System (Argus II) and normally sighted individuals who use a virtual reality headset to simulate the limited vision of the Argus II system.

Conditions

Interventions

DEVICE

Navigation system mode: Argus Vision

This intervention uses the navigational aid with the output sensory modalities configured as follows: * Vision: Argus mode * Haptics: none * Audio: none Since this mode only provides the standard Argus vision, it is equivalent to using the base Argus II system without the navigational aid.

DEVICE

Navigation system mode: Depth Vision

This intervention uses the navigational aid with the output sensory modalities configured as follows: * Vision: Depth mode (at Argus II resolution and field-of-view) * Haptics: none * Audio: none

DEVICE

Navigation system mode: Depth Vision with Haptic / Audio

This intervention uses the navigational aid with the output sensory modalities configured as follows: * Vision: Depth mode (at Argus II resolution and field-of-view) * Haptics: yes * Audio: yes

DEVICE

Navigation system mode: Haptic / Audio

This intervention uses the navigational aid with the output sensory modalities configured as follows: * Vision: none * Haptics: yes * Audio: yes Since this mode does not provide any visual feedback, it is equivalent to using navigational aid completely blind without a visual prosthesis.

DEVICE

Navigation system mode: High Field-of-View Depth Vision

This intervention uses the navigational aid with the output sensory modalities configured as follows: * Vision: High Field-of-View Depth mode (at twice the Argus II resolution and field-of-view along each dimension) * Haptics: none * Audio: none

DEVICE

Distance test vision mode: Low Resolution / Low Field-of-View

This intervention performs the relative distance to two obstacles test with the user's vision output configured as follows: * Resolution: Low * Field-of-View: Low

DEVICE

Distance test vision mode: Low Resolution / High Field-of-View

This intervention performs the relative distance to two obstacles test with the user's vision output configured as follows: * Resolution: Low * Field-of-View: High

DEVICE

Distance test vision mode: High Resolution / Low Field-of-View

This intervention performs the relative distance to two obstacles test with the user's vision output configured as follows: * Resolution: High * Field-of-View: Low

DEVICE

Distance test vision mode: High Resolution / High Field-of-View

This intervention performs the relative distance to two obstacles test with the user's vision output configured as follows: * Resolution: High * Field-of-View: High

Sponsors & Collaborators

Principal Investigators

  • Seth Billings, Ph.D. · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2024-09-30
Completion
2024-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04359108 on ClinicalTrials.gov