Environmental Localization Mapping and Guidance for Visual Prosthesis Users
NCT04359108 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2025-03-10
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
- Retinitis Pigmentosa
- Visual Impairment
- Visual Prosthesis
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
- collaborator OTHER
-
National Eye Institute (NEI)
collaborator NIH - lead OTHER
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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