CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Navigation system mode: Argus Vision +8 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04359108
NCT04359108N/ACompleted

Environmental Localization Mapping and Guidance for Visual Prosthesis Users

Johns Hopkins University·interventional·Posted Apr 24, 2020·Updated Mar 10, 2025

In Brief

A clinical study evaluating Navigation system mode: Argus Vision, Navigation system mode: Depth Vision, and 7 other interventions for Retinitis Pigmentosa and 2 related conditions. Completed, enrolled 26 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 24, 2020
Enrollment StartMar 16, 2021
Primary CompletionSep 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.2 years ago

Interventions

Navigation system mode: Argus Visiondevice

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.

Navigation system mode: Depth Visiondevice

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

Navigation system mode: Depth Vision with Haptic / Audiodevice

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

Navigation system mode: Haptic / Audiodevice

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.

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

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

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

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

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

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

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

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

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

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