NCT04359108Completed

Environmental Localization Mapping and Guidance for Visual Prosthesis Users

Source: ClinicalTrials.gov · Last updated 10 Mar 2025

Brief summary (registry, in English)

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.

Status (registry): Completed
Study type: Interventional
Enrollment: 26 (actual)
First submitted: 21 Apr 2020
Start date: 16 Mar 2021
Primary completion date: 30 Sept 2024
Lead sponsor: Johns Hopkins University
Diseases: Retinitis pigmentosa
NCT number: NCT04359108

What you commit to

Study type: Interventional
Participants enrolled: 26
From 16 Mar 2021 to the primary completion date, 30 Sept 2024
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

Subject has language or hearing impairment.

Other

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;

Criteria the registry did not label

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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Johns Hopkins Medicine - Wilmer Eye Institute Coordinator of this site? Confirm its status	Baltimore	United States	Unknown status
Johns Hopkins Applied Physics Laboratory Coordinator of this site? Confirm its status	Laurel	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.