Status:
COMPLETED
Environmental Localization Mapping and Guidance for Visual Prosthesis Users
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Carnegie Mellon University
National Eye Institute (NEI)
Conditions:
Retinitis Pigmentosa
Visual Impairment
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 a...
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 Pr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04359108
Start Date
March 16 2021
End Date
September 30 2024
Last Update
March 10 2025
Active Locations (2)
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1
Johns Hopkins Medicine - Wilmer Eye Institute
Baltimore, Maryland, United States, 21205
2
Johns Hopkins Applied Physics Laboratory
Laurel, Maryland, United States, 20723