All > Retinitis Pigmentosa
Spatial Localization and Mapping (SLAM) and object recognition technology

Navigation System for Users of a Visual Prosthesis for Visual Impairment

N/A
Recruiting
Led By Seth Billings, Ph.D.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is able to walk unassisted
Subject has been implanted with the Argus II system
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Uptrial duration: estimated at up to one minute.
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will test a new way to help people with retinal prosthetics better navigate their environment.

Eligible Conditions
  • Visual Impairment
  • Retinitis Pigmentosa
  • Visual Prosthesis

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You are able to walk without needing any help.
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You have received an implant called the Argus II system.
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Your eyesight is good enough that you can see clearly with glasses or contacts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accuracy as assessed as ratio of target identification success to total trials
Success in psychophysical judgments
Trial Time as assessed by mean time duration to identify target

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Navigation system for users of a visual prosthesisExperimental Treatment1 Intervention
This intervention will assess the feasibility of using a navigation system to aid blind users of a visual prosthesis with navigation tasks, by using the navigation system to provide navigational cues through multiple sensory modalities including vision and audition. The navigation system will be designed and developed as part of the proposed research and will interface with the Argus II retinal prosthesis system, which is an FDA approved visual prosthesis. Existing blind users of the Argus II device will be recruited for this study, and the navigation system will interface with these subjects' existing Argus II systems. Sighted subjects will also be recruited for this study, in which case the navigation system will interface with a head-mounted display (such as the Oculus Rift) worn by the sighted subjects that simulates the visual sensory information experienced by blind users of the Argus II retinal implant.

Find a site

Who is running the clinical trial?

National Eye Institute (NEI)NIH
530 Previous Clinical Trials
1,198,024 Total Patients Enrolled
2 Trials studying Visual Impairment
705 Patients Enrolled for Visual Impairment
Carnegie Mellon UniversityOTHER
72 Previous Clinical Trials
538,768 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,157 Previous Clinical Trials
14,812,452 Total Patients Enrolled
3 Trials studying Visual Impairment
469 Patients Enrolled for Visual Impairment
Seth Billings, Ph.D.Principal Investigator
Johns Hopkins University

Media Library

Environmental Localization Mapping and Guidance (Spatial Localization and Mapping (SLAM) and object recognition technology) Clinical Trial Eligibility Overview. Trial Name: NCT04359108 — N/A
Visual Impairment Research Study Groups: Navigation system for users of a visual prosthesis
Visual Impairment Clinical Trial 2023: Environmental Localization Mapping and Guidance Highlights & Side Effects. Trial Name: NCT04359108 — N/A
Environmental Localization Mapping and Guidance (Spatial Localization and Mapping (SLAM) and object recognition technology) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04359108 — N/A
Visual Impairment Patient Testimony for trial: Trial Name: NCT04359108 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrollment opportunities for this medical trial?

"Indeed, the information on clinicaltrials.gov indicates that this trial is actively enrolling volunteers. The study was initially posted in March 2021 and has been updated as recently as June 2022. Currently, 35 participants need to be signed up from 2 different medical centers."

Answered by AI

How many participants have been incorporated into this research project?

"Affirmative. Clinicaltrials.gov records that this medical trial, which launched on March 16th 2021, is currently enrolling patients. There are a total of 35 individuals required from 2 distinct clinical sites."

Answered by AI

May I be included in this trial based on my qualifications?

"This clinical trial seeks 35 individuals, aged 18 and 100, with a visually prosthetic implant. Necessary criteria include the ability to converse in English; being an adult of 25 years or older; having adequate cognitive capability to comprehend study information and provide written consent; possessing visual acuity at least 20/40 (after correction); enduring up to 6 hours per day of psychophysics testing across 3-5 consecutive days; mobility without aid; as well as Argus II surgeon clearance for programming post eye surgery healing."

Answered by AI

Does this trial allow for geriatric patients to participate?

"This medical study is looking for individuals between 18 and 100 years old. There are 30 trials that cater to the younger demographic, while 78 studies focus on patients past their senior years."

Answered by AI

Who else is applying?

What state do they live in?
Washington
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Looking for opportunities to cure retinitis pigmantosa.
Patient
Recent research and studies
clinicaltrials.govStudy
Environmental Localization Mapping and Guidance for Visual Prosthesis Users
2021. "Environmental Localization Mapping and Guidance for Visual Prosthesis Users". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04359108.
~9 spots leftby Jul 2024
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