What is the mechanism of action of this treatment?

The most common treatments for visual impairment, particularly those involving retinal prosthesis, include technologies like Spatial Localization and Mapping (SLAM) and object recognition. These technologies work by constructing a detailed map of the user's environment and accurately locating the user within that map. This is achieved through the integration of visual and auditory feedback, which helps users navigate their surroundings more effectively. For patients with visual impairment, these advancements are crucial as they significantly enhance spatial awareness and mobility, thereby improving their overall quality of life and independence.

What side effects are associated with this type of intervention?

The most common treatments for visual impairment, particularly those involving retinal prosthesis and similar technologies like SLAM and object recognition, can have several side effects. Users of retinal prostheses may experience issues such as eye discomfort, inflammation, and potential infection at the implant site. Additionally, there can be challenges with the device's functionality, such as limited visual field and resolution, which may affect the user's ability to navigate effectively. Other side effects might include headaches and visual disturbances as the brain adapts to the new visual input.

What prior FDA approvals exist?

The FDA has approved the Argus II Retinal Prosthesis System, which is designed to restore some vision to people with severe retinitis pigmentosa. This device works by converting video images captured by a miniature camera mounted on the patient's glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes implanted on the surface of the retina. These pulses stimulate the retina's remaining cells, resulting in the perception of patterns of light in the brain. While the Argus II is the primary FDA-approved device in this category, ongoing research, such as the incorporation of SLAM and object recognition technology, aims to further enhance the functionality and user experience of retinal prosthetics.

What other types of research exist?

Promising novel alternatives to SLAM and Object Recognition Technology for enhancing environmental mapping and user localization for retinal prosthesis users include: 1) Augmented Reality (AR) systems that overlay digital information onto the real world to assist with navigation and object identification. 2) Advanced auditory feedback systems that provide spatial audio cues to help users understand their environment. 3) Machine learning algorithms that predict and adapt to user behavior and preferences for more personalized navigation assistance. 4) Integration of haptic feedback devices that convey environmental information through touch.

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Spatial Localization and Mapping (SLAM) and object recognition technology

Navigation System for Vision Impairment (SLAM Trial)

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 must be an adult (at least 18 years of age)

Subject is able to walk unassisted

Must not have

Subject does not speak English

Subject is unwilling or unable to travel to testing facility for at least 3 days of testing within a one-week timeframe

Timeline

Screening 3 weeks

Treatment Varies

Follow Up trial duration: estimated at up to one minute.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new technology that helps blind people navigate by creating a map of their surroundings and providing visual and sound cues. It targets legally blind individuals using the Argus II retinal prosthesis. The system helps users understand where they are and what objects are around them. The Argus II retinal prosthesis system has been developed to restore some vision to patients blind due to retinitis pigmentosa or outer retinal degeneration.

Who is the study for?

This trial is for adults with vision impairments or specific conditions like Retinitis Pigmentosa who can follow instructions, give feedback, and speak English. They should be able to participate in testing for up to 6 hours a day over several days, walk unassisted, have good cognitive abilities, and visual acuity of at least 20/40 when corrected.

What is being tested?

The study tests a navigation system that uses Spatial Localization and Mapping (SLAM) technology along with object recognition to help users of visual prostheses navigate their environment. It will involve both sighted individuals using VR headsets and actual prosthesis users.

What are the potential side effects?

Since this trial involves non-invasive technology rather than medication or surgery, traditional side effects are not expected. Participants may experience discomfort from prolonged use of VR headsets or fatigue from extensive testing sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 18 years old.

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I can walk by myself without help.

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I am at least 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

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I cannot or will not go to the testing facility for 3 days within a week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 minutes

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for visual impairment, particularly those involving retinal prosthesis, include technologies like Spatial Localization and Mapping (SLAM) and object recognition. These technologies work by constructing a detailed map of the user's environment and accurately locating the user within that map. This is achieved through the integration of visual and auditory feedback, which helps users navigate their surroundings more effectively. For patients with visual impairment, these advancements are crucial as they significantly enhance spatial awareness and mobility, thereby improving their overall quality of life and independence.

Interventions Addressing Vision, Visual-perceptual Impairments Following Acquired Brain Injury: A Cross-sectional Survey.A Review of Cochrane Systematic Reviews of Interventions Relevant to Orthoptic Practice.