Non-invasive Ultrasound Retinal Stimulation for Vision Restoration

Sponsor
University of Southern California
Study ID
NCT05914233
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Non-invasive ultrasound retinal stimulation Device — DEVICE
    Record user feelings during the device is working

Study Details

This clinical trial aims to test the safety and feasibility of using a non-invasive ultrasound device to stimulate retinal nerve cells and restore vision in patients with age-related macular degeneration. Previous studies have shown that artificial stimulation, such as electric and optic stimulations, can partially restore vision, but these methods are invasive and pose surgical risks. The study aims to develop a non-invasive method for retinal stimulation. The investigators will follow the FDA guidelines to limit the ultrasound power and adhere to all clinical trial regulations to ensure all participants' safety. The main questions the investigators aim to answer are: * Is using high-frequency ultrasound safe using a wearable device for localized retinal neural activity stimulation? * Does the stimulation through the device restore vision in patients with age-related macular degeneration? Participants in this study will be asked to undergo Optical Coherence Tomography (OCT) scanning before and after the ultrasound stimulation to evaluate the device's safety. Then, they will receive five stimulation-rest cycles and complete a questionnaire to report what they see and how they feel during the device's operation.

Key Dates

First listed
Jun 22, 2023
Start date
Jan 10, 2027
Status verified
Jan 2026
Primary completion
Jan 15, 2028
Completion
Jul 15, 2028

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single
    Stimulation of the ultrasound retinal stimulation Device

Primary Outcome Measure

Visual function-Assessed by Questionnaire [ Time Frame: 2 hours (average duration of procedure) ]

Central Contacts

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Age-related macular degeneration trialsOphthalmology trialsRetina trials

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