Non-invasive Ultrasound Retinal Stimulation for Vision Restoration

Sponsor

University of Southern California (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05914233

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration Retinitis Pigmentosa Ultrasound Therapy; Complications	Device: Non-invasive ultrasound retinal stimulation Device	N/A

Detailed Description

This clinical trial aims to evaluate the efficacy and safety of a new non-invasive ultrasound retinal stimulation device for vision restoration in patients with age-related macular degeneration. The investigators will take the following measures:

The study population will consist of patients with age-related macular degeneration for whom traditional medical treatments have been ineffective and for whom there are no other viable treatment options.
The investigators will follow the FDA guidelines and adhere to all regulations related to clinical trials to ensure the safety of all participants.
The investigators will obtain informed consent from each participant and ensure that they fully understand the risks and benefits of the study before enrolling.
The investigators will closely monitor each participant during the study and record any adverse events or complications.
The investigators will use high-frequency ultrasound for localized stimulation, which is safe and effective in other studies.

Participants will receive stimulation from the non-invasive ultrasound device for five cycles and complete a questionnaire about their experiences. The researchers will analyze the results to determine the efficacy and safety of the device.

With these measures in place, The investigators believe that the study design and methodology are appropriate and will result in a low-risk study that meets the FDA's requirements for clinical trials.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Tremendous development has been achieved in the matrix ultrasound transducer. The investigators build the signal element ultrasound transducer to provide a stable energy release to stimulate a particular area. The investigators can limit the ultrasound focus to a minor point. The neuron activities induced by the focused 3 Megahertz (MHz) transducers have shown a spatial resolution of 250±50 µm. According to previous study, the Intensity Spatial-Peak Pulse-Average (ISPPA.3) is 26 (Under FDA suggestion of 28).Tremendous development has been achieved in the matrix ultrasound transducer. The investigators build the signal element ultrasound transducer to provide a stable energy release to stimulate a particular area. The investigators can limit the ultrasound focus to a minor point. The neuron activities induced by the focused 3 Megahertz (MHz) transducers have shown a spatial resolution of 250±50 µm. According to previous study, the Intensity Spatial-Peak Pulse-Average (ISPPA.3) is 26 (Under FDA suggestion of 28).

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Revolutionary Non-Invasive Ultrasound Technology for Vision Restoration in Age-Related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP) Patients

Anticipated Study Start Date :

Jul 15, 2023

Anticipated Primary Completion Date :

Jul 15, 2024

Anticipated Study Completion Date :

Jul 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Stimulation of the ultrasound retinal stimulation Device	Device: Non-invasive ultrasound retinal stimulation Device Record user feelings during the device is working

Arm

Intervention/Treatment

Experimental: Single

Stimulation of the ultrasound retinal stimulation Device

Device: Non-invasive ultrasound retinal stimulation Device

Record user feelings during the device is working

Outcome Measures

Primary Outcome Measures

Visual function-Assessed by Questionnaire [2 hours (average duration of procedure)]
A questionnaire will be given to participants. The answers will be recorded as "No" or "Yes." If "Yes" is selected as the participant's answer, their descriptions according to the given questions will be recorded in detail.
Adverse Event [From time of procedure up to 2 hours after process completion]
The nature and number of Treatment-Related Adverse Events.

Secondary Outcome Measures

Comfort Level-Assessed by Questionnaire [2 hours (average duration of procedure)]
A scale of 0 to 5 will be provided to the participants. 0 is no feeling, and 5 is very pain or uncomfortable

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of AMD (regardless of stage and type) or RP. At least two volunteers should diagnose with RP.
Age 18 years or older
No other eye-related health conditions
No allergic history to commercial ultrasound gel
Must be willing and able to comply with the protocol testing

Exclusion Criteria:

Declining to participate and inability to give informed consent.
Unable to comply with the process of the research
If the volunteer has optic nerve disease, including the history of glaucoma, optic neuropathy, or other confirmed damage to optic nerve or visual cortex damage
Unable to fixate that hinders obtaining high-quality imaging
High myopia; refractive error of six diopters and above
Pregnancy
Subject is participating in another investigational drug or device study that may conflict with the objectives, follow-up, or testing of this study