Non-invasive Ultrasound Retinal Stimulation for Vision Restoration

February 20, 2024 updated by: Qifa Zhou, University of Southern California

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Declining to participate and inability to give informed consent.
  2. Unable to comply with the process of the research
  3. 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
  4. Unable to fixate that hinders obtaining high-quality imaging
  5. High myopia; refractive error of six diopters and above
  6. Pregnancy
  7. Subject is participating in another investigational drug or device study that may conflict with the objectives, follow-up, or testing of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual function-Assessed by Questionnaire
Time Frame: 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.
2 hours (average duration of procedure)
Adverse Event
Time Frame: From time of procedure up to 2 hours after process completion
The nature and number of Treatment-Related Adverse Events.
From time of procedure up to 2 hours after process completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort Level-Assessed by Questionnaire
Time Frame: 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
2 hours (average duration of procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Qifa Zhou, PhD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2024

Primary Completion (Estimated)

July 15, 2024

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

June 19, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-23-00143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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