Clinical trial NCT05914233: Non-invasive Ultrasound Retinal Stimulation for Vision Restoration
Official title: Revolutionary Non-Invasive Ultrasound Technology for Vision Restoration in Age-Related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP) Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Age-Related Macular Degeneration
Retinitis Pigmentosa
Ultrasound Therapy; Complications
Keywords: Ultrasound Stimulation
Retinal
Retinitis pigmentosa
Age-Related Macular Degeneration
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual function-Assessed by Questionnaire
timeFrame: 2 hours (average duration of procedure)
measure: Adverse Event
timeFrame: From time of procedure up to 2 hours after process completion
Secondary outcomes:
measure: Comfort Level-Assessed by Questionnaire
timeFrame: 2 hours (average duration of procedure)
Other outcomes:
Locations:
Study officials:
affiliation: University of Southern California
name: Qifa Zhou, PhD
role: PRINCIPAL_INVESTIGATOR
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