Non-invasive Ultrasound Retinal Stimulation for Vision Restoration

Study Overview
=================
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.

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

Conditions
-----------------
Age-Related Macular Degeneration, Retinitis Pigmentosa, Ultrasound Therapy; Complications

Intervention / Treatment
-----------------
* Device: Non-invasive ultrasound retinal stimulation Device


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single<br>Stimulation of the ultrasound retinal stimulation Device | Device: Non-invasive ultrasound retinal stimulation Device<br>* Record user feelings during the device is working<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual function-Assessed by Questionnaire | 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 | 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 | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound Stimulation, Retinal, Retinitis pigmentosa, Age-Related Macular Degeneration