Non-invasive Ultrasound Retinal Stimulation for Vision Restoration

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.

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