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NCT05914233Not yet recruiting

Non-invasive Ultrasound Retinal Stimulation for Vision Restoration

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

Source: ClinicalTrials.gov · Last updated 8 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
5 (estimated)
First submitted
8 May 2023
Start date
10 Jan 2027
Primary completion date
15 Jan 2028
Lead sponsor
University of Southern California
NCT number
NCT05914233

What you commit to

  • Study type: Interventional
  • Planned participants: 5
  • From 10 Jan 2027 to the primary completion date, 15 Jan 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subject is participating in another investigational drug or device study that may conflict with the objectives, follow-up, or testing of this study

Other illness

  • 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

Other

  • Declining to participate and inability to give informed consent.
  • Unable to comply with the process of the research
  • Unable to fixate that hinders obtaining high-quality imaging
  • High myopia; refractive error of six diopters and above
  • Pregnancy

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.