Non-invasive Ultrasound Retinal Stimulation for Vision Restoration
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern California
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Non-invasive ultrasound retinal stimulation Device
DeviceRecord user feelings during the device is working
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: SingleExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
2 hours (average duration of procedure)2
Adverse Event
The nature and number of Treatment-Related Adverse Events.
Time frame
From time of procedure up to 2 hours after process completionSecondary outcomes
1
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
Time frame
2 hours (average duration of procedure)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: