Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT05914233
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2023-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-invasive Ultrasound Retinal Stimulation for Vision Restoration
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
Revolutionary Non-Invasive Ultrasound Technology for Vision Restoration in Age-Related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP) Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: