Revolutionary Non-Invasive Ultrasound Technology for Vision Restoration in Age-Related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP) Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5
- 主要终点
- Adverse Event
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Subject is participating in another investigational drug or device study that may conflict with the objectives, follow-up, or testing of this study
研究组 & 干预措施
Single
Stimulation of the ultrasound retinal stimulation Device
干预措施: Non-invasive ultrasound retinal stimulation Device (Device)
结局指标
主要结局
Adverse Event
时间窗: From time of procedure up to 2 hours after process completion
The nature and number of Treatment-Related Adverse Events.
Visual function-Assessed by Questionnaire
时间窗: 2 hours (average duration of procedure)
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.
次要结局
- Comfort Level-Assessed by Questionnaire(2 hours (average duration of procedure))
研究者
Qifa Zhou
Professor
University of Southern California