NCT06685211招募中不适用
A Randomized, Sham Controlled, Masked Study to Evaluate the Efficacy of Alternating Current Stimulation Using the Eyetronic System for the Treatment of Glaucoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Visual Field Index (VFI)
研究概览
简要总结
The purpose of the study is to evaluate the efficacy, transorbital alternating current stimulation (rtACS) using the EYETRONIC for the treatment in patients with glaucoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Participant must be at least
- •Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
- •Participant's clinical diagnosis must be consistent with primary open angle glaucoma (including but not limited to normal tension, low tension or general open angle) characterized by the following features: Mean deviation (MD) worse than -6 but better than -20 on reliable Humphrey Visual Field 24-2 testing
- •Participant's eye pressure must be clinically stable, with IOP <
- •If a participant has two eyes meeting study criteria, the worse eye as determined by visual field index (VFI) or patient preference, will be deemed includable. If both eyes qualify and have the same VFI, the patient may choose which eye they are willing to enter, or else a randomization procedure will assign one eye to the study.
- •Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.
排除标准
- •Participant is unable to comply with study procedures or follow-up visits.
- •Participant has a history of ocular herpes zoster.
- •Participant has a requirement of acyclovir and/or related products during study duration. To be eligible for this study, the participant must discontinue use of these products prior to enrollment and must not continue with the products until after they have completed the study.
- •Participant has evidence of corneal opacification or lack of optical clarity.
- •Participant has uveitis or other ocular inflammatory disease.
- •Participant is receiving systemic steroids or other immunosuppressive medications.
- •Participant is currently participating in or has within the last 3 months participated in any other clinical trial of a drug by ocular (if in the study eye) or systemic administration.
- •Participant is pregnant or lactating.
- •Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments.
- •Patients with opened skull, after trepanation or with heart and brain pacemaker.
- •Patients with implanted intracranial metals such as clippings, coilings, ventriculo-peritoneal shunts, endoprosthesis etc.
- •Patients with any skin damage in the area of electrode placement.
- •Children and comatose patients.
- •Patients with recent history of epileptic seizure.
- •Patients with uncontrolled high levels of blood pressure (<160 mmHg) or uncontrolled high levels of intraocular pressure (<27 mmHg).
- •Patients abusing drugs or alcohol.
结局指标
主要结局
Visual Field Index (VFI)
时间窗: 3 Months
Measuring the change in the Visual Field Index (VFI) from baseline to month 3.
Mean Deviation (MD)
时间窗: 3 Months
Measuring the change in Mean Deviation on Visual Field from Baseline to Month 3.
Pointwise Linear Regression (PLR)
时间窗: 3 Months
Measuring the PLR of the visual field points from baseline to Month 3.
次要结局
- Ganglion Cell Layer(3 Months)
- Retinal Nerve Fiber Layer(3 Months)
- Best Corrected Visual Acuity(3 Months)
- Stead-State Visually Evoked Potential(3 Months)
- OCT-Angiography(3 Months)
- Retinal Metabolic Analysis(3 Months)
- Visual Field indicies in Non-Study Eye(3 Months)
研究者
Jeffrey L Goldberg
Professor and Chair of Ophthalmology
Stanford University
研究点 (2)
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