NCT05626491招募中不适用
Evaluate the Safety and Efficacy of Repetitive, Transorbital Alternating Current Stimulation (rtACS) for the Treatment of Glaucoma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Change from baseline in visual field assessed by Humphrey Visual Field Index (VFI).
研究概览
简要总结
The overall aim of this study is to see whether long-term electrical stimulation with a home-stimulation device works well and is safe for the treatment of open-angle glaucoma. Open-Angle Glaucoma is a disease where the nerves in the back of your eye die off faster than expected regardless of your eye pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 glaucoma characterized by the following features: Mean deviation (MD) worse than -3 on Humphrey Visual Field 24-2 testing. Reliable visual field measures, fixation losses do not exceed 20% and false positives do not exceed 20%.
- •Visual Field Index between 10 and 90%
- •Corrected visual acuity ≥ 1.00 (logMAR), 20/200 (Snellen), 0.10 (decimal)
- •In the opinion of the investigator the participant's eye pressure must be clinically stable.
- •If a participant has two eyes meeting study criteria, the worse eye as determined by mean deviation. If both eyes qualify and have the same MD, 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 pathological nystagmus
- •Participant has evidence of visually significant retinopathy including but not limited to Diabetic retinopathy or retinitis pigmentosa.
- •Participant has evidence of corneal opacification or lack of optical clarity.
- •Participant has uveitis or other ocular inflammatory disease.
- •Participant has any electric or electronic implants such as a pacemaker.
- •Participant has acute conjunctivitis.
- •Participant has acute autoimmune disease.
- •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. Including but not limited to all forms of dementia.
- •Unresected brain tumors
- •Implanted intracranial magnetic metals (metallic implants in the head / skull such as clamps, coils, ventriculo-peritoneal shunts, endoprostheses, etc.), which are not MRI-compatible. Note: metallic dental implants and titanium screws or plates are acceptable
- •Patients with any skin damage.
- •Children and comatose patients.
- •Patients with history of epileptic seizure within the last 10 years.
- •Patients with uncontrolled systemic hypertension or uncontrolled diabetes.
- •Self-reported alcohol or illicit drug addictions within the last 12 months.
- •Participant is not able to travel, to comply with the requirements of the study or not willing to complete the schedule of events (SOE) and/or unable to confirm follow-up participation
- •Prior participation in a vision training/stimulation study in the last 12 months
研究组 & 干预措施
Active SAVIR Alpha Synch Mobile device (SASm)
Experimental
Patients will receive active treatment with the device every other day over 8 weeks.
干预措施: Repetitive, Transorbital Alternating Current Stimulation (rtACS) (Device)
Sham SAVIR Alpha Synch Mobile device (SASm)
Sham Comparator
Patients will receive sham treatment (no active stimulation) with the device every other day over 8 weeks.
干预措施: Sham Repetitive, Transorbital Alternating Current Stimulation (rtACS) (Device)
结局指标
主要结局
Change from baseline in visual field assessed by Humphrey Visual Field Index (VFI).
时间窗: Baseline through 6 months
次要结局
- Change from baseline in visual field assessed by Humphrey Mean Deviation (MD).(Baseline through 6 months)
- Change from baseline in visual field assessed by Pelli-Robson Contrast Sensitivity.(Baseline through 6 months)
- Change from baseline in visual acuity as assessed by the Snellen visual acuity test.(Baseline through Month 6)
研究者
Jeffrey L Goldberg
Professor of Ophthalmology
Stanford University
研究点 (4)
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