Electrical Stimulation of the Optic Nerve in Patients With Glaucoma : Prospective Analysis of Perimetric Data up to 12 Months After Neuromodulatory Treatment.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in visual field mean deviation (MD) from baseline to post-treatment
研究概览
简要总结
The goal of this observational study is to evaluate electrical stimulation of the optic nerve with the Eyetronic Nextwave System device as a possible treatment for glaucoma.
The main question it aims to answer is:
Could this therapy be an option to counteract the loss of visual field seen in glaucoma and thus delay the progression of the disease?
Participants will have approximately 14-18 study visits during 12 months including 10 visits for the electrical stimulation treatment. The treatment involves electrically stimulating the optic nerve by an external approach via the facial skin.
详细描述
- During the study visits participants will have: general eye examination (visual acuity check, examination of the front and back of the eye, eye pressure measurement, pupil dilation), Visual field (VF) testing, Imaging the optic nerve with Optical Coherence Tomography (OCT), Optic nerve photos.
- The treatment will include ten sessions during 2 weeks on an outpatient basis in a quiet and dimly lit room with the patient comfortably seated or lying down in a reclining chair. Each treatment session will last approximately 60 minutes including the time to determine the treatment settings.
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
- •Subjects 18 years or older who have glaucoma
- •Humphrey visual field mean deviation (MD) values between - 6 dB and -20 dB
排除标准
- •Age < 18 years
- •Implanted electronic devices
- •Metallic artifacts in the head (except dentures)
- •Brain tumor
- •Pregnancy
- •Breastfeeding patients
- •Uncontrolled intraocular pressure (IOP)
- •IOP lowering medication started less than six months before enrollment
- •Any intraocular surgery less than 6 months before enrollment
- •Arterial hypertension without appropriate treatment
- •Acute retinal hemorrhage
结局指标
主要结局
Change in visual field mean deviation (MD) from baseline to post-treatment
时间窗: 12 months
Visual field testing will be performed with the Humphrey field analyzer (Carl Zeiss Meditec)
次要结局
- Change in retinal nerve fiber layer (RNFL) thickness from baseline to post-treatment(12 months)