Near to Infrared Light Stimulation Effect on Ganglion Cell Function in Glaucomatous Optic Neuropathy
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pattern electroretinogram response
研究概览
简要总结
The purpose of the study is to evaluate if near-to-infrared light stimulation can improve retinal ganglion cell function in glaucomatous patients.
详细描述
Ganglion cell dysfunction in glaucomatous optic neuropathy has been ascribed to ganglion cell electrophysiological inactivation and to apoptotic cell death. Near-to-infrared light stimulation has been used to induce mitochondrial activation and to prevent apoptotic death through mitochondrial cytochrome oxidase c stimulation. Near-to-infrared light stimulation might be useful to induce ganglion cell activation and inhibit apoptotic cell death.
We propose that near-to-infrared light stimulation can be used as an adjuvant treatment combined with ocular hypotensive treatment in glaucomatous patients.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnose of Ocular Hypertension (cup to disk ratio 0,6 or less, normal Humphrey 24-2 visual field with aplanatic IOP over 21 mmHg) or Mild Glaucoma (cup to disk ratio 0,6 to 0,8, characteristic Humphrey 24-2 visual field defect PSD between 3 and 6 dB).
- •Visual acuity 20/40 or better
排除标准
- •Diabetic retinopathy, Multiple Sclerosis, Parkinson disease
- •Refractive error of 3 diopters or more
结局指标
主要结局
Pattern electroretinogram response
时间窗: Every two weeks for 4 months
次要结局
- OCT ganglion cell layer average thickness, Visual Field defects(Every month for four months)