Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Function After Ocular Trauma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity
研究概览
简要总结
Transcorneal Electrical Stimulation (TES) using the "OkuStim®" device delivers electrical impulses to damaged and/or diseased photoreceptor cells. This electric stimulation of the retina may help to preserve visual acuity and/or the visual field.
详细描述
The finely detailed, precise anatomy of the retina and optic nerve capture light impulses from the environment through a biochemical process and then transmit these images to the brain via electrical impulses conducted from the inner retina to the optic nerve and ultimately to the occipital cortex.
In the human eye, three types of specialized ganglion cells transmit electrical impulses to the brain. Among these three cell populations are rod and cone cells, which participate in the photo-transduction step of light perception, along with other light sensitive ganglion cells. It is a system whereby the photosensitive pigment rhodopsin (or one of its analogs) rearranges in response to light, and this change in chemical structure fires electrical impulses to the brain which in turn interprets the incoming impulses as a visual image.
Transcorneal Electrical Stimulation (TES) using the "OkuStim®" device delivers electrical impulses to damaged and/or diseased photoreceptor cells. This electric stimulation of the retina may help to preserve VA and/or the visual field.
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
- •You are 18 years or older.
- •You have sustained trauma (more than 3 months before this study) OR been diagnosed with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) (more than 6 months before this study) OR been diagnosed with Multiple Sclerosis (MS) and suffered visual loss (more than 3 months before this study).
- •You are willing and able to give written informed consent.
- •You are able to commit to enrolling in the study during the full time period of up to 6 months.
排除标准
- •You have any other significant ophthalmologic disease or condition (such as glaucoma, retinal degeneration, proliferative diabetic retinopathy, +/- six diopters of myopia, retinal detachment, exudative age-related macular degeneration).
- •You have amblyopia (lazy eye) in affected eye, previously diagnosed.
- •You are participating in any other interventional clinical trial.
- •If you are pregnant OR a woman with childbearing potential who is unwilling to use medically acceptable means of birth control for study duration OR woman unwilling to perform a pregnancy test at study entry/screening.
- •You are unable to give signed consent due to memory, medical, communication, language, or mental health problems.
- •You are less than 18 years old.
- •You are unable or unwilling to complete the evaluation or questionnaire.
- •Visual acuity better than 20/40
- •Inability to detect phosphenes during threshold detection
- •You are on seizure medications, or have a history of epilepsy.
结局指标
主要结局
Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity
时间窗: Change from Baseline (week 1) to 1-week post initial treatment (week 8)
The primary outcomes are change in high-contrast LogMar VA from baseline (week 1) to initial post treatment (week 8). Participants read letters from a chart and receive 1 point for each letter correctly identified. Scores are converted to logMAR scale and analyzed for changes in visual acuity. Improvement in visual acuity is defined as a decrease in logMAR of 0.2 or more.
次要结局
- Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant(Change from Baseline (week 1) to 1 - week post initial treatment (week 8))
- Intra-Ocular Pressure (IOP)(Change from Baseline (week 1) to 1-week post initial treatment (week 8))
- Visual Field Mean Deviation(Change from Baseline (week 1) to 1 - week post initial treatment (week 8))
- Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Superior Quadrant(Change from Baseline (week 1) to 1 - week post initial treatment (week 8))
- Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Nasal Quadrant(Change from Baseline (week 1) to 1 - week post initial treatment (week 8))
- Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Temporal Quadrant(Change from Baseline (week 1) to 1 - week post initial treatment (week 8))
- Symbol Digit Modality Testing(Change from Baseline to 1 - week post initial treatment)
- Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Center Quadrant(Change from Baseline (week 1) to 1 - week post initial treatment (week 8))
- National Eye Institute's Visual Functioning Questionnaire - 25(Change from Baseline to 1 - week post initial treatment)
研究者
Julia Haller
Evaluation of the Effectiveness of Transcorneal Electrical Stimulation to Improve Visual Function Following Ocular Trauma
Wills Eye