Modulating Ocular/Retinal Blood Flow and Visual Function in Retinitis Pigmentosa
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Significant changes from baseline in Goldmann visual field area in both eyes
研究概览
简要总结
Measures of vision in RP patients receiving promising therapy using transcorneal electrical stimulation.
详细描述
Retinitis pigmentosa (RP) is a slowly progressive retinal degeneration for which there is no proven treatment. Patients are interested in trying alternative therapies to try to reduce their vision loss, but only limited research evidence exists to support their use and potential benefit. The goal of this research project is to gain a better understanding of possible changes in ocular and retinal blood flow and measures of vision in RP patients receiving two promising therapies, electroacupuncture and transcorneal electrical stimulation. We are currently only doing transcorneal electrical stimulation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of retinitis pigmentosa (RP)
- •Best-corrected visual acuity better than 20/400 in at least one eye
- •More than 20% loss of Goldmann Visual Field area (III4e test target) in at least one eye
- •Able and willing to participate in all study visits for a ~4-6 month period
- •Provide informed consent
排除标准
- •Very severe vision losses in both eyes (e.g., hand motions or light perception only) with difficulty performing the proposed vision tests
- •Vision loss due to ocular diseases other than RP, cystoid macular edema, or cataracts
- •Schedules do not permit participation in all study visits
- •Previous acupuncture or TES treatment for RP
- •Inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (cognitive impairment)
- •Dementia; Long or short-term memory loss
- •Unable to read or speak English
- •Smoking, excessive alcohol, or illegal drug use
- •Receiving current psychiatric care (i.e. unstable emotional and mental health status)
- •History of excessive bleeding
- •Reduced general health and/or systemic medications that may diminish the potential response to the electroacupuncture treatments
- •Implanted cardiac pacemaker
- •Pregnancy
结局指标
主要结局
Significant changes from baseline in Goldmann visual field area in both eyes
时间窗: twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation
Using Haig-Streit Octopus perimeter
次要结局
- Changes in Macular edema Optical Coherence Tomography (OCT)(twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation)
- Significant changes from baseline in contrast sensitivity at both 2 weeks and 6 weeks post-intervention initiation(twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation)
- Significant changes from baseline in best-corrected ETDRS visual acuity at both 2 weeks and 6 weeks post-intervention initiation(twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation)
- Significant changes from baseline in Dark adaptation function at both 2 weeks and 6 weeks post-intervention initiation(twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation)
研究者
Kenneth Seger
Associate Professor, HPD-College of Optometry
Nova Southeastern University