Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Dark-adapted (Scotopic) Full-field Stimulus Test
研究概览
简要总结
Retinitis Pigmentosa (RP) patients are interested in trying alternative therapies to attempt to slow, halt or reverse the retinal disease process, and claim success with some approaches such as acupuncture, but this potential treatment has not been put to the test of objective, rigorous scientific study conducted in western society. In this pilot study, the investigators aim to evaluate an acupuncture treatment tailored to the RP population for its feasibility to improve visual function, specifically visual field and dark adaptation. The study results may provide a basis for eye care providers' recommendations to RP patients regarding whether to consider acupuncture as a potential treatment modality. If our hypotheses regarding improvements in vision beyond typical test variability are supported, our future research goals include the conduct of a larger clinical trial with involving randomization and a placebo control for acupuncture in RP.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of retinitis pigmentosa
- •Best-corrected visual acuity better than 20/400 in at least one eye
- •More than 20% loss of Goldmann Visual Field area (III4e) in at least one eye
- •Able and willing to participate in all study visits in Baltimore for the 8-week program
- •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 treatment in the last 6 months
- •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, substance abuse, or illegal drug use
- •Receiving current psychiatric care (i.e. unstable emotional and mental health status)
- •History of excessive bleeding
结局指标
主要结局
Dark-adapted (Scotopic) Full-field Stimulus Test
时间窗: initial response within 2 weeks after completion of treatment
次要结局
- Goldmann visual fields(initial response within 2 weeks of treatment completion)
- PC-based vision tests (visual acuity, contrast sensitivity, visual field)(initial response within 2 weeks of treatment completion)
- ETDRS visual acuity(initial response within 2 weeks of treatment completion)
- Pelli-Robson contrast sensitivity(initial response within 2 weeks of treatment completion)
研究者
Ava Bittner
Principal Investigator
Johns Hopkins University