Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine- SIGHT 2: A Pragmatic Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Rate of vision threatening eye disease (glaucoma/suspected glaucoma, visually significant cataract, diabetic retinopathy)
研究概览
简要总结
To compare eye disease detection rates at a Federally Qualified Health Center between a technology-enhanced protocol and standard optometric clinical examination for three of the leading causes of blindness: glaucoma, diabetic retinopathy, and visually significant cataract.
详细描述
See study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistician assessing the main outcome measure will be masked. A second statistician, not masked to treatment allocation, will tabulate weekly reports of adverse events by treatment group for review by the medical monitor.
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
- •Speak English, Spanish, Arabic, Chinese, French, Hindi, Finnish, Albanian, Russian or Tagalog
排除标准
- •significant eye pain
- •sudden decrease in vision within one week
- •binocular diplopia
- •cognitive impairment
- •pregnancy
- •previously declined participation
研究组 & 干预措施
Control, standard optometric examination
Participants will receive usual care with an optometrist with a biomicroscopic exam at the Federally Qualified Health Center to identify eye disease.
干预措施: Technology enhanced eye disease detection protocol (Other)
Control, standard optometric examination
Participants will receive usual care with an optometrist with a biomicroscopic exam at the Federally Qualified Health Center to identify eye disease.
干预措施: Standard optometric examination (Other)
Intervention, technology enhanced eye disease detection protocol
Participants will receive a technology enhanced eye disease detection protocol from ophthalmic technicians that includes measurements of visual function such as visual acuity, refraction, intraocular pressure, pachymetry, external eye and fundus photography, and optical coherence tomography of the macula and retinal nerve fiber layer. The optometrist at the Federally. Qualified Health Center will then use a protocol to grade the testing and identify eye disease. The results of the grading will inform whether the person receives a brief appointment with the optometrist (if no disease is detected) or an in-depth appointment with the optometrist (if there is disease detected).
干预措施: Standard optometric examination (Other)
Intervention, technology enhanced eye disease detection protocol
Participants will receive a technology enhanced eye disease detection protocol from ophthalmic technicians that includes measurements of visual function such as visual acuity, refraction, intraocular pressure, pachymetry, external eye and fundus photography, and optical coherence tomography of the macula and retinal nerve fiber layer. The optometrist at the Federally. Qualified Health Center will then use a protocol to grade the testing and identify eye disease. The results of the grading will inform whether the person receives a brief appointment with the optometrist (if no disease is detected) or an in-depth appointment with the optometrist (if there is disease detected).
干预措施: Technology enhanced eye disease detection protocol (Other)
结局指标
主要结局
Rate of vision threatening eye disease (glaucoma/suspected glaucoma, visually significant cataract, diabetic retinopathy)
时间窗: Visit 1(day 1)
Rate of glaucoma/suspected glaucoma
时间窗: Visit 1 (Day 1)
Rate of visually significant cataract
时间窗: Visit 1(day 1)
Visually significant cataract is defined as presence of cataract with best corrected visual acuity ≤ 20/40 in the absence of other pathology.
Rate of diabetic retinopathy
时间窗: Visit 1(day 1)
次要结局
- Visual Function(6 weeks)
- Rate of disease in second allocation(6 weeks)
- Visual Function(6 weeks)
研究者
Paula Anne Newman-Casey
Professor of Ophthalmology and Visual Sciences
University of Michigan