Novel Telehealth Technologies to Detect and Manage Glaucoma and Vision-threatening Eye Diseases in High-risk Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Glaucoma Diagnosis or Glaucoma Suspect Requiring Treatment
研究概览
简要总结
The vast majority of glaucoma cases in the United States go undetected and untreated until the late stages of the disease. Open-angle glaucoma is a progressive condition that is asymptomatic in its early to moderate stages and may be amenable to screening through telemedicine-based approaches. This study is a randomized trial to evaluate whether glaucoma screening with established tests (e.g., optical coherence tomography, fundus photography, and tonometry) is more effective for detecting undiagnosed glaucoma cases compared to education alone or delayed intervention.
详细描述
Specific Aim 1: To determine the effectiveness of a telemedicine-based glaucoma screening program for detecting glaucoma. The investigators hypothesize that a mobile screening intervention incorporating optical coherence tomography (OCT), fundus photography, and tonometry will result in a greater number of new glaucoma diagnoses compared to education alone or delayed treatment.
Specific Aim 2: To determine whether a telemedicine-based glaucoma screening program provides benefits beyond glaucoma detection. The investigators hypothesize that (A) individuals randomized to the screening intervention will have higher rates of cataract surgery and distance vision correction one year after screening, and (B) those in the screening intervention will report higher vision-related quality of life one year after screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Black people aged 50 years or older
- •Hispanic people aged 65 years or older
- •People with diabetes aged 50 years or older
- •Must have been seen at the Federally Qualified Health Center (FQHC) within the past month
排除标准
- •Patients without a valid phone number or mailing address
- •Patients who have had an optometry appointment within the past year
研究组 & 干预措施
Screening
干预措施: Glaucoma screening with optical coherence tomography (OCT), color fundus photography, and tonometry (Other)
Education
干预措施: Educational Brochure (Other)
Delayed Education
The same as the Educational Brochure arm, but delivered at the conclusion of the study.
结局指标
主要结局
Glaucoma Diagnosis or Glaucoma Suspect Requiring Treatment
时间窗: 3 months from randomization
次要结局
- Cataract surgery(12 months)
- Eyeglasses(12 months)
- Quality of Life survey(12 months)