Home Monitoring of Diabetic Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in visual acuity
研究概览
简要总结
Diabetic macular edema (DME) is part of diabetic retinopathy (DR) and a leading cause of central visual loss in people with diabetes . Most patients require pharmacological inhibition using anti-vascular endothelial growth factor (VEGF) agents with multiple monitoring visits that include optical coherence tomography (OCT), visual acuity test, and multiple injections.The substantial visit frequency puts pressure on ophthalmic clinics, and can impose a tremendous burden on both patients and their caregivers. Therefore, self-service examination instruments that can be portable and fast-moving become the key for realizing tele-medicine. Recently, the investigators have developed a portable, self-administrated home OCT machine, which is designed for home-based OCT scanning and monitoring for patients with retinal diseases including DME, age related macular degeneration (AMD) and choroidal neovascularization (CNV) that require multiple anti-VEGF injections. The investigators have confirmed its image quality and validated the retinal thickness measurements obtained from this device by comparing with hospital OCT (staff-administrated and clinic-based).In this study, the investigators will conduct a randomized clinical trial (RCT) to compare the efficacy and cost-effectiveness of a home OCT monitoring model versus standard hospital care model for patients with diabetic macular edema who need anti-VEGF injections.
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
- Single (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
- •Age ≥18 years;
- •Diagnosis of diabetic macular edema:
- •Type 1 or type 2 diabetes mellitus;
- •Center-involved macular edema;
- •Willing to receive anti-VEGF treatment;
- •Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCT examination;
- •Able to operate self-administratedhome OCT by themselves or with the help of family;
- •Travel time from home to hospital: within 2 hours driving.
- •Able and willing to provide informed consent.
排除标准
- •History of systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization. (These drugs should not be used during the study);
- •History of corticosteroid treatment (intravitreal or peribulbar) at any time in the past 4 months;
- •History of macular laser photocoagulation in the past 4 months;
- •Macular edema due to reasons other than diabetes;
- •Coexisting ocular diseases that might alter visual acuity during the course of the study, such as retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.);
- •Hypertension (systolic blood pressure (BP) above 180 or diastolic BP above 110);
- •History of myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization;
- •Pregnant or lactating;
- •Currently participating in other clinical trials;
结局指标
主要结局
Changes in visual acuity
时间窗: 12 weeks
Changes in visual acuity from baseline to 12 weeks adjusted for baseline visual acuity
次要结局
- Changes in visual acuity after 24 weeks(24 weeks)
- Number of visits(12 weeks)
- Central subfield thickness change as measured by optical coherence tomography(12 weeks)
- Changes in visual acuity after 48 weeks(48 weeks)
- Gains or losses in visual acuity(12 weeks)
- The costs of treatment(12 weeks)
- Number of intravitreal injections(12 weeks)