NCT04776343Unknown不适用
Prospective, Randomized Study Comparing Two Populations of Patients Treated With Anti VEGF for Diabetic Macular Edema, One Being Followed at the Hospital and the Other One Being Followed at Home Using a Software Allowing Self-assessment of Visual Acuity
Hospital St. Joseph, Marseille, France1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2021年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Rate of patients with VA evolution in the two groups
研究概览
简要总结
Verify the reliability of VA measured every week at home, by the patient using a TC, compared to the reliability of VA also measured by the patient using a TC but every 2 month at the hospital, during standard DME follow-up visits
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Will be included in the study, patients with all of the following criteria:
- •aged ≥ 25 years old (the minimum age is set at 25 years old in order to include patient with controlled diabetes);
- •diagnosed with DME;
- •followed and treated by anti-VEGF IVT in the ophthalmology debarment at Hopital Saint Joseph Marseille;
- •having a VA score ≥ 20/100;
- •able to understand the study and to use a TC;
- •having an internet access at home;
- •having given free and informed written consent;
- •being affiliated with or benefiting from a social security scheme.
排除标准
- •Will not be included in the study, patients with one of the following criteria:
- •treated for another pathology that DME;
- •already participating to another research study;
- •pregnant or breastfeeding woman;
- •subject to a measure for the protection of justice.
结局指标
主要结局
Rate of patients with VA evolution in the two groups
时间窗: 36 months
rate in percentage
次要结局
- Variation of the VA measured using ETDRS scale on TC for the patients followed at the hospital(36 months)
- Change in the total cost per patient for patient in group 1 compared to group 2.(36 months)
- Variation of the VA measured using ETDRS scale on TC for the patients followed at home(36 months)
- Number of follow-up and injection visits for each patient according to their group(36 months)
- Average time between the follow-up visit and the IVT (if performed)(36 months)
- Variations in foveolar thickness and maximum central retinal thickness on OCT(36 months)
- Change in quality of life for patients in group 1 compared to group 2(36 months)
研究者
研究点 (1)
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