Diabetic Macular Edema Found by OCT Utilization at Non-ophthalmic Diabetes Care Visits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 385
- 试验地点
- 8
- 主要终点
- Rates of Retina Care Referral for Patients With Diabetic Macular Edema
研究概览
简要总结
The purpose of this protocol is to determine whether point of care optical coherence tomography (OCT) imaging combined with an OCT-guided retinal referral algorithm at primary diabetes care visits increases rates of retina specialist eye care for patients with diabetic macular edema. The hypothesis is that OCT imaging with an automated OCT-guided referral algorithm will enable identification of patients at risk for vision loss from diabetic macular edema and facilitate direct referral to retina specialists for more timely evaluation and treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Care Provider, Investigator)
盲法说明
Primary diabetes care specialists masked to results of OCT intervention
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
- •Type 1 or type 2 diabetes mellitus as evidenced by:
- •Current regular use of insulin or oral anti-hyperglycemia agents for the treatment of diabetes OR
- •Documented diabetes by American Diabetes Association and/or World Health Organization criteria
- •Age greater than or equal to 18 years old
- •Diabetes duration of 10 more years OR last measured HbA1c of 10% or more
- •Able and willing to participate in study procedures and comply with study follow-up visits
- •Able to give informed consent for study participation
- •Not moving out of the study area during the 1 year follow-up period
排除标准
- •Unable to cooperate with the OCT image acquisition procedure or other study procedures
- •Unable or unwilling to comply with the study follow-up visits
- •Unable or unwilling to sign form for release of retinal medical records
研究组 & 干预措施
OCT imaging
All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status.
干预措施: OCT imaging (Device)
结局指标
主要结局
Rates of Retina Care Referral for Patients With Diabetic Macular Edema
时间窗: Baseline visit
Percentage of participants who are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm
次要结局
- Retinal Referral Rates for Patients With DME(Baseline visit)
- Rates of Retinal Treatment Over 1 Year for Patients With DME(9 months)
- Rates of Retinal Treatment for Patients With DME(One month)