Diabetic Macular Edema Found by OCT Utilization at Non-ophthalmic Diabetes Care Visits
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Diabetes
- 发起方
- Joslin Diabetes Center
- 入组人数
- 385
- 试验地点
- 4
- 主要终点
- Rates of Retina Care Referral for Patients With Diabetic Macular Edema
- 状态
- 已完成
- 最后更新
- 8年前
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.
研究者
入排标准
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
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)