Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- CSME needing Photocoagulation
研究概览
简要总结
This project aims to validate a predictive model of diabetic retinopathy progression to clinically significant macular edema (CSME) needing photocoagulation and/or vision loss. The Coimbra Predictive Model (CPM), based on retinal thickness, microaneurysms number, HbA1C and LDL levels, established on a set of 52 diabetic patients, will be tested on a population of 400 patients/eyes to be enrolled into the study. These patients will perform 2 visits at 6-month interval (V0 and V6) to classify each patient into one of the 3 previously established phenotypes. Two years after (V24) patients will be reexamined. The occurrence of end-points, achieved by the patients, are expected to validate our predictive model.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes type 2 according to 1985 WHO criteria.
- •Age between 35 and 75 years.
- •Mild non-prolipherative retinopathy (based on ETDRS criteria)
- •Best Corrected Visual acuity >20 /25
- •Refraction with a spherical equivalent less than 5 Dp.
- •Inform consent
排除标准
- •Cataract or other eye disease that may interfere with fundus examinations
- •Vitreous syneresis or posterior vitreous detachment
- •Other retinal vascular disease
- •Recent intraocular surgery
- •Previous laser therapy
- •Dilatation of the pupil < 5 mm
结局指标
主要结局
CSME needing Photocoagulation
时间窗: 24 months
次要结局
- Vision Loss(24 months)