Observational Cohort Study of Natural Course Progression of Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Urinary creatinine ACR
研究概览
简要总结
The goal of this observational study is to observe the formation and development of the non-perfusion area of diabetic retinopathy in the posterior area of the retina in type 2 diabetes patients aged 18-75 years old, who can cooperate with all examinations and sign informed consent, clinical myopathy examination and Optos 7 field of vision with mild than severe NPDR, and no other exclusion indicators.The main questions it aims to answer are whether posterior retinal non-perfusion area occurs earlier than peripheral non-perfusion area and whether the rate of non-perfusion area expansion is a risk factor for the progression of diabetic retinopathy.
Participants will have protocol-specific follow-up examinations at 1, 2, 3, 4, and 5 years (± 3 months). Additional visits are made as required by the study and the patient's condition.
The contents of follow-up examinations are:
History of other diseases, medications being used, eye diseases, surgeries, treatments, height, weight, and blood pressure.
Best corrected vision, logarithmic visual acuity chart. Tupai OCTA, 24×20mm range, 6×6mm range scan. Optos fundus imaging, color and no red light images. Fundus fluorescence angiography (only preliminary examination for the first time found mild to moderate NPDR patients, who have been angiographed in the past, only at the 5th year, or as required by the condition).
Glycosylated hemoglobin. Creatinine, urea, glomerular filtration rate. Total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol.
Urinary microalbumin/urinary creatinine ACR. Microvisual field.
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
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Urinary creatinine ACR
时间窗: 2024-2029
tested by urine
Glomerular filtration rate
时间窗: 2024-2029
tested by venous blood
Level of Glycosylated hemoglobin
时间窗: 2024-2029
tested by venous blood
Creatinine
时间窗: 2024-2029
tested by venous blood
Total cholesterol
时间窗: 2024-2029
tested by venous blood
Urinary microalbumin
时间窗: 2024-2029
tested by urine
Urea
时间窗: 2024-2029
tested by venous blood
Triglycerides
时间窗: 2024-2029
tested by venous blood
Low-density lipoprotein cholesterol
时间窗: 2024-2029
tested by venous blood
High-density lipoprotein cholesterol
时间窗: 2024-2029
tested by venous blood
Observation and follow-up of biomarkers of diabetic retinopathy
时间窗: 2024-2029
The biomarkers of diabetic retinopathy were observed by eye examinations including best corrected visual acuity, logarithmic visual acuity chart, TupaOCTA 24×20mm, 6×6mm scan, Optos fundus color and non-red light images, microvisual field at each follow-up.
次要结局
未报告次要终点
研究者
Jie Li
associate chief physician
Sichuan Provincial People's Hospital
