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临床试验/NCT06269419
NCT06269419招募中不适用

Observational Cohort Study of Natural Course Progression of Diabetic Retinopathy

Jie Li1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年2月25日最近更新:
适应症

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

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

发起方
Jie Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jie Li

associate chief physician

Sichuan Provincial People's Hospital

研究点 (1)

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