跳至主要内容
临床试验/NCT06287645
NCT06287645招募中不适用

Development of Digital Fundus Images Dataset of Local Population of Pakistan

Pakistan Council of Scientific and Industrial Research1 个研究点 分布在 1 个国家目标入组 50,000 人开始时间: 2022年5月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50,000
试验地点
1
主要终点
Grading Diabetic Retinopathy Severity according to Early Treatment of Diabetic Retinopathy Scale

研究概览

简要总结

This trial aims to provide a digital retinal image dataset from Pakistan, graded by three specialists according to the severity of Diabetic Retinopathy. The dataset aims to improve research and patient care.

详细描述

This clinical trial aims to address the scarcity of retinal image datasets in Pakistan by providing a comprehensive digital fundus photograph dataset, accompanied by expert grading. The dataset will encompass retinal images from Pakistani individuals, meticulously labeled by three Vitreo Retinal Specialists. These specialists will assess the presence and severity of common retinal disorders, including No Diabetic Retinopathy (No DR), Mild, Moderate, Severe, Proliferative Diabetic Retinopathy, Clinically Significant Macular Edema (CSME), and Advance diabetic Eye Diseases (ADED). Each image will also be evaluated for diagnostic clarity and the presence of any additional findings. Final grading decisions will be reached through unanimous consensus among the graders, ensuring the dataset's reliability and accuracy. This initiative holds promise for advancing ophthalmic research and improving patient care in Pakistan and beyond.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Type I or Type II Diabetes.
  • Patients of age of 20 years or above

排除标准

  • The participant is unable or unwilling to comply with study procedures.
  • Vulnerable participants (minors, legally detained individuals).
  • Prisoners or subjects who are involuntarily incarcerated.

结局指标

主要结局

Grading Diabetic Retinopathy Severity according to Early Treatment of Diabetic Retinopathy Scale

时间窗: 1 Visit (1 day)

Each Fundus photograph will be evaluated according to the Severity of Diabetic Retinopathy following Early Treatment of Diabetic Retinopathy Scale (ETDRS). Following Diabetic Retinopathy symptoms will be graded according to this scale. 1. Clinically Significant Macular Edema 2. Advance Diabetic Eye Disease

Grading Diabetic Retinopathy Severity according to International Clinical Diabetic Retinopathy Severity Scale

时间窗: 1 Visit (1 day)

Each Fundus photograph will be evaluated according to the Severity of Diabetic Retinopathy following International Clinical Diabetic Retinopathy Severity Scale (ICDRSS). Following Diabetic Retinopathy symptoms will be graded according to this scale. 1. No DR 2. Mild 3. Moderate 4. Severe 5. Proliferative

Finding inter-rater agreement among the graders

时间窗: Two Years

The intraclass correlation coefficient will be calculated using the collected dataset to assess the consistency in grading among all graders.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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