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临床试验/NCT00840541
NCT00840541已完成不适用

Observational Study of Type-2 Diabetic Subjects to Validate Diabetic Retinopathy Phenotypes

Association for Innovation and Biomedical Research on Light and Image1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
CSME

研究概览

简要总结

The purpose of this study is to validate and characterize phenotypes of diabetic retinopathy (DR) progression based on available clinical data (demographic, systemic and ophthalmic data).

详细描述

This study aims to validate and characterize phenotypes of diabetic retinopathy (DR) progression using ophthalmic and systemic data from type-2 diabetic subjects followed at the AIBILI Clinical Trial Center in the last 10 years.

Macular Edema (ME) development during the study period, mainly Clinically Significant ME (CSME) needing treatment, will be the primary indicator for DR progression. CSME will be considered as the primary end-point and will be used to identify phenotypes (and risk markers) of DR progression.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Diagnosis of DR.
  • Females or Males;
  • Age over 18 years;
  • Signed Informed Consent;
  • Previous follow-up with regular systemic and ophthalmic assessments.

排除标准

  • Cataract or other eye disease that may interfere with fundus examinations;
  • Vitreous syneresis or posterior vitreous detachment;
  • Dilatation of the pupil < 5 mm.

结局指标

主要结局

CSME

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
Association for Innovation and Biomedical Research on Light and Image
申办方类型
Other
责任方
Sponsor

研究点 (1)

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