跳至主要内容
临床试验/CTRI/2012/01/002317
CTRI/2012/01/002317已完成不适用

A Prospective evaluation of the eye and systemic conditions in self reported diabetics in a tertiary eye institute located in Eastern India

LVPrasad Eye Institute1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年1月11日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
1.presence in level of Diabetic retinopathy

研究概览

简要总结

the step 1 was the general examination at the entry point of the study.This included a detailed eye examination,anthropometry,blood biochemistry and the Knowledge,Attitude and Practice(KAP) level.The eye examination included a detailed personal and family history,visual acuity measurement using illuminated ETDRS chart placed at 4 meter distance,refraction,Goldmann applanation pressure,gonioscopy when necessary,dilated fundus examination and color fundus photography using 3 Nethra fundus camera.The blood biochemistry included lipid profile,renal profile,HbA1C and hemoglobin level.KAP questionnaire was administered to all the study patients.

The step II was the specific diabetic retinopathy(DR) related investigation.It was done in patients who were detected to have any stage of diabetic retinopathy clinically.This included fluorescein angiography and optical coherence tomography.The National Eye Institute Vision Function Questionnaire 25(NEI VFQ 25) was administered to all study patients who entered the stage II of the study.

The step III was the specific treatment of patients with Diabetic Retinopathy.This essentially consisted of one of the three or combination of retinal laser,intravitreal anti-vascular endothelial growth factor(VEGF) injection and vitrectomy.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • 1.Known Type-2 Diabetis mellitus 2.willing to sign informed consent form.

排除标准

  • 1.Non-Diabetic 2.Not willing to sign informed consent form.

结局指标

主要结局

1.presence in level of Diabetic retinopathy

时间窗: 2 Months

2.co-existing systemic conditions other than diabetic condition

时间窗: 2 Months

3.Knowledge,attitude and practice in patients with DM.

时间窗: 2 Months

4.Quality of life in patients with Diabetic retinopathy.

时间窗: 2 Months

次要结局

  • Not applicable(Not applicable)

研究者

发起方
LVPrasad Eye Institute
申办方类型
Private hospital/clinic

研究点 (1)

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