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临床试验/NCT03903965
NCT03903965已完成不适用

Comparison of Retinal Perfusion Between Diabetic and Non-diabetic Patients With OCT Angiography After Cataract Surgery.

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
OCT Angiography parameters

研究概览

简要总结

This study aims to compare the retinal perfusion between diabetic and non-diabetic patients with Optical Coherence Tomography(OCT) Angiography after cataract surgery, to thoroughly evaluate the retinal state of diabetics after surgery, and to find out the relationship between postoperative complications occurred in retina and diabetes.

详细描述

In this study, we perform a completely comparison of retina state characteristic including the foveal avascular zone(FAZ),perifovea vessel density,parafovea vessel density,macular thickness,perifovea thickness,parafovea thickness in superficial and deep layers of retina with OCT Angiography after cataract surgery,and analysis on the differences of EGF,IFN-γ,IL-10,IL-12,IL-1β,IL-6,IL-8,IP-10,MCP-1,VEGF in aqueous humor before surgery between diabetic and non-diabetic patients and to explore the potential correlations between postoperative complications occurred in retina and diabetes.

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
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with age-related cataract and with willing to improve visual acuity by undergoing phacoemulsification and intraocular lens implantation surgery.
  • Type 2 diabetes diagnosis according to American Diabetes Association# Standards of Medical Care in Diabetes -2017(ADA, American Diabetes Association)
  • Willing to sign the consent form.

排除标准

  • having known maculopathy, proliferative diabetic retinopathy(PDR), diabetic macular edema.
  • with high myopia of spherical equivalent greater than -6.0 diopters or axial length (AXL) greater than 26 mm in either eye.
  • preexisting vein or artery occlusion,glaucoma, previous uveitis, a history of ocular trauma, laser treatment, intravitreal injections or intraocular surgeries.
  • patients who had complications during cataract surgery.
  • Elimination Criteria:
  • poor compliance
  • voluntary withdrawal
  • any other kind of situation that researchers consider not suitable for further study.

结局指标

主要结局

OCT Angiography parameters

时间窗: 3 months postoperatively

comparison of vessel density in superficial and deep layers of retina between diabetic and non-diabetic patients with OCT Angiography.

次要结局

  • aqueous humor cytokines levels(intraoperatively.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hong Qi

Principal Investigator

Peking University Third Hospital

研究点 (1)

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