跳至主要内容
临床试验/NCT06436170
NCT06436170已完成不适用

Radial Peripapillary Vessel Density as a New Biomarker in Irvine-Gass Syndrome

Federico II University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
the role of OCTA in diagnosis of IGS

研究概览

简要总结

Pseudophakic cystoid macular edema (PCME), also known as Irvine-Gass syndrome (IGS), is an accumulation of fluid in the macula that occurs after cataract surgery, with an early or late presentation (cut-off 3 months) . It is the most common cause of decreased vision after uneventful phacoemulsification, with a rare incidence of 0.1-2.35% for clinically significant PCME .

Macular edema in IGS can be diagnosed and classified by optical coherence tomography (OCT), which enables its morphologic assessment. Fluorescein angiography (FA) is the gold standard to perform differential diagnosis for macular edema.

To date, OCT angiography (OCTA) has been proposed to study various retinal vascular diseases. In contrast to FA, OCTA is able to visualize Radial peripapillary vessel density (RCP).

The aim of this study was to investigate abnormalities in the vascular network of the optic nerve head in patients with IGS compared to healthy eyes, using OCT-A

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
58 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of PCME Cataract surgery

排除标准

  • diabetes vein occlusion uveitis vasculitis age-related macular degeneration hereditary macular dystrophy

结局指标

主要结局

the role of OCTA in diagnosis of IGS

时间窗: 10 months

To evaluate the vascolarization of RPC in IGS

次要结局

未报告次要终点

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gilda Cennamo

Principal Investigator

Federico II University

研究点 (1)

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