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临床试验/NCT01771939
NCT01771939已完成不适用

Morphologic and Functional Results After Phacoemulsification and 25 Gauge Vitrectomy Versus Phacoemulsification Only in Eyes Affected by Idiopathic Epiretinal Membranes

University of Turin, Italy2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年10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
60
试验地点
2
主要终点
Visual acuity (using LogMar scale) changes from baseline to pre-defined periods after surgery

研究概览

简要总结

The purpose of the study is to evaluate the difference in Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, oct retinal thickness and microperimetry in 2 groups of 30 eyes each affected by idiopathic epiretinal membranes that underwent phacoemulsification and 25G pars-plana vitrectomy with internal limiting membrane (ILM) peeling (Group 1) versus phacoemulsification only (Group 2), with a follow-up length up to 5 years.

详细描述

Idiopathic epiretinal membranes represent a common cause of visual loss in elderly population. Vitrectomy with membrane peeling is nowadays considered the gold standard in the management of such pathology, with very good results either at short-time or at long-time follow up. In case of mild visual impairment due to epiretinal membrane and associated cataract, it is reasonable to treat only the lens pathology (with phacoemulsification and intra-ocular lens (IOL) implantation). In case of symptoms or ophthalmoscopic finding worsening it is always possible to submit patients who only underwent cataract surgery to vitrectomy with membrane peeling. There are, by now, no comparative studies between these two different approaches in medical literature.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Idiopathic epiretinal membranes symptomatic

排除标准

  • Absence of ocular symptoms, previous retinal interventions

结局指标

主要结局

Visual acuity (using LogMar scale) changes from baseline to pre-defined periods after surgery

时间窗: within 90,180,360,1360 days after surgery

We observed how did the visual acuity (using LogMar scale) increase after the two different surgical approaches described.

次要结局

  • Microperimetry parameters and average macular thickness changes(within 90,180,360,1360 days after surgery)

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Dal Vecchio

MD

University of Turin, Italy

研究点 (2)

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