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临床试验/NCT01254006
NCT01254006已完成不适用

Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients

University of Roma La Sapienza1 个研究点 分布在 1 个国家开始时间: 2010年12月6日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
试验地点
1
主要终点
retinal nerve fibres layer thickness

研究概览

简要总结

In this study the investigators are going to study the retinal nerve fibers layers (RNFL) modification of two groups of patients, one taking no drugs, the other taking forskolin, rutin and vitamins B1 and B2.

研究设计

研究类型
Interventional

入排标准

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

入选标准

  • Age (30-80 years);
  • Baseline Intraocular pressure (IOP) (20-32 mmHg): average untreated Intra Ocular Pressure (IOP) for both eyes as determined from 2 to 4 visits within a 6-months period;
  • Central Corneal Thickness (CCT) (475-650 µm): average of 3 different measurements from both eyes during the same visit;
  • Pattern standard deviation (PSD) (0,50-3,00 dB) average of both eyes as stated on the most recent visual field index report
  • Vertical Cup/Disk ratio (0,00-0,80): average of both eyes
  • All these data were entered into a calculator specially designed for STAR (Scoring Tool for assessing risk) II parameter. The patients were divided into low-, moderate- and high risk groups according to the result given by the calculator.

排除标准

  • other ocular pathologies than glaucoma

结局指标

主要结局

retinal nerve fibres layer thickness

次要结局

  • global risk threshold for glaucoma progression

研究者

发起方
University of Roma La Sapienza
申办方类型
Other

研究点 (1)

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