跳至主要内容
临床试验/NCT00884637
NCT00884637已完成不适用

Correlation Between Visual Field Defects on Home Macular Perimeter (FORESEE HOME) and on OCT in Eyes of Patients With CNV Before and After Treatment

Notal Vision Ltd.1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Size and location of lesions

研究概览

简要总结

The FORESEE HOME is used in the recent years to detect Age-related Macular Degeneration (AMD) lesions. The device is capable of differentiation as to stages of AMD and early detection of changes including choroidal neovascularization (CNV) The Foresee HOME demonstrates a high level of sensitivity and specificity as to the different stages of AMD including newly diagnosed or early detection of CNV.

The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.

The FORESEE HOME can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Capable and willing to sign a consent form and participate in the study
  • Subjects diagnosed with CNV
  • Did not perform more then 4 anti- VGEF injections
  • VA with habitual correction better then 6/45 in the study eye
  • Ability to understand instructions
  • Familiar with computer usage

排除标准

  • Evidence of macular disease other than AMD or glaucoma in the study eye
  • Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy,
  • Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
  • Participation in another study with the exclusion of AREDS study

结局指标

主要结局

Size and location of lesions

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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