Comparison Between Home Macular Perimeter and OCT Visual Field Defects in Patients With CNV
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Investigate the correlation between features of CNV lesions as measured with SD OCT and in the ForeseeHome.
研究概览
简要总结
The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with Age Related Macular Degeneration (AMD). However, the device has the ability to detect the development of the lesion post treatment and therefore to assess in determination of the next treatment.
The Optical Coherence Tomography (OCT) may be used as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.
The FORESEE HOME can be used as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluating 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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For naïve CNV lesion - diagnosed in less than 60 days. OR For re-activated CNV lesion - treated more than 4 month from the diagnosis.
- •Intent to treat the study eye (SE)
- •Corrected VA better than 6/45 (20/150) in SE
- •Subject is capable and willing to sign a consent form and participate in the study
- •Age > 55 years
- •Subject declared that he or she knows how to operate a computer mouse
排除标准
- •Evidence of macular disease other than AMD or glaucoma in SE
- •Presence of any significant media opacity that precludes a clear view of the macular area as identified in the SE by biomicroscopy
- •Any ocular surgery performed within 3 months prior to study entry in the SE * Participation in another study
结局指标
主要结局
Investigate the correlation between features of CNV lesions as measured with SD OCT and in the ForeseeHome.
时间窗: 3-4 months
the measures are Height of Pigment Epithelial Detachment , Sub Retinal Fluid Thickness , Maximum Diameter of Largest Retinal Cyst , Maximum Retinal Thickness , Central Retinal Thickness
次要结局
未报告次要终点