Home Retinal Imaging Using NOTAL-OCT V3.0
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To describe the dynamics of retinal fluid
研究概览
简要总结
The study will include up to 30 AMD patients, recruited by two medical centers, Tel-Aviv medical center and Assuta Hashalom medical center. At the screening visit, the patients will be imaged in their tested, eligible eye(s), using a commercial Zeiss Cirrus or Heidelberg Spectralis OCT.
详细描述
Screening visit:
For patients eligible to participate in the study, the following procedure will be done in the "screening visit" at the clinic:
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Patient will sign the IC (Informed Consent) form
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The following demographic and clinical data will be collected and registered in the CRF:
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Patient's DOB and gender.
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Patient's diagnosis in study eye(s), based on patient's medical record, including media opacity (e.g. cataract or corneal opacity, if exists).
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Bio-microscopy testing.
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Refraction correction by an optometrist.
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Habitual Snellen visual acuity
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Commercial OCT scanning using Zeiss Cirrus or Heidelberg Spectralis.
OCT scanning pattern:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability and willingness to give informed consent (IC)
- •18 years of age or older at the time of IC
- •Tested eye(s) diagnosed with AMD
- •Visual acuity of 20/400 Snellen (6/120) or better in the study eye
- •At least one eye is with active CNV, presenting retinal fluid at the enrolment visit, undergoing active anti-VEGF treatment
- •Ability to undergo OCT testing
排除标准
- 未提供
结局指标
主要结局
To describe the dynamics of retinal fluid
时间窗: 30 days
To describe the dynamics of retinal fluid in eyes undergoing anti-VEGF therapy as manifested in self-operated OCT in daily home testing
次要结局
- To evaluate patient experience when self-operating the Notal-OCT V3.0.(30 days)
- E. To evaluate the level of agreement between OCT images captured by Notal-OCT V3.0 and a commercial OCT(30 days)