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
- 58
- 试验地点
- 2
- 主要终点
- To evaluate the level of agreement between OCT images captured by NOTAL-OCT V3.0 and by a commercial OCT
研究概览
简要总结
The study will include up to 250 AMD patients and up to 30 DR patients. In Tel Aviv medical center up to 100 AMD/ 20 DR patients will be recruited; In Assuta HaShalom up to 100 AMD/10 DR patients will be recruited; In Bnei Zion medical center up to 50 AMD patients will be recruited.
4.1 Study population 1. AMD patients - intermediate and advanced AMD (with active or non-active CNV) 2. DR patients - with and without edema 4.2 Inclusion criteria
- Ability and agreement to give informed consent (IC)
- Diagnosis of AMD or DR in SE by OCT
- Ability to undergo OCT scans
- VA of 20/400 (6/120) or better in study eye(s)
4.3 Exclusion criteria
- Patient with dilated eye(s)
详细描述
4.5.1 SCREENING VISIT:
For patients eligible to participate in the study, the following procedure will be done in the screening visit:
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Patient will sign the IC (Informed Consent) form
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Test the eligible eye(s) of the patient will be tested
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The following demographic and clinical data will be collected for each tested eye and will be 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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Examination to check habitual correction, pinhole VA and refraction.
4.5.2 OCT Visit 1: may take place on the same day as screening visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 agreement to give informed consent (IC)
- •Diagnosis of AMD or DR in SE by OCT
- •Ability to undergo OCT scans
- •VA of 20/400 (6/120) or better in study eye(s)
排除标准
- •Patient with dilated eye(s)
结局指标
主要结局
To evaluate the level of agreement between OCT images captured by NOTAL-OCT V3.0 and by a commercial OCT
时间窗: Less then an hour
The measurement of fluid as identified by an eye-care professional, in the central 10 degrees of the macula of DR patients.
次要结局
- To evaluate the level of agreement between OCT images captured by NOTAL-OCT V3.0 and a by commercial OCT(Less then an hour)
- To evaluate the level of agreement between NOTAL-OCT V3.0 and a commercial OCT in the presence of fluid(Less then an hour)
- To evaluate repeatability(Less then an hour)