Comparison Between Retinal Images Captured by NOTAL-OCT V2.5 and Zeiss Cirrus / Heidelberg Spectralis SD OCT - Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 1
- 主要终点
- Comparison of presence/absence of fluid on OCT images from NOTAL-OCT v.2.5 device with a commercial OCT device, in AMD (Age-related Macular Degeneration) patients
研究概览
简要总结
Primary objective:
To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in AMD (Age-related Macular Degeneration) patients.
Secondary objectives:
- To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in DME (Diabetic Macular Edema) patients.
- To evaluate patient experience when self-operating the Notal-OCT V2.5.
详细描述
To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of AMD patients. OCT images from the central 10 degrees of the macula in AMD patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.
To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of DME patients. OCT images from the central 10 degrees of the macula in DME patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.
Patients will complete a questionnaire regarding the usability of the NOTAL-OCT v.2.5 device
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
- 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
- •Diagnosis of AMD (age-related macular degeneration) and/or DME (diabetic macular edema) in the study eye as confirmed by the investigator and recorded in the patient's clinical record
- •Ability to undergo OCT (optical coherence tomography) testing
- •Visual acuity of 20/400 Snellen (6/120) or better in the study eye
排除标准
- •Any ophthalmic or systemic condition that in the opinion of the investigator would preclude the patient from participating in the study.
结局指标
主要结局
Comparison of presence/absence of fluid on OCT images from NOTAL-OCT v.2.5 device with a commercial OCT device, in AMD (Age-related Macular Degeneration) patients
时间窗: less than an hour
To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of AMD patients. OCT images from the central 10 degrees of the macula in AMD patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.
次要结局
- Comparison of presence/absence of fluid on OCT images from NOTAL-OCT v.2.5 device with a commercial OCT device, in DR (Diabetic Retinopathy) patients(less then an hour)
- Patient experience using the NOTAL-OCT v.2.5 device(less than an hour)