Annotation of Geographic Atrophy in Hyperspectral Images Captured With the Optina-4C™
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Comparison of the total number of Relspec images annotated for GA lesions
研究概览
简要总结
This study used a retrospective dataset collected by Optina under different study protocols. The target study population will include adults over the age of 50 years, with and without the presence of AMD.
详细描述
This retrospective, case-control study used the clinical data previously collected by Optina (CIP 22-003 AND Study, CIP 22-004 CAS Training Study and RWD 24-011 RWD Study). As such, no new participants were enrolled for this study. The review and annotation of the MHRC H5 Images for GA are within the scope of each of these studies and the study participants have provided their Informed Consent for use of their retinal scans to assess clinical diagnostic applications. Images from the above-mentioned studies that met the inclusion criteria (there were no exclusion criteria) were classified into 3 different cohorts per the selection process described in the Study Protocol. Each cohort required a minimum of 10 MHRC Images from unique eyes with matched OCT scans.
- Cohort A: Eyes of patients with a diagnosis of dry AMD with GA lesions:
o This cohort included patients with intermediate-or late-stage dry AMD where GA lesions are present, based on either the diagnostic information provided by the clinic, or by visible assessment of either the HSI or OCT images performed by the Optina Analyst.
- Cohort B: Eyes of patients with diagnosis of dry AMD without the presence of GA lesions
o This cohort included patients with early or intermediate dry AMD where GA lesions are not present, based on either the diagnostic information provided by the clinic, or by visible assessment of either the HSI or OCT images performed by the Optina Analyst.
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Cohort C: Eyes of age-matched healthy patients (no AMD or GA lesions)
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This cohort included patients with healthy retinas, based on either the diagnostic information provided by the clinic, or by visible assessment of either the HSI or OCT images performed by the Optina Analyst. Knowledge Transfer and Training Optina facilitated a Knowledge Transfer and Training session by the IOI for CapeStart Study Personnel.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants may enter the study only if ALL the following inclusion criteria are present:
- •Study participants over the age of 50 years who consented to participate in Optina studies CIP-22-003, CIP-22-004, DOC100463, or RWD-24-
- •MHRC H5 Image Cube has been reviewed by an Optina Analyst and identified as aligned with the Target Population (see Section 5.2).
- •MHRC H5 Image Cube has a corresponding OCT image.
排除标准
- •No exclusion criteria.
结局指标
主要结局
Comparison of the total number of Relspec images annotated for GA lesions
时间窗: 45 days
Comparison of the total number of Relspec images annotated for GA lesions of at least 29 pixels or larger with the total number of OCT images with identified GA lesions (cRORA) in the Test Dataset.
Comparison of the total number of 'high certainty' GA lesions
时间窗: 45 days
Comparison of the total number of 'high certainty' GA lesions (Yellow label) of at least 29 pixels annotated in all Relspec images with the total number of (cRORA) identified in the OCT images in the Test Dataset.
Comparison of the total number of GA lesions
时间窗: 45 days
Comparison of the total number of GA lesions (Yellow label and Dark Blue label) of at least 29 pixels or larger annotated in all Relspec images with the total number of identified GA lesions (cRORA) in the OCT images in the Test Dataset.
Evaluation of the Global DICE Score
时间窗: 45 days
Evaluation of the Global DICE Score for annotations of 29 pixels or larger performed by CapeStart compared with the Reference Data.
次要结局
未报告次要终点