NCT07680244招募中不适用
(CIRRUS-2023-1) CLINICAL CLIN Assessment of PathFinder 1.0 on the CIRRUS 6000 and the CIRRUS 5000
Carl Zeiss Meditec-Dublin CoCe6 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年5月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 6
- 主要终点
- Sensitivity of PathFinder 1.0
研究概览
简要总结
This study will measure how well PathFinder 1.0 detects retinal abnormalities on macular cube OCT B-scans by assessing its sensitivity and specificity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- 是
入选标准
- •Able and willing to make the required study visits.
- •Able and willing to give written informed consent and follow study instructions.
- •Able and willing to complete ophthalmic imaging.
- •Adults 18 years of age or older.
- •The subject population will be comprised of two groups (all categories below pertain to the central 6x6 mm macula area):
- •1. Subjects with absence of macular abnormalities Group B
- •Subjects with Disruption of the vitreoretinal interface (VRI)
- •Subjects with Intraretinal hyporeflective space (IRHS)
- •Subjects with Subretinal hyporeflective space (SRHS)
- •Subjects with IS/OS (Ellipsoid Zone) disruption
- •Subjects with Retinal Pigment Epithelium (RPE) elevation
- •Subjects with Retinal Pigment Epithelium (RPE) atrophy
- •Other abnormalities
排除标准
- •Inability to undergo the required tests.
- •Unable to give consent or follow study instructions.
- •Inability to fixate that precludes obtaining acceptable macula scans in the study eye.
- •Visudyne (verteporfin) injection within the last 48 hours in the study eye.
- •Pilocarpine or Vuity use within the last 24 hours in the study eye.
- •Dense media opacity precluding adequate visualization of the retina in the study eye.
- •Vitreous floaters that preclude obtaining acceptable scans in the study eye.
研究组 & 干预措施
Subjects with absence of macular abnormalities
Other
Subjects with absence of macular abnormalities
干预措施: PathFinder 1.0 on CIRRUS HD-OCT (Device)
Subjects with presence of macular abnormalities
Other
Subjects with presence of macular abnormalities
干预措施: PathFinder 1.0 on CIRRUS HD-OCT (Device)
结局指标
主要结局
Sensitivity of PathFinder 1.0
时间窗: Baseline (single study visit OCT acquisition)
Sensitivity is the proportion of scans that PathFinder 1.0 correctly identifies as having any macular abnormality.
Specificity of PathFinder 1.0
时间窗: Baseline (single study visit OCT acquisition)
Specificity is the proportion of scans that PathFinder 1.0 correctly identifies as having no macular abnormality.
次要结局
- Sensitivity and specificity by clinical diagnosis(Baseline)
- Sensitivity by macular abnormality type(Baseline)
- Positive Predictive Value and Negative Predictive Value(Baseline)
- Rate of acceptable versus unacceptable B-scans(Baseline)
- Algorithm repeatability (precision)(Baseline)
研究者
研究点 (6)
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