Comparative Study of the Cornea/Anterior Segment OCT CASIA2 and the RTVue XR OCT Avanti With AngioVue Software
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Agreement of Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
研究概览
简要总结
This study is a prospective comparative, randomized, single center study to gather agreement and precision data in all subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal Group:
- •Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
- •Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
- •Subjects who agree to participate in the study;
排除标准
- •Normal Group:
- •Subjects unable to tolerate ophthalmic imaging;
- •Subjects with any current ocular pathology, as determined by self-report and confirmed by the investigator assessment and/or confirmed by the investigator assessment at the study visit;
- •Subjects that present with an active ocular infection in either eye;
- •Subjects who have a history of ocular surgery, including laser therapy/surgery;
- •Subjects with a condition or in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
- •Inclusion Criteria - Cataract Group:
- •Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
- •Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
- •Subjects who agree to participate in the study;
- •Subjects diagnosed with cataract classified per the LOCS III scale;
- •Exclusion Criteria - Cataract Group:
- •Subjects unable to tolerate ophthalmic imaging;
- •Subjects with corneal or conjunctival abnormalities that may affect adequate assessment of the anterior chamber in either eye;
- •Subjects that present with an active ocular infection in either eye;
- •Subjects who have a history of ocular surgery, including laser therapy/surgery;
- •Subjects with a condition or in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- •Inclusion Criteria - Glaucoma Group:
- •Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
- •Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
- •Subjects who agree to participate in the study;
- •Subjects with glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
- •Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage;
- •Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
- •History of Visual field defects within the previous six (6) months from the study visit or measured the day of the study visit consistent with glaucomatous optic nerve damage with at least one of the following two findings:
- •On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;
- •Glaucoma hemi-field test "outside normal limits."
- •Exclusion Criteria - Glaucoma Group:
- •Subjects unable to tolerate ophthalmic imaging;
- •Subjects with corneal or conjunctival abnormalities that may affect adequate assessment of the anterior chamber in either eye;
- •Subjects that present with an active ocular infection in either eye;
- •No reliable Humphrey Field Analyzer (HFA) visual field (24-2 Sita Standard, white on white) result within 6 months of the study visit, defined as fixation losses > 33% or false positives > 33%, or false negatives > 33% in the study eye;
- •Subjects with a condition or in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
研究组 & 干预措施
Cataract
干预措施: Cornea/Anterior Segment OCT CASIA2 (Device)
Cataract
干预措施: Optovue RTVue XR Avanti (Device)
Normal
干预措施: Cornea/Anterior Segment OCT CASIA2 (Device)
Normal
干预措施: Optovue RTVue XR Avanti (Device)
Glaucoma
干预措施: Cornea/Anterior Segment OCT CASIA2 (Device)
Glaucoma
干预措施: Optovue RTVue XR Avanti (Device)
结局指标
主要结局
Agreement of Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
时间窗: Up to 30 days
Angle-Opening Distance Angle-Opening Distance
Agreement of Corneal thickness (μm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
时间窗: Up to 30 days
Thickness of Cornea
Agreement of OCT image quality for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT and evaluation of visibility of predefined anatomical structures
时间窗: Up to 30 days
Precision of the Corneal thickness (μm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
时间窗: Up to 30 days
Corneal thickness
Precision of the Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
时间窗: Up to 30 days
Angle-Opening Distance
Precision of the Ks (steep meridian) measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
时间窗: Up to 30 days
Ks (steep meridian)
Agreement of Trabecular-Iris Space Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
时间窗: Up to 30 days
Trabecular-Iris Space Area
Precision of the Anterior Corneal Depth measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
时间窗: Up to 30 days
Anterior Corneal Depth
Precision of the Pupil Diameter measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
时间窗: Up to 30 days
Pupil Diameter
Precision of the Average Keratometry measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
时间窗: Up to 30 days
Average Keratometry
Precision of the Angle Recess Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
时间窗: Up to 30 days
Angle Recess Area
Precision of the Kf (flat meridian) measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
时间窗: Up to 30 days
Kf (flat meridian)
Precision of the Anterior Corneal Width measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
时间窗: Up to 30 days
Anterior Corneal Width
Precision of the Trabecular-Iris Angle measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
时间窗: Up to 30 days
Trabecular-Iris Angle
Precision of the Trabecular-Iris Space Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
时间窗: Up to 30 days
Trabecular-Iris Space Area
Precision of the Corneal Cylinder measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
时间窗: Up to 30 days
Corneal Cylinder
次要结局
- Adverse Events(Up to 30 days)