Repeatability and Reproducibility of Corneal and Anterior Segment Measurements by ArcScan Insight 100 Very High-frequency Digital Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Repeatability of ArcScan Insight 100 corneal scans in normal eyes (standard deviation)
研究概览
简要总结
The purpose of this study is to evaluate the repeatability and reproducibility of corneal (including corneal, epithelial, stromal, and LASIK flap thickness) and anterior segment measurements using the ArcScan Insight 100 very high-frequency digital ultrasound arc-scanner.
详细描述
Very high-frequency (VHF) digital ultrasound was first used in 1993 to obtain images of the cornea (the window at the front of the eye) and anterior segment (the space behind the cornea including the iris and the lens). A commercially available instrument, called the Artemis 2, has been used in routine clinical practice since 2001. The Artemis 2 was CE approved as well as having FDA approval (the US equivalent of the CE mark).
The ArcScan Insight 100 VHF digital ultrasound scanner is a new instrument so does not yet have a CE mark. However, the ArcScan Insight 100 is an upgraded version of the Artemis 2, so any differences are improvements to components, but the measurement method remains essentially the same.
The aim of the study is to establish the repeatability (i.e. the variability in measurements taken by a single examiner during a single visit) and reproducibility (i.e. the variability in measurements taken in the same conditions between two examiners) of the ArcScan Insight 100 device for measuring corneal and anterior segment parameters.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Only patients who are medically suitable for corneal refractive surgery can be included in the study.
- •As general inclusion criteria the following aspects are defined:
- •Subjects should be 21 years of age or older.
- •Contact lens wearers must stop wearing their contact lenses at least four weeks per decade of wear before baseline measurements in case of hard contact lenses and one week before baseline measurements in case of soft contact lenses.
- •Patient will be able to understand the patient information and willing to sign an informed consent.
- •For the repeatability and reproducibility phase using normal eyes of the study:
- •Eyes with no ocular pathology
- •Eyes with no previous ocular or corneal surgery
- •For the repeatability and reproducibility phase using post-LASIK eyes of the study:
- •Eyes between 3 and 9 months after LASIK or SMILE
- •For the comparison of ArcScan Insight 100 VHF digital ultrasound with RTVue OCT
- •Either eyes before or after corneal refractive surgery
排除标准
- •Previous ocular or corneal surgery (for normal eyes)
- •Patient not being able to tolerate local or topical anesthesia
- •Patient has active conjunctivitis or any active ocular infection or inflammation
- •Patient has a corneal ulcer
- •Patient has an open wound on the corneal epithelium
- •Patient has compromised epithelium (e.g. ≥Grade 3 superficial punctate keratitis)
- •Pregnancy
研究组 & 干预措施
Repeatability and Reproducibility of ArcScan Insight 100
For repeatability and reproducibility in normal eyes (n=20):
Firstly, 5 consecutive repeated ArcScan Insight 100 scans of the cornea and anterior segment will be performed by the first operator.
After a break of about 30 minutes, 5 consecutive repeated ArcScan Insight 100 scans of the cornea and anterior segment will be performed by the second operator.
For repeatability and reproducibility in eyes after laser refractive surgery (n=20):
Firstly, 5 consecutive repeated ArcScan Insight 100 scans of the cornea will be performed by the first operator.
After a break of about 30 minutes, 5 consecutive repeated ArcScan Insight 100 scans of the cornea will be performed by the second operator.
干预措施: ArcScan Insight 100 very high-frequency digital ultrasound (Device)
结局指标
主要结局
Repeatability of ArcScan Insight 100 corneal scans in normal eyes (standard deviation)
时间窗: 1 day
The standard deviation of 5 repeated measurements for corneal thickness, epithelial thickness, and stromal thickness in normal eyes with no previous corneal surgery
次要结局
- Reproducibility of ArcScan Insight 100 corneal scans in normal eyes (between-operator standard deviation)(1 day)
- Repeatability of ArcScan Insight 100 anterior segment scans in normal eyes (standard deviation)(1 day)
- Reproducibility of ArcScan Insight 100 anterior segment scans in normal eyes (between-operator standard deviation)(1 day)
- Reproducibility of ArcScan Insight 100 corneal scans in eyes after corneal laser refractive surgery (between-operator standard deviation)(1 day)
- Repeatability of ArcScan Insight 100 corneal scans in eyes after corneal laser refractive surgery (standard deviation)(1 day)
研究者
Dan Reinstein
Medical Director
London Vision Clinic