Agreement of Two OCT Biometers: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Regression-Based Axial Length (R-AL)
研究概览
简要总结
The purpose of this study is to compare the measurements obtained with two different biometers, UNITY Dx and Anterion. In eye care, a biometer is a device that uses laser technology to take highly precise measurements of the eye's internal structures. It is most frequently used to help determine the exact power of the intraocular lens (IOL) needed before cataract removal.
详细描述
The study population will consist of male and female adult subjects with a normal cornea (up to 10 subjects), keratoconus (up to 10 subjects), prior corneal laser vision correction (up to 10 subjects), current and habitual contact lens wear (up to 10 subjects), or dry eye (up to 10 subjects). In this single visit study, subjects will have data collected on one eye (unilateral) only. If both eyes meet the entry criteria, the right eye will be designated as the study eye.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have healthy, clear corneas for the normal cohort;
- •Have documented keratoconus for the keratoconus cohort;
- •Have reported use of daily contact lens use for the contact lens cohort;
- •Have documented dry eye, consisting of signs and symptoms for the dry eye cohort;
- •Has had previous keratorefractive surgery for the post-refractive surgery cohort;
- •Able to comprehend and sign the informed consent form.
排除标准
- •Active ocular infection or inflammation;
- •Unable to fixate due to nystagmus or other eye movement abnormality (e.g., significant strabismus);
- •Any ocular disease and/or condition that, in the investigator's clinical judgment, may put the subject at significant risk, may compromise study result or may interfere significantly with the subject's participation in the study.
研究组 & 干预措施
Normal Corneas
This cohort will enroll subjects with normal corneas.
干预措施: UNITY DX (Device)
Normal Corneas
This cohort will enroll subjects with normal corneas.
干预措施: ANTERION (Device)
Keratoconus
This cohort will enroll subjects with keratoconus.
干预措施: UNITY DX (Device)
Keratoconus
This cohort will enroll subjects with keratoconus.
干预措施: ANTERION (Device)
Prior Corneal Laser Vision Correction
This cohort will enroll subjects with prior corneal laser vision correction.
干预措施: UNITY DX (Device)
Prior Corneal Laser Vision Correction
This cohort will enroll subjects with prior corneal laser vision correction.
干预措施: ANTERION (Device)
Current and Habitual Contact Lens Wear
This cohort will enroll subjects with current and habitual contact lens wear.
干预措施: UNITY DX (Device)
Current and Habitual Contact Lens Wear
This cohort will enroll subjects with current and habitual contact lens wear.
干预措施: ANTERION (Device)
Dry Eye
This cohort will enroll subjects with dry eye.
干预措施: UNITY DX (Device)
Dry Eye
This cohort will enroll subjects with dry eye.
干预措施: ANTERION (Device)
结局指标
主要结局
Regression-Based Axial Length (R-AL)
时间窗: Day 1
Regression-based Axial Length (R-AL) is the distance from the anterior surface of the cornea to the retina at the back of the eye, measured along the visual axis. R-AL will be measured by the device and reported in microns.
次要结局
未报告次要终点