Air Optix® Night and Day® Aqua Continuous Wear
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,140
- 试验地点
- 8
- 主要终点
- Distance visual acuity
研究概览
简要总结
The purpose of this retrospective, Post-Market Clinical Follow-Up (PMCF) study is to assess the long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as 30 days of continuous wear for vision correction.
详细描述
This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify charts within their existing databases in a fair and consistent manner. Subjects/charts meeting the eligibility criteria will be enrolled in the study.
The study is designed with one period. The duration of the period includes the Baseline Visit and the Year 3 Visit as follows:
- The Baseline Visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject, before or during which a contact lens prescription for AONDA or PureVision 2 (PV2) was released.
- The Year 3 Visit is defined as a visit which occurred 3 years (-2/+8 months) since Baseline during which period the subject was wearing AONDA contact lenses or PV2 contact lenses and a contact lens examination was performed.
The data collection period is defined as any approximately 3-year timeframe since and including 2009.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Manifest refraction cylinder less than or equal to 0.75 diopter in each eye at baseline
- •Best corrected visual acuity of 20/25 or better in each eye at baseline
- •At the time of Year 3 Visit, subject was prescribed and wearing AONDA or PV2 contact lenses in both eyes in a 30-day continuous wear modality for at least approximately 3 years
- •Baseline Visit and Year 3 Visit charts available
排除标准
- •Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at baseline
- •The use of systemic or ocular medications contraindicating regular contact lens wear at baseline
- •History of refractive surgery or irregular cornea
- •Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear at baseline
结局指标
主要结局
Distance visual acuity
时间窗: Year 3
The subject's chart will be reviewed for distance visual acuity.
Incidence of corneal infiltrative events
时间窗: Up to Year 3
The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the Baseline Visit exam.
Incidence of microbial keratitis
时间窗: Up to Year 3
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the Baseline Visit exam.
次要结局
未报告次要终点