AONDA Retrospective Study 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- Incidence of Microbial Keratitis up to Year 1 - CW Cohort
研究概览
简要总结
The purpose of this study is to assess long term performance and safety of AONDA in a real world setting when worn as daily wear or continuous wear for vision correction. This study will be used to support AONDA's marketability in Europe and other locations.
详细描述
In this retrospective observational study, the subject used AONDA for at least approximately 1 year in either a daily wear (DW) or continuous wear (CW) modality with monthly replacement. For the CW cohort only, 3-year data will be collected, if available.
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
- •Normal eyes, as determined or known by the investigator;
- •Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline;
- •Best Corrected Visual Acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;
- •At the time of the 1-year visit, subject was prescribed and wearing AONDA in both eyes in either a DW or CW modality for at least approximately 1 without changing modality;
- •Baseline and 1-year visit chart available;
- •Other protocol-specified inclusion criteria may apply.
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;
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Incidence of Microbial Keratitis up to Year 1 - CW Cohort
时间窗: Up to Year 1
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Incidence of Corneal Infiltrative Events up to Year 1 - DW Cohort
时间窗: Up to Year 1
The subject's chart will be reviewed for corneal infiltrative adverse events occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Incidence of Microbial Keratitis up to Year 3 - CW Cohort
时间窗: Up to Year 3
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Distance Visual Acuity at Year 3 - CW Cohort
时间窗: Year 3
The subject's chart will be reviewed for a distance visual acuity assessment at 3 years after the baseline exam. The 3-year visit will be defined as a visit which occurred 3 years (-2/+8 months) since baseline, during which period the subject was wearing AONDA and a contact lens examination was performed. The 3-year visit will be applicable only if the chart indicates the subject was wearing AONDA since baseline and 1-year.
Incidence of Corneal Infiltrative Events up to Year 1 - CW Cohort
时间窗: Up to Year 1
The subject's chart will be reviewed for corneal infiltrative adverse events occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Incidence of Microbial Keratitis up to Year 1 - DW Cohort
时间窗: Up to Year 1
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Distance visual acuity at Year 1 - DW Cohort
时间窗: Year 1
The subject's chart will be reviewed for a distance visual acuity assessment at 1 year after the baseline exam. The 1-year visit will be defined as a visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing AONDA, and a contact lens examination was performed. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Distance Visual Acuity at Year 1 - CW Cohort
时间窗: Year 1
The subject's chart will be reviewed for a distance visual acuity assessment at 1 year after the baseline exam. The 1-year visit will be defined as a visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing AONDA, and a contact lens examination was performed. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
Incidence of Corneal Infiltrative Events Up to Year 3 - CW Cohort
时间窗: Up to Year 3
The subject's chart will be reviewed for corneal infiltrative adverse events occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.
次要结局
未报告次要终点