Post-Market Clinical Survey of Clareon® IOL With the AutonoMe™ Automated Preloaded Delivery System With Japanese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Difference between target refraction and postoperative subjective refraction (spherical equivalent)
研究概览
简要总结
This purpose of this survey study is to collect and describe clinical outcomes for the intraocular lens (IOL) delivery performance of Clareon® IOL AutonoMe™ when used in daily practice.
详细描述
This study will enroll subjects who underwent prior cataract surgery with phacoemulsification and were implanted with Clareon intraocular lenses (IOLs) using the Clareon® IOL AutonoMe™ automated preloaded delivery system. Subjects will be enrolled post-operatively and followed for one year.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to comprehend and willing to sign informed consent.
- •Prior diagnosis of age-related cataracts.
- •Prior cataract surgery with implantation of Clareon IOL in the capsular bag by AutonoMe™.
- •No ophthalmic disease which might affect visual acuity.
排除标准
- 未提供
结局指标
主要结局
Difference between target refraction and postoperative subjective refraction (spherical equivalent)
时间窗: Up to Year 1 postoperative
Visual acuity will be collected under well-lit conditions at a distance of five meters using a decimal visual acuity chart. Subjective refraction at best corrected distance vision will be recorded and compared with target refraction determined on day of surgery.
Best-corrected distance visual acuity
时间窗: Up to Year 1 postoperative
Visual acuity will be collected under well-lit conditions at a distance of five meters using a decimal visual acuity chart.
Intraocular lens (IOL) delivery performance
时间窗: Surgery day (retrospective)
A questionnaire will be used to retrospectively evaluate the usability of AutonoME™. The investigator will respond to 8 questions pertaining to the IOL delivery performance using a 5-point scale where 1 = very good/strongly agree and 5 = very poor/strongly disagree.
次要结局
未报告次要终点