Safety and Efficacy of the Hydrophobic Intraocular Lens Asqelio Monofocal With Biaspheric Design
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
The goal of this observational study is to learn about the Asqelio monofocal intraocular lens (IOL) model QLIO130C in patients undergoing cataract surgery. The aim of the study is to evaluate the lens implementation safety and efficacy after at least 24 months.
详细描述
This is a retro-prospective, post-marketing observational study of a CE-marked medical device. The efficacy and safety of the Asqelio monofocal intraocular lens (IOL) model QLIO130C from AST Products, Inc, Billerica, USA, will be studied in patients implanted according to standard clinical practice. Twelve-month follow-up data will be collected from the medical records of the patients included in the study, and after 24 months they will be scheduled for a review.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with ASQELIO monofocal model QLIO130C.
- •Subjects for whom postoperative emmetropia (±0.5 D spherical equivalent) was planned.
排除标准
- •Any pathology that reduces the potential Visual Acuity (VA) with its best correction beyond 0.30 logMAR.
- •Previous corneal surgery.
- •Rubella or surgery due to traumatic cataract.
- •Ocular trauma or refractive surgery.
- •Any other ocular or systemic condition that, in the opinion of the investigator, should exclude the subject from the study
结局指标
主要结局
Visual acuity
时间窗: At least 24 months after IOL implantation
Best corrected distance visual acuity in LogMAR units using the ETDRS chart
Incidence of Posterior capsular opacity
时间窗: 24 months after IOL implantation
Incidence of PCO
Intensity of Posterior capsular opacity
时间窗: 24 months after IOL implantation
Intensity of PCO determined using LOCSIII Classification
次要结局
- Intensity of Glistening(24 months after IOL implantation)
- Refraction(At least 24 months after IOL implantation)
- Incidence of Glistening(At least 24 months after IOL implantation)