At Least One-year Long-term Clinical Outcomes Following Monofocal Toric Intraocular Lens Implantation: Observational Prospective Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- SIFI SpA
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Evaluation of the Visual Performance
研究概览
简要总结
Evaluation, at least one-year long-term, of the clinical performance and safety of Mini Toric Ready Intraocular Lens (IOL), a monofocal toric intraocular lens.
详细描述
Observational prospective clinical investigation based on the medical records of patients who undergone uncomplicated cataract surgery with implantation of Mini Toric Ready IOL and on a clinical visit after at least one year from the surgery. Eyes with corneal astigmatism ≥0.75 diopters were included. Postoperative evaluations included monocular or binocular uncorrected and corrected distance visual acuity; contrast sensitivity measured after at least one-year postoperatively.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eighteen years of age or older at the time of surgery and diagnosed with unilateral or bilateral cataracts;
- •Preoperative total corneal astigmatism ≥0.75D;
- •Unilateral or bilateral cataract removal by phacoemulsification;
- •Clear intraocular media other than cataract;
- •Willing and able to complete all required postoperative visits;
- •Able to comprehend and sign a statement of informed consent consistent with local regulation for research in human subjects.
排除标准
- •Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days before the surgery.
结局指标
主要结局
Evaluation of the Visual Performance
时间窗: From 12 to 24 months post-surgery
Evaluate Mini Toric Ready Intraocular Lens (IOL) performance in terms of correction of spherical and cylindrical visual defects, corrected and uncorrected monocular and/or binocular distance visual acuity at least 12 months post implant.
次要结局
- Evaluation of the Stability(From 12 to 24 months post-surgery)