Clinical Study to Investigate Visual Performance, Contrast Sensitivity and Patient Satisfaction After Implantation of a Premium Monofocal Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 6
- 主要终点
- monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.
研究概览
简要总结
Multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopure 1.2.3. intraocular lenses following cataract surgery.
The study treatment itself is not part of this observational clinical investigation. Only patients that already have been implanted with the device under investigation qualify for this retro- prospective observational clinical study.
详细描述
The study is a multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopure 1.2.3. intraocular lenses following cataract surgery.
The study treatment itself is not part of this observational clinical investigation. Only patients that already have been implanted with the device under investigation qualify for this retro- prospective observational clinical study.
Isopure 1.2.3. is CE approved and commercially available in the countries this clinical investgation is being carried out. The investigational device and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient.
The study will be carried out in up to five clinical centers in Spain. The device under investigation (Isopure 1.2.3.) is a hydrophobic, glistening-free, acrylic Premium Monofocal intraocular lens (IOL) manufactured by the sponsor of this study, PhysIOL sa/nv.
Subjects participating in the trial will attend a total of maximum 1 study visit (from 120 days post-operative). This study visit will be minimum 20 days after the surgery of the 2nd eye. Subjects would have the option for unscheduled visits if required medically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Male or female adults ages 45 years or older on the day of treatment that were mono- or bilaterally implanted with Isopure 1.2.
- •intraocular lens minimum 120 days before the study visit;
- •Maximum time between first and second eye treatment: 45 days (this accounts for bilateral implantations only);
- •Capability to understand and sign an IRB approved informed consent form and privacy authorization;
- •Clear intraocular media;
- •Minimum set of retrospective preoperative and intraoperative data available as outlined in the examination matrix;
- •Willing and able to conform to the study requirements.
排除标准
- •• Age of patient <45 years at the day of surgery;
- •Time between first and second eye treatment: >45 days (this accounts for bilateral implantations only);
- •Subjects who underwent previous intraocular or corneal surgery other than IOL implantation;
- •Subjects with diagnosed degenerative visual disorders (e.g. AMD or CME);
- •Subjects in whom in-the-bag implantation was not possible;
- •Subjects in whom surgical complications occurred (e.g. posterior rupture).
- •Subjects showing glaucoma;
结局指标
主要结局
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.
时间窗: From 120 days postoperative
No statistically significant difference between the monocular CDVA from 4 months follow up visit when compared to the parent IOL (Micropure 1.2.3). A significance level of 0.025 or lower (p \< 0.025) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018.
次要结局
未报告次要终点