Evaluation of Efficacy and Long-term Safety for Lucidis Instant Focus© - PMCF Study Protocol
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Visual acuity measure BCVA photopic
研究概览
简要总结
The objectives of the study is to evaluate efficacy and long-term safety of the Lucidis lens. Through this study, the objective is to obtain an up-to-date clinical evaluation of the medical device thus supplementing data from experimental trials. Clinical and functional changes in the implanted eyes among a patient population in which the opaque crystalline lens resulting from cataract was removed and replaced by a Lucidis IOL will be described.
详细描述
Refractory function in patients with a cataract is mainly restored by implanting intra-ocular lenses (IOL) destined to replace the crystalline lens. While new surgical techniques for removing the crystalline lens have been developed, these lenses have been considerably perfected to resemble the natural crystalline lens as closely as possible.
The objectives of the study is to evaluate efficacy and long-term safety of the Lucidis lens. Through this study, the objective is to obtain an up-to-date clinical evaluation of the medical device thus supplementing data from experimental trials. Clinical and functional changes in the implanted eyes among a patient population in which the opaque crystalline lens resulting from cataract was removed and replaced by a Lucidis IOL will be described.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients (≥18 years)
- •having agreed to take part in the study and complete post-operative follow-up requirements (by having signed the information leaflet-informed consent form);
- •for whom the physician made the decision to implant a Lucidis
排除标准
- •patient included in an interventional therapeutic trial at the time of inclusion;
- •patient presenting contraindications for the implantation of an intraocular lens;
- •patient presenting an ophthalmic disorder liable to interfere with the study endpoints;
- •patient presenting with an astigmatism ≥1.0 D;
- •patient refusing or unable to comply with the follow-up procedures in the study (patient unable to be reached by telephone, liable to be lost to follow-up, etc.);
- •History of previous intraocular surgery in the study eye in the previous 6 months;
- •patient is pregnant, breast-feeding or unable to make the decision to participate in a clinical investigation (e.g. mentally ill or handicapped person)
结局指标
主要结局
Visual acuity measure BCVA photopic
时间窗: 1 year
Far Best Corrected Visual Acuity in photopic conditions
Visual acuity measure UCVA mesopic
时间窗: 1 year
Near, intermediate and far Uncorrected visual acuity in mesopic conditions
Visual acuity measure BCVA mesopic
时间窗: 1 year
Far Best Corrected Visual Acuity in mesopic conditions
Visual acuity measure UCVA photopic
时间窗: 1 year
Near, intermediate and far Uncorrected visual acuity in photopic conditions
次要结局
- Safety assessment(1 year)
- Contrast sensitivity measure mesopic(1 year)
- Contrast sensitivity measure photopic(1 year)