Prospective Post-Market Clinical Follow-Up (PMCF) Study to Investigate the Clinical Outcomes of a Premium Monofocal Intraocular Lens (IOL) in Comparison to an EDOF Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 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
Single center, prospective, randomised, controlled, double-blind post-market clinical follow-up (PMCF) study to compare the clinical outcomes of a premium monofocal intraocular lens (PhysIOL ISOPURE 1.2.3.) with clinical data obtained in a control group implanted with an EDOF IOL (Alcon Acrysof IQ Vivity).
详细描述
This is a single center, prospective, randomised, controlled, double-blind post-market clinical follow-up (PMCF) study whereby patients undergoing routine cataract surgery will have bilateral implantation of premium monofocal intraocular lenses (PhysIOL ISOPURE 1.2.3.) or EDOF lenses (Alcon Acrysof IQ Vivity). The patients will be randomized in a 1:1 ratio to receive the study or control lenses. Both IOLs, investigational device and control device, are CE approved and commercially available in the countries this clinical investigation 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 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. The control lens (Alcon Acrysof IQ Vivity) is a non-diffractive Extended Vision Posterior Chamber IOL.
The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.
Subjects participating in the trial will attend a total of 6 study visits (1 preoperative, 1 operative and 4 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically.
Primary and secondary endpoint data will be collected at the 120-180 days follow up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double-blind masking; Patient will not be informed which IOL model was implanted until end of the study. Outcomes assessors will not be informed which IOL model was implanted until end of the study.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cataractous eyes with no comorbidity;
- •Calculated IOL power is within the range of the study IOLs;
- •Male or female adults ages 50 years or older on the day of screening who have cataract(s) in one or both eyes;
- •Regular total corneal astigmatism ≤1.0 D (measured by topography method)
- •Clear intraocular media other than cataract;
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
- •Expected postoperative Best Corrected Distance Visual Acuity (CDVA) ≤ 0.2 logMAR;
- •Signed informed consent.
排除标准
- •Age of patient < 50 years;
- •Regular total corneal astigmatism >1.0 dioptres (measured by topography method)
- •Irregular astigmatism;
- •Difficulty for cooperation (distance from their home, general health conditions);
- •Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders);
- •Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema or macula pucker;
- •Previous intraocular or corneal surgery or intravitreal injection;
- •Traumatic cataract;
- •History or presence of macular edema;
- •Glaucoma with visual field defects;
- •Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
- •Amblyopia with monocular preoperative CDVA of >0.1 logMAR;
- •Cornea guttata;
- •Keratoconus;
- •Chronic uveitis;
- •Expected complicated surgery;
- •Significant dry eye;
- •Contra-indications as listed in the current Instructions for use (IFU);
- •Contra-indication or unwillingness to perform immediate sequential bilateral cataract surgery;
- •Concurrent or previous (within 60 days) participation in another drug or device investigation.
- •In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued when certain conditions are present at the time of surgery, including:
- •zonular instability or defect;
- •capsular fibrosis or other opacity; and
- •inability to fixate IOL in desired position. In such cases, the subject shall be followed until the condition has stabilized.
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: 6 months (120-180 days) postoperative
Non inferiority of ISOPURE 1.2.3. outcomes compared to the Acrysof IQ Vivity outcomes in terms of monocular Best Corrected Distance Visual Acuity (CDVA) by means of statistical significance. A significance level of 0.05 or lower (p \< 0.05) 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
- Safety (Rates of Adverse Events)(1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative)