Multicentric Clinical Study to Determine Safety and Efficacy of a Hydrophobic Acrylic Trifocal Intraocular Lens (IOL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 14
- 主要终点
- Primary Safety Endpoint: Rates of Adverse Events
研究概览
简要总结
The study will be a multicentric, prospective open-label ethics committee approved clinical study to investigate safety, visual outcomes, contrast sensitivity and rotational stability after bilateral implantation of Isatis TF IOL following cataract surgery.
详细描述
This is a staged, multicentric, controlled, prospective, open-label clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of hydrophobic acrylic refractive trifocal intraocular lenses (Isatis TF) or the monofocal control device Isatis.
The investigational device, Control lens 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 is a hydrophobic acrylic trifocal intraocular lens (IOL) manufactured by the sponsor of this study. The trifocality of this investigational device is based on a purely refractive principle with the goal to provide additional near and intermediate visual acuity with low photic side effects. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development.
The control device (Isatis) is a hydrophobic acrylic monofocal intraocular lens to be implanted during cataract surgery. This control lens is CE approved and commercially available in Spain. Isatis monofocal lens is the parent lens of the device under investigation and both lenses share mechanical and material properties.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Clinically documented age-related cataract in both eyes with no comorbidity;
- •Calculated IOL power is within the range of the investigational IOLs;
- •Male or female adults ages 50 years or older on the day of screening who have cataracts in both eyes;
- •Regular corneal astigmatism (measured by topographer)
- •Astigmatism ≤1.0 D (measured by an automatic keratometer)
- •Clear intraocular media other than cataract;
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
- •Patient is willing to receive bilateral implantation of a trifocal IOL (this inclusion criteria applies only to the study group, not the control group);
- •Signed informed consent.
排除标准
- •Age of patient < 50 years;
- •Regular corneal astigmatism >1.0 dioptres (measured by an automatic keratometer)
- •Irregular astigmatism (measured by topographer);
- •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 with AMD suspicious eyes as determined by OCT examination;
- •Previous intraocular or corneal surgery;
- •Traumatic cataract;
- •Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;
- •Ocular hypertension, suspicious glaucoma or glaucoma;
- •Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
- •Expected complicated surgery;
- •Ocular surface disease (clinical symptoms or keratitis);
- •Pregnancy or lactation;
- •Second eye treatment will only be performed when Best Corrected Distance Visual Acuity (CDVA) of first eye is ≤ 0.2 logMAR (≥ 0.63 decimal);
- •Concurrent 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;
- •need for iris manipulation;
- •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
Primary Safety Endpoint: Rates of Adverse Events
时间窗: 120-180 days postoperative
The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to reference data stated in the according ISO standard for posterior intraocular lenses (EN ISO 11979-7:2018) based on minimum 100 subjects.
Primary Performance Endpoint: Best Corrected Distance Visual Acuity
时间窗: 120-180 days postoperative
The primary performance endpoint is to show non inferiority of Isatis TF compared to the monofocal comparator in terms of best corrected distance visual acuity (CDVA) by means of statistical significance.
次要结局
- Secondary Performance Endpoint: Distance Corrected Intermediate Visual Acuity (DCIVA)(120-180 days postoperative)
- Secondary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data(120-180 days postoperative)
- Secondary Performance Endpoint: Distance Corrected Near Visual Acuity (DCNVA)(120-180 days postoperative)