Multicentric Prospective Post-market Clinical Follow-Up (PMCF) Study to Investigate Clinical Outcomes, Rotational Stability and Patient Reported Outcomes After Implantation of a Monofocal Toric Intraocular Lens (IOL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 8
- 主要终点
- Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation
研究概览
简要总结
This is a multicentric, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC (study no. PHY2104)
详细描述
This is a multicentric, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC. The device under investigation is a hydrophobic acrylic monofocal toric intraocular lens (IOL) manufactured by the sponsor of this study. The refractive power of the lens has a spherical and a cylindrical component. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development and showing pre-existing corneal astigmatism.
If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be received an implantation with the monofocal parent lens PODEYE.
The study purpose is to determine safety, rotational stability, refractive and visual performance, contrast sensitivity, patient satisfaction and PCO rate after mono- or bilateral implantation of PODEYE TORIC intraocular lens.
In total approx. 30 patients will be recruited for this clinical study and undergo mono- or bilateral implantation of PODEYE TORIC intraocular lens. The maximum time between 1st and 2nd eye implantation is 30 days.
Subjects participating in the trial will attend a total of maximum 11 study visits over a period of 330-420 days (preoperative, operative, 1-2 days, 7-14 days, 30-60 days, 120-180 days, 330-420 days postoperative visits). 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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults ages 50 years or older on the day of screening who have clinically documented cataracts in both eyes;
- •Calculated IOL power (sphere and cylinder) is within the range of the investigational IOLs;
- •Regular corneal astigmatism (measured by a topographer);
- •Corneal astigmatism ≥0.75 D and ≤ 4.25 D (measured by an automatic keratometer) in one or both eyes;
- •Capability to understand and sign an IRB approved informed consent form and privacy authorization;
- •Clear intraocular media other than cataract;
- •Dilated pupil size large enough to visualize IOL axis markings postoperatively;
- •Best corrected visual acuity projected to be better than 0.2 logMAR after toric IOL implantation;
- •Willing and able to conform to the study requirements.
排除标准
- •Age of patient <50 years at the day of screening;
- •Regular corneal astigmatism <0.75 D or >4.25 D (measured by an automatic keratometer) in both eyes
- •Irregular astigmatism (measured by a topographer);
- •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;
- •History or presence of macular edema;
- •Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;
- •Clinically significant, uncontrolled glaucoma with expected negative impact on Contrast Sensitivity and/or visual acuity outcomes;
- •Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study;
- •Concurrent or previous (within 30 days) participation in another drug or device investigation;
- •Clinically significant dry eye as determined by the investigator's judgement;
- •Ocular surface disease (clinical symptoms or keratitis);
- •Patients showing contraindications as listed in the current Instructions for use (IFU);
- •Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgment (reason to be documented on eCRF).
- •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
Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation
时间窗: 6 months postoperative
The primary performance endpoint is to show statistically non-inferior rotational stability outcomes on PODEYE TORIC lens compared to CER data obtained for a multifocal toric IOL (POD FT) by the same manufacturer sharing the same haptic design but based on a hydrophilic lens material. The null hypothesis is that the absolute mean IOL rotation measured on PODEYE TORIC is not larger than the absolute mean IOL rotation reported in the current CER on POD FT lens. The alternative hypothesis is that the absolute mean IOL rotation measured on PODEYE TORIC is larger than the outcomes reported in the current CER on POD FT lens. The measure is taken at 6 months postoperative visit compared to the measurement performed within 10 minutes after surgery.
次要结局
- Change in cylindrical Power of the Eye(Pre-Op, 1 month postoperative, 6 months postoperative, 12 months postoperative)
- Best Corrected Distance Visual Acuity compared to historical Data(Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative)