NCT05735990已完成不适用
Retrospective Clinical Investigation of the Safety and Performance of 640PM Trifocal IOL Implantation in Patients With Cataract and/or Ametropia (Hyperopia, Myopia) and/or Presbyopia
Medicontur Medical Engineering Ltd1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022年10月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Corrected distance visual acuity (CDVA);
研究概览
简要总结
The clinical investigation objective is to evaluate safety and performance outcomes of trifocal IOL implantation to improve vision in patients with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia.
Retrospective data from preoperative status up to 12 month postoperative status will be collected from patients that were implanted with Medicontur's 640PM intraocular lens:
- Preoperative status: Preoperative Screening and Baseline
- Surgery: IOL implantation
- M1: 1 month +/- 2 weeks postoperative follow-up
- M3: 3 months +/- 1 month postoperative follow-up
- M12: 12 months +/- 3 months postoperative follow-up
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 males or females above 18 years of age;
- •Pseudophakic patients implanted with 640PM IOLs (Medicontur Medical Engineering Ltd. Inc., Zsámbék, Hungary);
- •Diagnosis of cataract and/or ametropia and/or presbyopia;
- •Subject who provided express consent authorizing the use of medical record data for biomedical research purposes. Patients who have participated in at least two follow up visits in the 12 months following IOL implantation
- •Patients for which the retrospective data for the primary endpoint is available and at least half of all the secondary endpoints measured in the time ranges specified in the protocol.
排除标准
- •Patients with any eye condition that could affect vision (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.);
- •regular anterior corneal astigmatism ≥ 1.20 D or irregular astigmatism ≥ 0.5 μm measured with Pentacam at 4 mm.
结局指标
主要结局
Corrected distance visual acuity (CDVA);
时间窗: 12 months after IOL implantation
次要结局
- VADC (monocular with best distance correction) under photopic conditions(3 months after IOL implantation)
- Visual Function by VF-14(12 months after IOL implantation;)
- Patient satisfaction self-reported by the participant(12 months after IOL implantation)
- Visual disturbances (photic phenomena, dysphotopsia) self-reported by the participant(12 months after IOL implantation)
- spectacle independence self-reported by the participant(12 months after IOL implantation)
- visual acuity at all intended distances (UDVA; CDVA, UIVA, DCIVA, UNVA, DCNVA)(1 and 12 months after IOL implantation;)
- Manifest spherical equivalent refraction (SEQ)(3 and 12 months after IOL implantation)
- CSDC (monocular with best distance correction): To evaluate CSDC under photopic conditions(3 months after IOL implantation;)
- CSDC (binocular without best distance correction) under photopic and mesopic conditions(12 months after IOL implantation;)
研究者
研究点 (1)
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