Clinical Investigation of the Monofocal Toric IOL POD T 49P in Cataractous Eyes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Uncorrected visual acuity at Visit 4
研究概览
简要总结
This is a Multi-center, single-arm and non-masked study whereby patients undergoing routine cataract surgery be implanted with a hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC (model POD T 49P).
详细描述
This is a Multi-center, single-arm and non-masked study whereby patients undergoing routine cataract surgery will be implanted with a 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 (BVI Medical). 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.
In total approx. 28 patients, 56 eyes will be recruited for this clinical study and undergo implantation of PODEYE TORIC intraocular lens.
Subjects participating in the trial will attend a total of maximum 6 study visits over a period of 120-180 days (preoperative, operative, 1-2 days, 7-14 days, 30-60 days, 120-180 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Uncorrected visual acuity at Visit 4
时间窗: Postoperative Day 120-180
Uncorrected visual acuity at 5 m will be measured. Convert decimal visual acuity to logMAR value using the following formula. logMAR value = log10 (1/decimal visual acuity)
Amount of astigmatism at Visit 4
时间窗: Postoperative Day 120-180
Manifest cylindrical refraction for Best Collected Distance Visual Acuity will be measured at Visit 4.
次要结局
- IOL rotation(Pre-Op, 1 month postoperative, 6 months postoperative)
- Manifest cylindrical refraction(Pre-Op, 1 month postoperative, 6 months postoperative)
- Best Corrected Distance Visual Acuity(Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative.)