Pilot Study With a Diffractive Trifocal IOL (POD AY 26P FineVision)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
The principal objective of the study is to determine the visual acuity at far, intermediate and near distances tested with optotypes at different distances from the eyes and tested with defocus addition lenses of patients implanted bilaterally with the POD 26P AY FineVision.
Secondary objective will be to test the glare and contrast sensitivity.
详细描述
This study is a pilot study. As such it will recruit a limited number of patients : 20. Patients recruited will suffer from cataract, have no comorbidity, expressed the desire for spectacle independence and have realistic expectations.
Descriptive statistics will be used to determine the visual acuities at any distance. The occurence of glare and the determination of the contrast sensitivity will also be determined.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Age-related cataract
- •Preoperative Corneal astigmatism < 0.75 D
- •Age 21 and older
- •Visual Acuity > 0.05
- •Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
- •Patient willing multifocal implantation and with realistic expectations.
排除标准
- •Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies, retinal pathology (diabetic maculopathy, myopic maculopathy, age related macular degeneration...)
- •Previous ocular surgery or trauma.
结局指标
主要结局
Visual acuity
时间窗: 3 months
At far, near and intermediate distance.
次要结局
- Contrast sensitivity(3 months)