Comparison of Visual Outcomes After Implantation of the POD 26P AY FT (PhysIOL) and the POD 26P AY F (PhysIOL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Determine the equivalence of the glare
研究概览
简要总结
There is no difference of the photic phenomena in the two groups.
The study will be a prospective non-randomised controlled study. The target is then to determine the equivalence in the glare. Assumption of Type I error is p=0.05 as level of significance and Type II error is alpha=0.8 as power.
详细描述
The study will be a prospective non-randomised controlled study. The target is then to determine the equivalence in the glare. Assumption of Type I error is p=0.05 as level of significance and Type II error is alpha=0.8 as power.
We used the 'TrialSize' package of the R software. Here are the parameters defined for the sample size calculation:
- Alpha: 0.05
- Power : 0.90
- Two sided test
- Equal group allocation
- Standard deviation for the two groups (POD 26P AY F et POD 26P AY FT) equal to 0.10
- Expected mean for the two groups (POD 26P AY F et POD 26P AY FT) equal to 0.89 (true difference between the means equal 0)
- An equivalence limit of 0.05, 0.10 and 0.15 Equivalence limit: 0.15 In order to show no difference between these two groups, 12 patients by groups are needed. With a drop-out of 15%, we obtain 30 patients (15 patients by group) to recruit in order to obtain 24 valuable patients.
Equivalence limit: 0.10 In order to show no difference between these two groups, 26 patients by groups are needed. With a drop-out of 15%, we obtain 62 patients (31 patients by group) to recruit in order to obtain 52 valuable patients.
This total number of subjects with such requirement is 26 patients in each group.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
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
Determine the equivalence of the glare
时间窗: 3 Months
The primary endpoint is to show statistically equivalent outcomes on glare at the 3 months follow up visit. A significance level of p = 0.05 will be considered statistically significant.
次要结局
- Centration(6 Months)
- Measurement of far, intermediate and near visual acuity(6 Months)
- Equivalence of the visual acuity and the contrast sensitivity(6 Months)
- Refraction(6 Months)
- Rotational stability(6 Months)