A prospective,randomized comparative clinical study to compare the safety and efficacy of different Hydrophobic Aspheric Monofocal Intraocular lenses
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- To compare the visual outcomes, contrast sensitivity and patient satisfaction after IOL implantation
研究概览
简要总结
This is a prospective, randomised, single centre, comparative clinical study to evaluate the safety and efficacy ( visual outcomes, contrast sensitivity and patient satisfaction) of different hydrophobic aspheric monofocal intraocular lenses on patients, 18 years and older, undergoing cataract surgery fulfilling the inclusion criteria and who are willing to participate in the clinical trial. Optiflex genesis, Eyecrylplus ASHFY600 and Tecnis 1 are the three investigational IOLs being used in the study. Sample size of 168 eyes (56 eyes in each arm) considering 20% drop out rate is required to prove the null hypothesis mean change in BCVA for all the three investigational products are same vs the alternative hypothesis of unequal mean change in BCVA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •age 18 and older Best corrected visual acuity to be 0.2 logmar or lower cataract calculated IOL power within range of investigational IOL subjects are willing and understand and sign informed consent subjects are willing and able to attend postoperative examinations as per schedule.
排除标准
- •previous intraocular and corneal surgery pregnancy and lactation traumatic cataract concurrent participation in another drug or device study chronic uveitis patients receiving chloroquine treatment corneal dystrophy or endothelial insufficiency microphthalmia active ocular diseases( active diabetic retinopathy, uncontrolled glaucoma).
结局指标
主要结局
To compare the visual outcomes, contrast sensitivity and patient satisfaction after IOL implantation
时间窗: Time-frame: pre-op, 1,7, 30,90,180 and 365 days follow up
Uncorrected visual acuity
时间窗: Time-frame: pre-op, 1,7, 30,90,180 and 365 days follow up
best corrected visual acuity
时间窗: Time-frame: pre-op, 1,7, 30,90,180 and 365 days follow up
contrast sensitivity
时间窗: Time-frame: pre-op, 1,7, 30,90,180 and 365 days follow up
次要结局
- high order aberrations(manifest refraction)