Safety,efficacy and rotational stability of different Multifocal Toric IOLs -One Year Prospective controlled clinical study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Visual acuity (UCDVA & BCDVA).Visual acuity (Near & Intermediate).Toric Marks Measurement (Rotational Stability) using Itrace.Refractive astigmatism.Spherical Equivalent
研究概览
简要总结
This is a Prospective, comparative clinical study of 2 different Multifocal Toric IOLs i.e, Eyecryl ACTV Diffractive Multifocal IOL and TECNIS Multifocal Toric with 3.25 near addition
It is a single centre study for 1 year duration. 64 Subjects(128 eyes)-32 subject(64 eyes) in each arm will be taken.
The primary objective of this clinical study is to characterize and compare the safety and effectiveness of these 2 Multifocal Toric IOLs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •Patients who has been implanted bilaterally with the Multifocal Toric IOL will be included in the Study.
- •Age 18 and older
- •Regular corneal topography and corneal astigmatism more than 0.75 D.
- •Best Corrected Visual Acuity to be 0.2 LogMAR or Lower
- •Clear intraocular media
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- •Patients who has given informed written consent.
排除标准
- •Any active ocular disease (Diabetic retinopathy, macular degeneration, glaucoma with field defects and irregular corneal astigmatism)
- •Previous intraocular and corneal surgery
- •Pregnancy & Lactation
- •Traumatic Cataract
- •Subject who are expected to required retinal laser treatment Concurrent participation in another drug or device Study.
结局指标
主要结局
Visual acuity (UCDVA & BCDVA).Visual acuity (Near & Intermediate).Toric Marks Measurement (Rotational Stability) using Itrace.Refractive astigmatism.Spherical Equivalent
时间窗: Preoperative Visit.Intraoperative Visit.Postoperative 1 Day.Postoperative 7 Days.Postoperative 30 Days.Postoperative 90 Days.Postoperative 180 Days.Postoperative 365 Days
次要结局
- Intraocular Pressure (IOP).Endothelial Cell Count.Pupil Size.Defocus CurveCorrected up to ± 4 D.(Preoperative Visit.Intraoperative Visit.Postoperative 1 Day.Postoperative 7 Days.Postoperative 30 Days.Postoperative 90 Days.Postoperative 180 Days.Postoperative 365 Days)