Comparison of Outcomes With Multifocal Intraocular Lenses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Best distance corrected Visual Acuity at Distance, Near
研究概览
简要总结
The purpose of this study is to compare and evaluate the clinical outcomes of 6 kinds of Multifocal Intraocular Lenses: SN6AD1, SBL-3, LS-313 MF30, AT LISA tri 839 MP, ART, LS-313 MF30T.
详细描述
This study is a prospective randomized controlled trial to compare and evaluate the clinical outcomes of 6 kinds of Multifocal Intraocular Lenses, the outcome measurements include postoperative visual acuity, visual quality and complications. Patients enrolled in the study will be randomized to receive one of the Multifocal Intraocular Lenses mentioned above, and the clinical outcomes of each Multifocal Intraocular Lens will be assessed at several visits: 1 day, 1 week, 1 month, 3 months and months post-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 40 to 80 years old, either gender;
- •Patients with bilateral age related cataracts, require bilateral cataract phacoemulsification combined Intraocular Lens implantation;
- •Willing to undergo second eye surgery within 7 days after first eye surgery;
- •The potential postoperative visual acuity of 20/40 or better in both eyes;
- •Preoperative measurement of corneal astigmatism indicate the subjects are suitable for multifocal intraocular lenses implantation;
- •Capability to understand the informed consent and willing and able to attend study
排除标准
- •Preexisting ocular diseases or conditions other than age related cataracts, have contraindications for cataract surgery;
- •Preexisting systemic diseases or conditions that may confound the results of the study;
- •Previous ocular surgery history or ocular trauma that may confound the results of the study;
- •Require combined surgery that may confound the results of the study;
- •Previous participation in other clinical trial within 30 days of this study start;
- •Systemic or ocular medications that may confound the outcome of the intervention
- •Pregnant, lactating, or planning to become pregnant during the course of the trial;
结局指标
主要结局
Best distance corrected Visual Acuity at Distance, Near
时间窗: 3 months after surgery
Defocus curve
时间窗: 3 months after surgery
measured with distance correction for unilateral and bilateral
Contrast sensitivity
时间窗: 3 months after surgery
measured with CSV-1000HGT(VECTOR VISION, Greenville, OH)
Modulation Transfer Function (MTF) cut-off measured by OQAS II
时间窗: 3 months after surgery
Uncorrected Visual Acuity (UCVA) at Distance, Near
时间窗: 3 months after surgery
Ocular aberration
时间窗: 3 months after surgery
measured with a custom-built aberrometer
Ocular Scatter Index measured by Optical Quality Analysis System(OQAS) II
时间窗: 3 months after surgery
Strehl Ratio measured by OQAS II
时间窗: 3 months after surgery
Quality of Vision (QoV) Questionnaire score
时间窗: 3 months after surgery
Catquest- 9SF Questionnaire score
时间窗: 3 months after surgery
次要结局
- Rate of Spectacle Independence(6 months after surgery)
- Rate of Posterior Capsule Opacification(6 months after surgery)
- Refractive error after surgery(3 months after surgery)
- Rate of Nd:YAG Laser Posterior Capsulotomy(6 months after surgery)
研究者
A-Yong Yu
Clinical Professor
Wenzhou Medical University