An Observational, Prospective, Post-Marketing Clinical Study of the ACRYSOF® IQ PanOptix Multifocal IOL in an Indian Population
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Best corrected binocular visual acuity at distance (4 m) post bilateral implantation
研究概览
简要总结
Brief Summary : The purpose of this Post Marketing Study is to study the safety and effectiveness of the ACRYSOF IQ PanOptix intraocular lens (IOL) in an Indian population.
Detailed Description: The study population will consist of adult Indian males and females, at least 18 years of age or older at the time of screening, with no ocular pathology that could confound study outcomes, who are advised bilateral cataract extraction
and who desire an IOL that provides the potential for correction of near, intermediate, and distance vision. Both eyes will be implanted. The second eye surgery will take place 15-30 days after the first eye surgery. Subjects will be followed for approximately 3 months after the second eye surgery. Total individual subject participation will be approximately 4 months. This study will be conducted in India.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
- •Advised cataract extraction in both eyes and agreed for bilateral implantation of ACRYSOF IQ PanOptix lens;
- •Preoperative regular keratometric astigmatism of ≤1.0 D in both eyes.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Pregnant or lactating, current or planned, during the course of the study;
- •Retinal abnormalities (Macular Degeneration, dystrophy, edema , traction or other pathologies affecting vision);
- •Clinically significant corneal abnormalities; 4.History of retinal conditions; 5.Previous refractive surgery, including LASIK; 6.Glaucoma; 7.Any condition that may not be appropriate to this study, as per the Investigator’s expert medical opinion.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Best corrected binocular visual acuity at distance (4 m) post bilateral implantation
时间窗: At 3 months
次要结局
- 1. Subjects will be assessed for monocular visual acuity at 1 month after each(implantation and monocular as well as binocular visual acuity 3 months post bilateral (second eye) implantation via various assessments)