Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL Model TFNT00
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 主要终点
- Mean Binocular Defocus Visual Acuity (VA)
研究概览
简要总结
The purpose of this study is to investigate visual outcomes and assess safety at 12 months (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL.
详细描述
This study will be conducted in regions where the test article is approved at the time of study start.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision;
- •Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
- •Clear intraocular media other than cataract in both eyes;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
- •Ocular trauma, corneal transplant, retinal conditions, degenerative eye disorders, or color vision deficiencies;
- •Glaucoma (uncontrolled or controlled with medication) or ocular hypertension;
- •Pregnant or lactating;
- •Expected to require ocular surgical or retinal laser treatment;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
TFNT00
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
干预措施: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL (Device)
结局指标
主要结局
Mean Binocular Defocus Visual Acuity (VA)
时间窗: Day 20-40 and Day 120-180 from second eye implantation
Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best spectacle correction at a distance of 4 meters. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. The defocus VA summaries are based on the number of subjects evaluable for Best-Case Analysis Set and have data available at the corresponding visit. No formal statistical hypothesis testing was planned.
次要结局
未报告次要终点