Clinical Investigation of the AcrySof® IQ PanOptix™ IOL Model TFNT00
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 3
- 主要终点
- Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of the AcrySof® IQ PanOptix™ Intraocular Lens (IOL) Model TFNT00 when implanted to replace the natural lens following cataract removal.
详细描述
Eligible subjects will attend a total of 10 visits over a 7-month period. Subjects will complete a preoperative examination of both eyes (Visit 0), followed by implantation of the IOL at the operative visit for each eye (Visit 00/00A), and up to 7 postoperative visits (each eye examined at Day 1-2 (Visit 1/1A), Day 7-14 (Visit 2/2A), and Day 30-60 (Visit 3/3A), with a binocular visit at Day 120-180 (Visit 4A) after the second implantation. The second implantation will occur within 30 days of the first.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to comprehend and sign a statement of informed consent;
- •Willing and able to complete all required postoperative visits;
- •Cataracts in both eyes with planned cataract removal by phacoemulsification;
- •Calculated lens power within the available range;
- •Potential postoperative best corrected distance visual acuity (BCDVA) of 0.5 decimal or better in both eyes;
- •Able to undergo second eye surgery within 30 days of the first eye surgery.
排除标准
- •Significant irregular corneal aberration as demonstrated by corneal topography;
- •Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity;
- •Degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses;
- •Previous refractive surgery;
- •Diabetic retinopathy
- •Other eye conditions as specified in the protocol
- •Pregnant.
研究组 & 干预措施
PanOptix IOL
AcrySof® IQ PanOptix™ IOL, bilateral implantation
干预措施: AcrySof® IQ PanOptix™ IOL (Device)
结局指标
主要结局
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
时间窗: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation
VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
时间窗: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation
Visual acuity (VA) was tested monocularly (each eye separately) under well-lit conditions with the subject's best spectacle correction at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
时间窗: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation
VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 60 cm is the VA at 60 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.
次要结局
未报告次要终点