Clinical Investigation of AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of the TFNT20 low cylinder power intraocular lens when implanted in the eye to replace the natural lens following cataract removal.
详细描述
Subjects will attend a total of 5 to 9 visits, depending on whether one eye or both eyes are implanted. The second eye surgery, if applicable, will occur 1 to 30 days after the first eye surgery. Total individual duration of participation will be up to 4 months, including an up to 2-month preoperative period.
This study will be conducted in Japan.
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
- •Eligible to be implanted with AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20 in at least one eye.
- •Potential postoperative Best Corrected Distance Visual Acuity (BCDVA) of 0.5 decimal or better.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Irregular corneal astigmatism.
- •History of anterior segment, posterior segment, or optic nerve pathology.
- •History of previous intraocular or corneal (refractive or trauma related) surgery.
- •Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser assisted in situ keratomileusis (LASIK).
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
时间窗: Day 30-60 postoperative
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism.
次要结局
- Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60)(Day 30-60 postoperative)
- Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)(Day 30-60 postoperative)