NCT05075746已完成不适用
Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 3
- 主要终点
- Mean Reduction in Cylindrical Power of the Eye
研究概览
简要总结
The primary objective of this study is to evaluate the performance of the enVista Toric 0.9D vs non-Toric IOL.
详细描述
The performance of the enVista Toric IOLs will be compared with that of enVista non-Toric (spherical) IOL. At least 384 eyes (n= 192 per lens type) from 3-4 Canadian centers will be investigated.
This is a retrospective chart review for preoperative and postoperative data conducted at least 4 weeks after IOL implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females subjects age 18 or older on the date of surgery
- •Implant of enVista Toric IOL and/or enVista non-Toric (spherical) IOL in at least one eye
- •Data available at least 4 weeks after IOL implantation
- •Eyes must qualify for the 0.9D toric lens based on the Barrett Toric Calculator (flipped axis must be less than 0.2D) (https://ascrs.org/tools/barrett-toric-calculator)
- •Study eyes were implanted with the 0.9D toric lens
- •Control eyes were not implanted with the 0.9D toric lens and implanted with a spherical (non-toric) equivalent instead
排除标准
- •History of uncontrolled or clinically significant ocular comorbidities for the treated eye(s) before the surgery (e.g., dry eyes, retinal pathology, etc.)
- •BCDVA of 20/25 or worse for the treated eye(s) after the surgery
- •Excessive IOL rotation > 10 degrees (Toric IOLs only) for the treated eye(s) after the surgery
结局指标
主要结局
Mean Reduction in Cylindrical Power of the Eye
时间窗: 4 weeks after IOL implantation
Reduction in the cylindrical power of the eye is defined as the difference between the magnitudes of the preoperative keratometric cylinder and the residual refractive cylinder (referenced to the corneal plane).
次要结局
未报告次要终点
研究者
研究点 (3)
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