Outcomes of a Trifocal IOL in Post-refractive Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To determine if preoperative IOL calculations or intraoperative aberrometry is more accurate when the two methods disagree in patients who have had previous refractive surgery undergo cataract surgery.
研究概览
简要总结
To compare the prediction error of ORA vs formula for post-LASIK cataract patients when PanOptix IOL was implanted. Using post-operative outcomes to determine if preoperative IOL calculations, including Barrett TK, Barrett Universal II, Hill RBF, ASCRS post-refractive calculator, or intraoperative aberrometry is more accurate when the two methods disagree in patients who have had previous refractive surgery undergo cataract surgery.
详细描述
The study will be non-interventional with data being collected prospectively and retrospectively between at least two surgical sites. All subjects will have previous LASIK and be at least 3 months post op PanOptix implantation. The study will enroll up to 200 patients and a statistical database will be created.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previous myopic refractive surgery
- •At least 3 months post op cataract surgery with a trifocal IOL
排除标准
- •Pre-existing or subsequent eye condition that interferes with accurate data collection (retinal detachment, etc.)
结局指标
主要结局
To determine if preoperative IOL calculations or intraoperative aberrometry is more accurate when the two methods disagree in patients who have had previous refractive surgery undergo cataract surgery.
时间窗: Pre-op to 9 month visit
1. Percentage of eyes within +/- .5D of target for each formula and ORA. 2. Overall % of eyes that have a disagreement between the two methods
次要结局
- Post-operative monocular visual acuity(3 to 9 month visit)
- Post-operative best corrected visual acuity(3 to 9 month visit)
- Post-operative visual acuity(3 to 9 month visit)
- Post-operative uncorrected visual acuity(3 to 9 month visit)
- Patient's quality of vision and reported side-effects(3 to 9 month visit)