Posterior Capsule Opacification (PCO) Evaluation of the AcrySof SN60AT Lens vs. SN60WF Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Posterior Capsule Opacification (PCO)
研究概览
简要总结
To assess posterior capsule opacification (PCO) in patients implanted with either the AcrySof SN60AT lens or the AcrySof SN60WF lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with bilateral senile cataracts
- •Age > 50 years
- •Fit for hospital follow ups
- •Pupils dilating > 6mm preoperatively
- •Eyes expected to see 6/12 or better postoperatively
排除标准
- •On treatment for glaucoma
- •Other ocular pathology
- •Previous ocular surgery
研究组 & 干预措施
SN60AT
Implantation with the AcrySof Intraocular Lens Model SN60AT
干预措施: SN60AT (Device)
SN60WF
Implantation with the AcrySof Intraocular Lens Model SN60WF
干预措施: SN60WF (Device)
结局指标
主要结局
Posterior Capsule Opacification (PCO)
时间窗: 2 years after surgery
Thickening and opacification of the transparent membrane on which the intraocular lens is placed assessed by taking a digital retroillumination image of each eye with a dedicated retroillumination camera system. The photographs were analyzed with POCO software to measure the percentage area of PCO in the capsulorhexis area.
100% LogMAR Best Corrected Visual Acuity (BCVA)
时间窗: 24 months after surgery
Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under high contrast (100%), which means that there was maximum contrast between the letters on the chart and the background. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
9% LogMAR Best Corrected Visual Acuity (BCVA)
时间窗: 24 months after surgery
Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under low contrast (9%), which means that there was low contrast between the letters on the chart and the background. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
次要结局
未报告次要终点