NCT06658119招募中不适用
Clinical Evaluation of Extended Depth-of-focus Intraocular Lens in Refractive Cataract Surgery
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年12月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
The goal of this clinical trial is to compare the clinical outcomes of two extended depth-of-focus intraocular lens after cataract surgery. The randomized controlled trail will enroll 90 participants. The participants will be randomly assigned to implant Tecnis Synergy ZFR00 or Tecnis Symfony ZXR00 intraocular lens. Follow-up visit will be performed till 3 months postoperatively to compare the visual acuity, subjective manifest refraction, and visual quality between groups.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age-related cataract patients aged between 40 to 80
- •patients with preoperative astigmatism less than 0.75 D, and kappa value less than 0.7 mm
- •patients who plan to receive femtosecond laser-assisted cataract surgery
排除标准
- •patients with ocular surface abnormalities such as irregular corneal astigmatism, corneal scarring, keratoconus, and pterygium)
- •patients with history of ocular trauma or surgery
- •patients with coexisting ocular disorders such as glaucoma, retinal vascular occlusive disease, retinal detachment, diabetic retinopathy, and any optic nerve-related pathologies
- •patients with concurrent severe systemic diseases
- •patients who lack of cooperation
结局指标
主要结局
Visual acuity
时间窗: 1 day, 1 week, 1 month, 3 months postoperatively
Visual acuity will be assessed using the Standard Logarithmic Visual Acuity Chart. The results will be recorded in decimal and converted to logMAR and Snellen equivalent.
次要结局
- contrast sensitivity(3 months postoperatively)
- Visual quality(3 months postoperatively)
- defocus curve(3 months postoperatively)
研究者
研究点 (1)
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