Patient Satisfaction and Visual Outcomes After Bilateral Implantation of a Novel Non-Diffractive Extended Vision Toric Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Monocular best distance-corrected near visual acuity
研究概览
简要总结
The purpose of this study is to evaluate patient satisfaction after bilateral implantation of Vivity Toric Extended Vision Intraocular lens and visual outcomes.
详细描述
To evaluate and report outcomes including postoperative uncorrected visual acuity, postoperative best corrected visual acuity, postoperative refractive error, and IOL rotational stability after Vivity Toric Extended Vision intraocular lens (IOL) implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Calculated lens power within study IOL range of 15.0 diopters to 25.0 diopters and toric range of T3 to T6
- •Willing and able to comprehend informed consent form and to complete 1 day and 3-4 month postoperative visit
- •Potential postoperative best corrected distance visual acuity of 20/20 or better in each eye based on medical opinion of investigator
排除标准
- •Ocular pathology or comorbidity that could reduce potential postoperative best corrected distance visual acuity
- •Ocular trauma or zonular weakness/instability
- •Diagnosis of glaucoma or high-risk glaucoma suspect
- •Previous refractive surgery
- •Unreliable preoperative biometry measurements
- •Severe dry eye or ocular surface disease
结局指标
主要结局
Monocular best distance-corrected near visual acuity
时间窗: 4 months
Monocular best distance-corrected near visual acuity
Monocular best corrected distance visual acuity
时间窗: 4 months
Monocular best corrected distance visual acuity
Monocular visual acuity at distance
时间窗: 4 months
Monocular uncorrected distance visual acuity
Binocular visual acuity at distance
时间窗: 4 months
Binocular uncorrected distance visual acuity
Binocular best corrected distance visual acuity
时间窗: 4 months
Binocular best corrected distance visual acuity
Binocular best distance-corrected intermediate visual acuity
时间窗: 4 months
Binocular best distance-corrected intermediate visual acuity
Binocular best distance-corrected near visual acuity
时间窗: 4 months
Binocular best distance-corrected near visual acuity
Monocular best distance-corrected intermediate visual acuity
时间窗: 4 months
Monocular best distance-corrected intermediate visual acuity
次要结局
- Residual refractive cylinder(4 months)