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临床试验/NCT04670575
NCT04670575已完成不适用

Vivity Outcomes in Patients With Early Stage Glaucoma

Vance Thompson Vision1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Uncorrected Distance Visual Acuity

研究概览

简要总结

The goal of the study is to determine the visual outcomes in patients with mild, pre-perimetric glaucoma who undergo cataract surgery with implantation of the Alcon Vivity Extended Range Intraocular Lens (IOL).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients at least age 45 years of age undergoing uncomplicated cataract surgery with optional concomitant minimally invasive glaucoma surgery (MIGS)
  • Subjects with documented diagnosis of pre-perimetric glaucoma
  • Calculated lens power within Vivity/Vivity toric range
  • Willing and able to comprehend informed consent and complete 4-6 month post-op visit
  • Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion

排除标准

  • Ocular comorbidity, other than pre-perimetric glaucoma, that could reduce the potential postoperative BCDVA
  • Previous ocular surgery including refractive surgery
  • Subjects who are pregnant or plan to become pregnant during the course of the study.

结局指标

主要结局

Uncorrected Distance Visual Acuity

时间窗: 4-6 months

Uncorrected Near Visual Acuity

时间窗: 4-6 months

Uncorrected Intermediate Visual Acuity

时间窗: 4-6 months

次要结局

  • Mean Refractive Spherical Equivalent(4-6 months)
  • Contrast Sensitivity(4-6 months)
  • Patient Satisfaction and Spectacle Independence Survey Results(4-6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Vivity Outcomes in Patients With Early Stage Glaucoma | 临床试验