跳至主要内容
临床试验/NCT05821101
NCT05821101进行中(未招募)不适用

Clinical Outcomes of Clareon Vivity Intraocular Lens With Mini-Monovision Approach

Debbie S. Kuo, MD2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
2
主要终点
Binocular distance is target-corrected visual acuity (VA) at near 40cm.

研究概览

简要总结

Purpose is to study the clinical outcomes of Clareon Vivity and Clareon Vivity Toric intraocular lens (IOL) implants in patients who are planning to have cataract surgery in both eyes with a mini-monovision approach.

详细描述

A "mini-monovision" approach is one in which the dominant eye is corrected for distance vision while the non-dominant eye is corrected with a small amount of nearsightedness (-0.5 diopters). This approach can have the benefit of increasing ability to see over a broad range of vision without glasses. The Clareon Vivity and Vivity Toric lenses have been approved by the U.S. Food and Drug Administration (FDA) for visual correction of aphakia in adult patients following cataract surgery. It has lens technology that provides an extended depth of focus (more range of clear vision for distance, intermediate and near vision) compared to a standard monofocal (single focus) lens. None of the procedures in this study are experimental. However, the study is seeking additional information on clinical outcomes of the mini-monovision approach specifically using the Clareon Vivity and Vivity Toric lenses.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Adult patients with bilateral age-related visually significant cataracts in otherwise healthy eyes, undergoing bilateral sequential implantation within 21 days using Clareon Vivity and Clareon Vivity Torics
  • IOL powers between +10D to +30.0D, T3-T6
  • Potential acuity measured post-operatively 20/25 or better in both eyes

排除标准

  • History of ocular or refractive surgery
  • Ocular or systemic comorbidities that may alter or reduce visual acuity, contrast sensitivity, binocularity, or impair reading performance such as severe dry eye/ocular surface disease, glaucoma, macular degeneration, retinopathy, neuro-ophthalmic diseases, strabismus/amblyopia etc.
  • Patients with irregular astigmatism, corneal dystrophies, pupil abnormalities, zonular laxity
  • Intraoperative or postoperative complications

结局指标

主要结局

Binocular distance is target-corrected visual acuity (VA) at near 40cm.

时间窗: 3 month post-surgery

Increase in ability to see over a broad range of vision without glasses

次要结局

未报告次要终点

研究者

发起方
Debbie S. Kuo, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Debbie S. Kuo, MD

Ophthalmologist

Palo Alto Medical Foundation

研究点 (2)

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