Clinical Outcomes of Clareon Vivity Intraocular Lens With Mini-Monovision Approach
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
- 否
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
Debbie S. Kuo, MD
Ophthalmologist
Palo Alto Medical Foundation
