Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Binocular photopic uncorrected distance VA (at 3 months)
研究概览
简要总结
Millions of people have undergone laser vision correction surgery and are motivated to continue with spectacle independence as they develop presbyopia (gradual loss of your eyes' ability to focus on nearby objects)and cataract. However, having a history of refractive surgery, poses challenges in the selection of the IOLs and can lead to visual outcomes that are unpredictable. Data from an international registry and single prospective study show that Vivity IOL provided effective distance, intermediate and near vision in eyes with previous LASIK with minimal effects on day vision associated with the surgery. The purpose of this study is to evaluate the clinical outcomes of post-myopic refractive surgery patients implanted with the Clareon Vivity/Vivity Toric lenses
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •o Bilateral age-related visually significant cataracts in otherwise healthy eyes, undergoing uncomplicated bilateral sequential Clareon Vivity IOLs
- •Prior history of uncomplicated post-refractive myopic surgery (LASIK/PRK) with up to 1 enhancement treatment
- •Potential acuity measured post-operatively 20/25 or better in both eyes
- •Patients with regular astigmatism that can be managed with T3 toric lens or arcuate incision
排除标准
- •o Ocular or systemic comorbidities that may alter or reduce visual acuity and contrast sensitivity such as severe dry eye/ocular surface disease, glaucoma, macular degeneration, retinopathy, neuro-ophthalmic diseases, etc.
- •Prior ocular surgeries other than uncomplicated corneal refractive surgery and excluding RK
- •Patients with irregular astigmatism/topography (to rule out signs of potential ectasia), corneal dystrophies, and pupil abnormalities
- •Total HOA cutoff of ≤0.5, coma ≤0.3
- •RLE patients
结局指标
主要结局
Binocular photopic uncorrected distance VA (at 3 months)
时间窗: at 3 months
次要结局
- • Binocular photopic uncorrected VA at intermediate (66cm) and near (40cm)(at 3 months)