NCT05961046终止不适用
Visual Performance of the Vivity IOL in Post-myopic LASIK and PRK Patients
Laser & Corneal Surgery Associates2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2023年8月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Binocular corrected distance visual acuity
研究概览
简要总结
The objective is to evaluate visual outcomes and patient satisfaction in patients with a history of myopic LASIK or PRK who will have completed cataract surgery with the Vivity IOL.
详细描述
This study Prospective, non-interventional, single-center, single-surgeon, single-arm observational study of visual outcomes and patient satisfaction in patients with a history of myopic LASIK or PRK who will have completed cataract surgery with the Vivity IOL. Subjects will be assessed at least 3 months postoperatively. Clinical evaluations will include administration of a satisfaction questionnaire (IOLSAT), as well as measurement of binocular and monocular visual acuities, defocus curve, and manifest refraction.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are eligible for the study if they meet the following criteria:
- •Note: Ocular criteria must be met in both eyes.
- •Adult (at least 40 years) patients with a history of successful myopic LASIK/PRK and underwent bilateral uncomplicated cataract surgery with non-toric Alcon Vivity IOL at least 3 months before enrollment.
- •Monocular BCDVA 20/25 or better.
- •Patients may be >2 weeks post-YAG capsulotomy for visually significant PCO.
- •Post-operative sphere ≤0.50D, astigmatism ≤0.50D, and MRSE < 0.75D.
排除标准
- •If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- •Patients with corneal refractive surgery complications, significant ocular pathology, including moderate and severe dry eye, retina, optic nerve (including glaucoma) and corneal pathologies (e.g. corneal dystrophy, edema, significant scarring), limiting or affecting visual potential, in the opinion of the surgeon.
- •Patients undergoing cataract removal with MIGS procedure.
- •Patients with h/o ocular surgery, other than corneal refractive surgery, that may limit or affect visual potential in the opinion of the surgeon.
- •The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- •Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
结局指标
主要结局
Binocular corrected distance visual acuity
时间窗: 3 months after surgery
次要结局
- Binocular uncorrected visual acuity(3 months after surgery)
- Satisfaction Questionnaire(3 months after surgery)
- Refractive Outcomes(3 months after surgery)
- Monocular corrected visual acuity(3 months after surgery)
- Visual Disturbance Questionnaire(3 months after surgery)
- Binocular Defocus curve(3 months after surgery)
- Monocular uncorrected visual acuity(3 months after surgery)
- Binocular corrected visual acuity(3 months after surgery)
研究者
研究点 (2)
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