Spectacle Independence and Overall Satisfaction With Bilateral Implantation of the AcrySof® Panoptix® Toric Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Spectacle independence - emmetropia
研究概览
简要总结
The study was designed to assess the spectacle independence and satisfaction of patients receiving the AcrySof® Panoptix® Toric intraocular lens (IOL) after uneventful cataract surgery.
详细描述
This study is a single-arm unmasked clinical evaluation study of spectacle independence after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a spectacle independence and a quality of life questionnaire, as well as measurement of bilateral visual acuity 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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Spectacle independence - emmetropia
时间窗: 3 months
Percent of patients with ≤ 0.5D of refractive cylinder and ≤ 0.50D of absolute residual spherical equivalent refraction postoperatively who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire, or PRSIQ1 - "a little of the time" or "none of the time")
次要结局
- Binocular uncorrected intermediate visual acuity(3 months)
- Binocular uncorrected distance visual acuity(3 months)
- BInocular uncorrected near visual acuity(3 months)
- Monocular corrected distance visual acuity(3 months)
- VFQ-14(3 months)
- Binocular best-corrected distance visual acuity(3 months)
- Uncorrected preferred reading distance(3 months)
- Binocular distance-corrected intermediate visual acuity(3 months)
- Binocular distance-corrected near visual acuity(3 months)
- Spherical equivalent refraction(3 months)
- Spectacle independence - overall(3 months)
- Residual astigmatism(3 months)
- Choose lens again(3 months)
- Binocular uncorrected visual acuity at preferred reading distance(3 months)