Evaluation of Quality of Vision and Spectacle Independence With Bilateral Implantation of the AcrySof® Panoptix® Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Emmetropic Subjects Who Are Spectacle Independent
研究概览
简要总结
This is a study to assess the spectacle independence and quality of vision of patients receiving the AcrySof® Panoptix® 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 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
Number of Emmetropic Subjects Who Are Spectacle Independent
时间窗: 3 months
Number of patients who have a 3-month postoperative manifest spherical equivalent refraction within 0.5 diopters (D) of plano, and ≤ 0.5 D of refractive cylinder (emmetropic subgroup) who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) - "a little of the time" or "none of the time").
次要结局
- Binocular Uncorrected Distance Visual Acuity(3 months)
- Binocular Uncorrected Intermediate Visual Acuity(3 months)
- Binocular Uncorrected Near Visual Acuity(3 months)
- Residual Refractive Cylinder(3 months)
- Binocular Corrected Distance Visual Acuity(3 months)
- Binocular Distance-corrected Near Visual Acuity(3 months)
- Spherical Equivalent Refraction(3 months)
- Quality of Vision Questionnaire(3 months)
- Overall Spectacle Independence(3 months)
- Binocular Distance-corrected Intermediate Visual Acuity(3 months)