Post-Approval Study of the TECNIS SYMFONY® Toric Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 475
- 试验地点
- 23
- 主要终点
- Rate of Bothersome Visual Symptoms
研究概览
简要总结
This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative, 6-month clinical study conducted at up to 50 sites in the USA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be at least 22 years old
- •have cataracts in both eyes
- •have a certain degree of astigmatism in at least one eye
- •sign the written informed consent
- •be willing and able to comply with examination procedures
- •understand, read and write English to complete informed consent and questionnaires
- •be available for study follow-up visits
- •Both eyes must qualify to be eligible to participate in the study
排除标准
- •Currently participating in any other clinical study or have participated in a clinical study during the last 30 days
- •Have a certain disease/illness such as poorly-controlled diabetes
- •Have certain ocular conditions such as uncontrolled glaucoma
- •Taking medication that may affect subject vision
- •Have irregular corneal astigmatism
- •Pregnant, plan to become pregnant during the study, or is breastfeeding
研究组 & 干预措施
Higher Cylinder Toric IOL
Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group.
干预措施: Higher Cylinder Toric IOL (Device)
Lower Cylinder Toric IOL
Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group.
干预措施: Lower Cylinder Toric IOL (Device)
结局指标
主要结局
Rate of Bothersome Visual Symptoms
时间窗: 6-month
The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.
Rate of Difficulty With an Activity Due to the Visual Symptoms
时间窗: 6-month
The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.
次要结局
未报告次要终点