NCT06250322
已完成
不适用
A Multicenter, Observational, Single Arm Study of the TECNIS Presbyopia-correcting Intraocular Lens
适应症Cataracts
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Cataracts
- 发起方
- Johnson & Johnson Surgical Vision, Inc.
- 入组人数
- 307
- 试验地点
- 37
- 主要终点
- Visual Symptoms
- 状态
- 已完成
- 最后更新
- 19天前
概览
简要总结
Ambispective post-market data collection on visual symptoms, patient satisfaction and surgeon experience with the TECNIS PC IOL.
研究者
入排标准
入选标准
- •Patients who are bilaterally implanted with TECNIS PC IOL and are at least 45 days postoperative from their second eye surgery
- •Clear intraocular media
- •Signed informed consent and data protection documentation
- •Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures
- •Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided
排除标准
- •Subjects with ongoing adverse events that might impact outcomes during the study
- •Use of systemic or ocular medication that may affect vision
- •Acute or chronic disease or condition, ocular trauma or surgery that may confound results
- •Patients with amblyopia, strabismus, nystagmus
- •Concurrent participation in another clinical trial
结局指标
主要结局
Visual Symptoms
时间窗: 3month postoperative
Patient questionnaires
Surgeon Experience
时间窗: 3month postoperative
Questionnaire
Visual Acuity
时间窗: 3month postoperative
Visual Acuity will be collected with standard clinical charts.
研究点 (37)
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