跳至主要内容
临床试验/NCT06250322
NCT06250322已完成不适用

A Multicenter, Observational, Single Arm Study of the TECNIS Presbyopia-correcting Intraocular Lens

Johnson & Johnson Surgical Vision, Inc.37 个研究点 分布在 8 个国家目标入组 307 人开始时间: 2024年4月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
307
试验地点
37
主要终点
Visual Symptoms

研究概览

简要总结

Ambispective post-market data collection on visual symptoms, patient satisfaction and surgeon experience with the TECNIS PC IOL.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

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.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (37)

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