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2024年4月10日
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.

注册库
clinicaltrials.gov
开始日期
2024年4月10日
结束日期
2025年6月30日
最后更新
19天前
研究类型
Observational
性别
All

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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