NCT05991960已完成不适用
Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 12
- 主要终点
- Manifest Refraction
研究概览
简要总结
Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously bilaterally implanted with TECNIS Odyssey IOL, following cataract extraction;
- •Enrollment at least 21 days after second eye surgery;
- •Clear intraocular media in each eye.
- •Signed consent and data protection documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries.
排除标准
- •Concurrent participation in an interventional clinical trial during the time from which the data will be collected;
- •Use of systemic or ocular medication that may affect vision;
- •Prior corneal refractive surgery in each eye (i.e., LASIK, PRK, SMILE, RK, CK); NOTE: Limbal relaxing incisions (LRI) are permissible as planned at the time of surgery (intraoperatively) but not postoperatively within the retrospective analysis window;
- •Ongoing adverse events in each eye that might impact outcomes during the study visit as determined by the investigator;
- •Acute or chronic disease or condition, ocular trauma or surgery that may affect vision in each eye (e.g., clinically significant macular degeneration, glaucoma, cystoid macular edema, proliferative diabetic retinopathy, keratoconus etc.).
- •Amblyopia, strabismus, nystagmus in each eye.
结局指标
主要结局
Manifest Refraction
时间窗: 1-month postoperative
Manifest Refraction will be collected via observed case data in units of diopters.
Visual Symptoms/Complaints
时间窗: 1-month postoperative
Visual Symptoms/Complaints will be measured using a questionnaire on a 5-point scale.
Visual Acuity
时间窗: 1-month postoperative
Visual Acuity will be collected via observed case data in units of logMAR.
次要结局
未报告次要终点
研究者
研究点 (12)
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