NCT06005675已完成不适用
User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With 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
- 44
- 试验地点
- 4
- 主要终点
- Visual Acuities
研究概览
简要总结
Prospective 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
- Prospective
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 informed consent and data protection documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries;
- •Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures;
- •Ability to understand, read, and write in English
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 until after completion of the study visits;
- •Ongoing adverse events that might impact study measurements, as determined by the investigator;
- •Acute or chronic disease or condition, ocular trauma, or surgery that may confound study measurements (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
Visual Acuities
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 (4)
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