NCT04210232已完成不适用
Post-market Evaluation of Surgeon Feedback on TECNIS® TORIC II Intraocular Lens (IOL)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 24
- 主要终点
- Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II
研究概览
简要总结
This is a multicenter, prospective, single-arm, open-label, clinical study of the commercially available TECNIS Toric II, Model ZCU IOL. The study will be conducted in up to 1100 subjects enrolled with 1,000 subjects needing unilateral or bilateral cataract surgery across up to 50 US study sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral or bilateral cataracts for which phacoemulsification extraction and posterior chamber IOL implantation have been planned;
- •Preoperative corneal astigmatism of one diopter or more in the operative eye;
- •Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/30 Snellen or better;
- •Clear intraocular media other than cataract in each eye;
- •Ability to understand, read and write English in order to consent to study participation;
- •Availability, willingness, sufficient cognitive awareness to comply with examination procedures;
- •Signed Informed Consent Document (ICD) and Health Insurance Portability and Accountability Act (HIPAA) authorization.
排除标准
- •Recurrent severe anterior or posterior segment inflammation or uveitis;
- •Compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible;
- •Circumstances that would result in damage to the endothelium during implantation;
- •Suspected ocular microbial infection;
- •Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects;
- •Known ocular disease or pathology that, in the opinion of the investigator, may affect visual acuity or require surgical intervention during the course of the study, [macular degeneration, cystoid macular edema, proliferative diabetic retinopathy (severe), uncontrolled glaucoma, irregular corneal astigmatism, choroidal hemorrhage, concomitant severe eye disease, extremely shallow anterior chamber, microphthalmos, non-age related cataract, severe corneal dystrophy, severe optic nerve atrophy, etc.];
- •Planned monovision correction;
- •Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study.
结局指标
主要结局
Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II
时间窗: 3 months postoperative
Percent of Eyes Rated Very Satisfied or Satisfied with Clinical Outcomes. This endpoint was assessed based on the question "Please rate your overall level of satisfaction with the clinical outcomes achieved in the implanted eye" in the Surgeon Satisfaction Questionnaire (SSQ).
次要结局
未报告次要终点
研究者
研究点 (24)
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