NCT06767319已完成不适用
Comparison of Depth of Focus Testing Methods
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 4
- 主要终点
- The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group.
研究概览
简要总结
The purpose of this clinical study is to evaluate the difference in depth of focus measured with two methods in patients implanted with either TECNIS 1-piece Monofocal IOL or TECNIS Eyhance IOL:
- Trial lens method
- Chart testing at appropriate focal distances (or viewing distances)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study Eye Inclusion Criteria:
- •Patients unilaterally or bilaterally implanted with a TECNIS non-toric/toric monofocal or TECNIS non-toric/toric Eyhance IOL;
- •Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws in U.S.;
- •Availability, willingness, and sufficient cognitive awareness to comply with examination procedures.
- •Adults (Minimum 22 years of age or older at the time of participation in the study);
排除标准
- •Patients within 30 days postoperative from surgery;
- •BCDVA worse than 20/32;
- •Posterior capsular opacification or other medical findings affecting best-corrected distance visual acuity (BCDVA) in the opinion of the investigator;
- •Clinically significant ocular surface disease that would affect study measurements based on investigator medical opinion;
- •Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc.);
- •Known ocular disease or pathology that, in the opinion of the investigator may affect visual acuity (macular degeneration, cystoid macular edema, diabetic retinopathy, glaucoma, retinal detachment etc.);
- •Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
研究组 & 干预措施
Testing Order
The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group.
干预措施: No intervention (Other)
结局指标
主要结局
The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group.
时间窗: One day Visit study
The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group.
次要结局
未报告次要终点
研究者
研究点 (4)
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