NCT06085131已完成不适用
Accuracy of the New Barrett TAL Formula With the Argos Measurements: A Multicenter Prospective Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 523
- 试验地点
- 12
- 主要终点
- The percentage of eyes that achieve a postoperative manifest spherical equivalent refraction ≤ ±0.50 D.
研究概览
简要总结
This study is a prospective, multi-site, multi-surgeon, observational study of refractive accuracy with the Argos using BTAL after successful cataract surgery. Subjects will be assessed pre-operatively, operatively and at 5-8 weeks postoperatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and preoperative biometry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are eligible for the study if they meet the following criteria:
- •Cataract surgery that was completed without complications with biometry measured using the Argos biometer.
- •Subjects that elect Clareon SY60WF aspheric lens (Alcon, Fort Worth, TX).
- •Potential post-operative visual acuity of better than logMAR 0.30 (20/40).
- •BTAL was used to determine the IOL power implanted.
排除标准
- •If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- •Patients with pre-existing ocular pathology that in the opinion of the principial investigator would influence the postoperative refraction.
- •Any disease or pathology, including but not limited to irregular corneal astigmatism and keratoconus, that is expected to reduce the potential postoperative BCDVA to a level worse than 20/
- •Patients with history of previous ocular surgery.
- •Patients with signs of inability to understand consent for study and procedure planned.
- •Eyes with intraoperative or postoperative complications.
- •Suboptimal surgical outcomes that are not related to the treatment plan, e.g. capsular tear, cystoid macular edema.
- •Astigmatism >±0.75D.
- •Each investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- •Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
结局指标
主要结局
The percentage of eyes that achieve a postoperative manifest spherical equivalent refraction ≤ ±0.50 D.
时间窗: 2 months postoperative
次要结局
- The Mean Predictive Error and its standard deviation after constant personalization for the entire series.(2 months postoperative)
- The Mean Predictive Errors in the short eyes and in the long eyes(2 months postoperative)
- The percentage of eyes that achieve a postoperative manifest spherical equivalent refraction ≤ ±0.250D, ≤ ±0.75D and ≤ ±1.00D.(2 months postoperative)
研究者
研究点 (12)
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