NCT07648095招募中不适用
Evaluation of Lacrifill™ Canalicular Filler for Optimization of Ocular Surface Parameters and Biometric Precision in Prospective Cataract Surgery Patients With Dry Eye Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Mean absolute error (MAE)
研究概览
简要总结
This is a single-site observational study designed to evaluate the efficacy of Lacrifill™ canalicular filler in optimizing ocular surface parameters and biometric precision in prospective cataract surgery patients with dry eye disease (DED).
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 40 years
- •Diagnosed dry eye (OSDI >= 13, TBUT < 10 sec, or Oxford staining >= Grade 2)
- •No recent ocular surgeries (<6 months)
- •No significant changes in DED regimen within last 1 month
排除标准
- •Previous punctal plugs or canalicular cautery
- •Active ocular inflammation or corneal pathology unrelated to DED
研究组 & 干预措施
Lacrifill Canalicular Filler
Observational Study
干预措施: Lacrifill Canalicular Filler (Device)
结局指标
主要结局
Mean absolute error (MAE)
时间窗: 1 month postoperatively
Difference in mean spherical equivalent Mean Absolute Error (MAE) between actual postoperative manifest refraction spherical equivalent and back-calculated equivalent based on baseline biometry.
次要结局
- Postoperative uncorrected visual acuity (logMAR)(1 month postoperatively)
- Difference in mean magnitude of postoperative refractive astigmatism(1 month postoperatively)
- Lens type candidacy(Preoperative assessment)
- Subjective visual satisfaction(1 month postoperatively)
研究者
研究点 (1)
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