A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 10
- 主要终点
- Precision (Standard Deviation) of Preoperative Keratometric Measurements
研究概览
简要总结
This is a post-market, prospective, randomized, multi-center, bilateral, open-label, cross-over, comparative clinical study. Study group will undergo preoperative LipiFlow treatment and Control group will not receive preoperative LipiFlow treatment. Three months postoperatively, both groups will be evaluated for clinical outcomes and the Control group will receive LipiFlow treatment as the cross-over group. The Control group will be evaluated at 4 months postoperative for clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Precision (Standard Deviation) of Preoperative Keratometric Measurements
时间窗: 2-4 weeks after first Pre-operative visit
Biometry testing was done pre-operatively
Rate of Refractive Predictability
时间窗: Difference between Baseline visit and Postoperative visit at 10-14 weeks after cataract surgery on the second eye.
Percentage of eyes with achieved manifest refractive spherical equivalence (MRSE) within +/- 0.50 D and +/- 1.00 D. Achieved MRSE for each eye is defined as postoperative MRSE minus targeted MRSE.
Rate of Bothersome Ocular Symptoms
时间窗: 3 months postoperative
Patient-Reported Visual Symptom Questionnaire (PRVSQ) Rating Results at 3 months postoperative
Mean Monocular UCDVA (Uncorrected Distance Visual Acuity)
时间窗: 3 months Postoperative
Uncorrected Distance Visual Acuity was measured for the Study and Control groups at the 3-month visit using the Clinical Trial Suite (M\&S Technologies) at 4.0 meters under photopic conditions (\~85 cd/m2).
Precision of Axial Length (AL) and Anterior Chamber Depth (ACD)
时间窗: 2-4 weeks after first Pre-operative visit
Biometry testing was done pre-operatively
Mean Change in Total Meibomian Gland Score From Baseline to 1 Month Postoperative
时间窗: Preoperative Visit (Baseline) and Postoperative Visit between 30-60 days after cataract surgery on the second eye.
Total Meibomian Gland Score: Fifteen Meibomian Glands (five temporally, centrally and nasally) in the lower eye are assessed on a scale of 0 - 3 (0 - No secretion, 1 - Inspissated (toothpaste consistency), 2 - Colored/cloudy liquid secretion or 3 - Clear liquid oil secretion). The sum of all 15 glands constitute the total meibomian gland secretion score (range 0-45).
次要结局
未报告次要终点