Effectiveness of Dry Eye Treatment With Diquafosol Sodium 3% After Phaco Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in OSDI score
研究概览
简要总结
The goal of this observational study is to evaluate the effectiveness of diquafosol sodium 3% in patients undergoing phacoemulsification surgery and having dry eye 1 week after the surgery. The main question it aims to answer is whether using diquafosol will help improve symptoms and signs of dry eye in patients after phaco surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing phacoemulsification surgery with IOL implantation
- •Diagnosis with grade 1, grade 2 or grade 3 dry eye one week after the surgery according to DEWS 2007 classification and Sullivan's severity grading scheme
排除标准
- •Patients with grade 3 or 4 dry eye before phaco surgery
- •Phaco surgery with complications during or after surgery
- •Patients with other eye surgeries within 6 months before phaco surgery
- •Patients who are using other eye drops before phaco surgery, except artificial tears
- •Patients with acute eye infections
- •Patients who do not return for follow-up appointments
- •Patients who do not comply with treatment
- •Patients having allergy with diquafosol 3%
- •Patients having side effects with diquafosol 3% and do not want to continue using the drug
研究组 & 干预措施
Patients undergoing phacoemulsification surgery and having dry eye 1 week after the surgery
干预措施: Diquafosol Sodium 3% (Drug)
结局指标
主要结局
Change in OSDI score
时间窗: From starting diquafosol (baseline) to 12 weeks
Change in OSDI score after treatment with diquafosol from baseline (1 week after surgery) to 4 weeks, 8 weeks, 12 weeks. At the preoperative and postoperative examinations, patient will be evaluated dry eye symptoms according to the OSDI questionnaire (from 0-100 points)
Change in Tear film breakup time (TBUT) score
时间窗: From starting diquafosol (baseline) to 12 weeks
Change in tear film breakup time (TBUT) score after treatment with diquafosol from baseline (1 week after surgery) for 4 weeks, 8 weeks, 12 weeks. At the preoperative and postoperative examinations, patient will be evaluated tear film breakup time which is measured after fluorescein staining. At each examination, TBUT score is measured 3 times to calculate the average value.
次要结局
- Change in Schirmer I test value(From starting diquafosol (baseline) to 12 weeks)
- Change in Tear meniscus height(From starting diquafosol (baseline) to 12 weeks)
- Change in Corneal staining score(From starting diquafosol (baseline) to 12 weeks)
- Change in Conjunctival staining score(From starting diquafosol (baseline) to 12 weeks)
- Change in Tear film breakup pattern(From starting diquafosol (baseline) to 12 weeks)
研究者
Le Xuan Cung
Head of Cornea Department
Vietnam National Eye Hospital