Pain Expression in the Perioperative Period of Cataract Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Post operative pain level
研究概览
简要总结
Patients having cataract extraction in the second eye under topical anesthesia with monitored anesthesia care often report increased pain and awareness relative to the first surgery in the fellow eye, despite similar operative and anesthetic conditions. The purpose of this study is to investigate the pathogenesis of this phenomenon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age-related cataract patients aged 50 years or older able to give informed consent undergoing cataract surgery;
- •Pupil dilation ≧7 mm after mydrisis;
- •VA prognosis ≧6/12
排除标准
- •Unable to give informed consent;
- •Patients with history of ocular pathology or diabetic retinopathy;
- •Patients with traumatic, subluxated and posterior polar cataract;
- •Patients had other ocular surgery (not cataract surgery) in the past 6 months;
- •Patients with significant intra-operative complications
研究组 & 干预措施
Steroids eye drops
Dexamethasone eye drop, 1 drop, qid, for 3 days before surgery
干预措施: Second eye (SE) (Procedure)
Steroids eye drops
Dexamethasone eye drop, 1 drop, qid, for 3 days before surgery
干预措施: First eye (FE) (Procedure)
First eye (FE)
Phacoemulsification cataract extraction surgery of first eye
干预措施: First eye (FE) (Procedure)
First eye (FE)
Phacoemulsification cataract extraction surgery of first eye
干预措施: Steroids eye drops (Drug)
Second eye (SE)
Phacoemulsification cataract extraction surgery of second eye
干预措施: Second eye (SE) (Procedure)
Second eye (SE)
Phacoemulsification cataract extraction surgery of second eye
干预措施: Steroids eye drops (Drug)
结局指标
主要结局
Post operative pain level
时间窗: 3 days
Post operative pain level recorded on a VAS (0-10) at rest for the first three days after cataract surgery.
次要结局
未报告次要终点
研究者
Peng ZHOU
Secretary of EBCS Group
Evidence Based Cataract Study Group