Topical 0,09% Bromfenac for Intraoperative Miosis and Pain Reduction in Femtosecond Laser-assisted Cataract Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- intraoperative miosis
研究概览
简要总结
To evaluate the effect of bromfenac ophthalmic solution 0.09% for reduction of intraoperative miosis and pain in patient who have undergone femtosecond laser-assisted cataract surgery.
详细描述
This prospective cross-sectional randomized clinical study included 60 patients with senile cataract in the absence of significant ocular comorbidity. The patients received 0.09% bromfenac ophthalmic solution or control placebo twice a day for 3 days before surgery. Pupil diameter was measured at the initiation and finalization of femtosecond laser-assisted cataract surgery and pain quantification was assessed by analogous pain scale at one day follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Male and female
- •Subjects 18 years or older
- •Patients scheduled for unilateral femtosecond laser-assisted cataract surgery cataract surgery with posterior chamber (PC) IOL implantation.
排除标准
- •Presence of corneal abnormalities
- •History of intraocular surgery
- •History of ocular or systematic diseases (glaucoma, diabetes, uveitis
- •Regular, systemic use of steroid or NSAIDs during the previous 3 months
研究组 & 干预措施
0,09% Bromfenac
Topical 0,09% Bromfenac twice daily 3 days before surgery
干预措施: 0,09% Bromfenac (Drug)
0,1% sodium hyaluronate
Topical 0,1% sodium hyaluronate twice daily 3 days before surgery
干预措施: 0,1% sodium hyaluronate (Drug)
结局指标
主要结局
intraoperative miosis
时间窗: 2 days
Evaluation of reduction of intraoperative miosis before and after femtosecond laser assisted cataract surgery
次要结局
- postoperative pain(1 day)
研究者
Maria Camila Aguilar Sierra
MD
Hospital de La Luz