A Study of the Effect of Different Doses of Difluprednate Eye Drops on the Intraocular Pressure After Phacoemulsification
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Anterior chamber examination for flare and cell
研究概览
简要总结
The study aims at detecting the minimum effective daily dose and duration of difluprednate that can be used to treat postoperative inflammation after phacoemulsification without increasing the intraocular pressure, and whether it can be safely given within the first 24 hours after the operation.
详细描述
Conventional phacoemulsification will be performed by the same surgeon for all the cases using the stop and chop technique. Anterior chamber examination for flare and cells using slit-lamp biomicroscopy according to the SUN recommendations and intraocular pressure measurement using Goldmann applanation tonometer will be done for all the cases before surgery and on the 1st, 3rd, 7th, 14th days as well as one month after the procedure.
All cases will receive Nepafenac 0.1% ( Nevanac 0.1%) 3 times per day on the last preoperative day, one tablet of Acetazolamide 250 mg (Cidamex 250mg) within the first 3 hours after the procedure and Moxifloxacin (Vigamox 0.5%) 0.1 ml intracameral and post-operative drops 3 times per day for 10 days and will be divided into:
In this pilot study:
- Group A : will receive Difluprednate 4 times per day for 1 week, then twice per day for 1 week and then once per day for 5 days starting 24 hours after the operation
- Group B : will receive Difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-80
- •Grade 1 to 4 nuclear cataract LOCS II
- •Cumulative dissipated energy CDE 1 to 10
- •Done by a single surgeon using the chopping technique
排除标准
- •History of uveitis
- •the use of topical or systemic steroids on the last post-operative day
- •Intraoperative or postoperative complications
- •Intraoperative iris manipulations or phaco traume
研究组 & 干预措施
Group A
will receive Difluprednate 4 times per day for 1 week, then twice per day for 1 week and then once per day for 5 days starting 24 hours after the operation
干预措施: Difluprednate Eye Drops (Drug)
Group B
will receive Difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation
干预措施: Difluprednate Eye Drops (Drug)
结局指标
主要结局
Anterior chamber examination for flare and cell
时间窗: 3 months
using SUN classification
次要结局
未报告次要终点
研究者
Ahmed Hashiem
Lecturer of ophthalmology ,ophthalmology consultant
Kafrelsheikh University