Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery (Topical Rimexolone Versus Topical Dexamethasone and Topical Fluorometholone)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Measuring the rise in intraocular pressure using the Tono-Pen® after topical steroids are used in children under 12 years of age, who underwent bilateral strabismus surgery
研究概览
简要总结
This study aims to compare the effects of topical (Rimexolone versus Dexamethasone) on the IOP in children under 13 years of age who underwent bilateral strabismus surgery, and to compare the effects of topical (Rimexolone versus Fluorometholone) on the IOP in the children under 13 years of age who underwent bilateral strabismus surgery.
详细描述
Children under the age of 13 years undergoing bilateral strabismus surgery in Cairo University Hospitals (Cairo University Specialized Pediatric Hospital and Kasr Al Ainy Hospital). will be randomized using simple randomization method, computer software for randomization, into two equal groups:
- First group: One eye is randomized to receive topical 0.1% Dexamethasone, whereas the fellow eye will receive topical 1% Rimexolone four times per day for 2 weeks.
- Second group: One eye is randomized to receive topical 0.1% Fluorometholone, whereas the fellow eye will receive topical 1% Rimexolone four times per day for 2 weeks.
IOP will be measured on the day before operation using the Tono-Pen®. Three reliable measurements will be obtained from each eye and the mean will be taken.
IOP will be measured at postoperative weeks 1, 2, 3, 4 and 6 using the Tono-Pen®.
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
- — 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children younger than 13 years of age.
- •Children who underwent bilateral recession strabismus surgeries.
- •Preoperative IOP of 21.00 mmHg or less, with a cup-disc ratio of 0.3 or less.
- •The absence of systemic disease and ocular disease (apart from strabismus) in both eyes.
- •Children who can comply with the IOP measurements using the Tono-Pen®, as no type of anesthesia will be used, except for the topical anesthesia.
排除标准
- •Patients that are 13 years of age or older.
- •Children who need resection muscle surgeries, surgeries for the vertical, or the oblique muscles.
- •Preoperative IOP of more than 21.00 mmHg, or a cup-disc ratio of more than 0.3
- •Family history of glaucoma or high myopia.
- •A history of steroid usage in the past year.
- •Failure to comply with IOP measurements or the follow-up schedule.
研究组 & 干预措施
Group A
20 eyes that received topical 0.1% Dexamethasone 4 times per day for 2 weeks after surgery. And topical Moxifloxacin 4 times per day for 2 weeks after surgery.
干预措施: 0.1 % Dexamethasone (Drug)
Group B
20 eyes that received topical 0.1 % Fluorometholone 4 times per day for 2 weeks after surgery. And topical Moxifloxacin 4 times per day for 2 weeks after surgery.
干预措施: 0.1% Fluorometholone (Drug)
Group C
40 eyes that received topical 1% Rimexolone 4 times per day for 2 weeks after surgery. And topical Moxifloxacin 4 times per day for 2 weeks after surgery.
干预措施: 1% Rimexolone (Drug)
结局指标
主要结局
Measuring the rise in intraocular pressure using the Tono-Pen® after topical steroids are used in children under 12 years of age, who underwent bilateral strabismus surgery
时间窗: IOP will be followed up for 6 weeks after initial use
Measuring the rise in intraocular pressure using the Tono-Pen® after topical steroid use in children. IOP will be measured at postoperative weeks 1, 2, 3, 4 and 6. And will be compared with pre-operative values.
次要结局
未报告次要终点
研究者
Abeer Tawfik Al Hanaineh
Doctor Abeer Tawfik Farhan Al Hanaineh
Cairo University