Outcome of Concomitant Use of Punctal Plugs and Omeg 3 Fatty Acids on Ocular Surface Disease in Patients Using Systemic Isotretinoin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Break up Time at baseline and during the study
研究概览
简要总结
Ocular surface disease is a common adverse effect of systemic isotretinoin therapy.
The investigators consider that punctal plugs and Omega 3 is a good line for treatment of ocular surface disease associated with systemic isotretinoin therapy
详细描述
Subjective and objective evaluation of ocular surface disease was done at baseline ,1 and 3 months of the study .
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •systemic isotretinoin therapy
排除标准
- •systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearer
研究组 & 干预措施
punctal plug
SOFT PLUG® Preloaded Silicone Plugs by OASIS®
干预措施: punctal plug (Device)
Combined
SOFT PLUG® Preloaded Silicone Plugs by OASIS® plus Daily intake of DHA (docosahexaenoic acid)
干预措施: Omega 3 (Drug)
Combined
SOFT PLUG® Preloaded Silicone Plugs by OASIS® plus Daily intake of DHA (docosahexaenoic acid)
干预措施: punctal plug (Device)
结局指标
主要结局
Change in Break up Time at baseline and during the study
时间窗: 3 months
fluorescein sodium stripes will be used for measurement of Break up Time in seconds
次要结局
未报告次要终点
研究者
Tarek Roshdy mohamed Mahgoub ELhamaky
lecturer of ophthalmology
Benha University