Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and need for prescribing anti-inflammatory topical drops to patients undergoing laser peripheral iridotomy.
详细描述
Primary closed angle glaucoma is responsible to almost half glaucoma related blindness around the world. Laser peripheral iridotomy (LPI) is a common and simple treatment used for both treatment and prevention of acute angle closure event.
Anti-inflammatory drops are commonly prescribed to patients undergoing LPI in order to prevent or reduce post-treatment discomfort. However, to date, there are no specific guidelines for post LPI anti-inflammatory treatment, nor sufficient clinical evidence regarding the efficacy of such treatment.
In the current study, the investigators aim to evaluate the effect of topical steroids and non-steroidal anti-inflammatory drugs (NSAIDs) on post LPI symptoms and inflammation markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary narrow/closed angle by gonioscopy
- •Able to give consent
- •Ability to attend follow-up visits
排除标准
- •Corneal disease preventing sufficient evaluation of the angle
- •Secondary closed angle (e.g. uveitis related)
- •Pregnant women
- •Previous eye surgery other than laser refractive correction
研究组 & 干预措施
NSAIDs-Placebo
Will receive Nepafenac 0.1%in the first eye, and Hydroxyethylcellulose 0.19% in the second eye
干预措施: Nepafenac 0.1% (Drug)
NSAIDs-Placebo
Will receive Nepafenac 0.1%in the first eye, and Hydroxyethylcellulose 0.19% in the second eye
干预措施: Hydroxyethylcellulose 0.19% (Drug)
Placebo-NSAIDs
Will receive Hydroxyethylcellulose 0.19% in the first eye, and Nepafenac 0.1%in the second eye
干预措施: Nepafenac 0.1% (Drug)
Placebo-NSAIDs
Will receive Hydroxyethylcellulose 0.19% in the first eye, and Nepafenac 0.1%in the second eye
干预措施: Hydroxyethylcellulose 0.19% (Drug)
Steroid-Placebo
Will receive Dexamethasone Disodium Phosphate 0.1% in the first eye, and Hydroxyethylcellulose 0.19% in the second eye
干预措施: Dexamethasone Disodium Phosphate 0.1% (Drug)
Steroid-Placebo
Will receive Dexamethasone Disodium Phosphate 0.1% in the first eye, and Hydroxyethylcellulose 0.19% in the second eye
干预措施: Hydroxyethylcellulose 0.19% (Drug)
Placebo-Steroids
Will receive Hydroxyethylcellulose 0.19%in the first eye, and Dexamethasone Disodium Phosphate 0.1%in the second eye
干预措施: Dexamethasone Disodium Phosphate 0.1% (Drug)
Placebo-Steroids
Will receive Hydroxyethylcellulose 0.19%in the first eye, and Dexamethasone Disodium Phosphate 0.1%in the second eye
干预措施: Hydroxyethylcellulose 0.19% (Drug)
结局指标
主要结局
Pain score
时间窗: At four days post LPI treatment
Using VAS pain scale
Symptoms score
时间窗: At four days post LPI treatment
Using a modified questionnaire based on the ocular surface disease index.
次要结局
- Grading of cells in the anterior chamber(At four days post LPI treatment)
- Patency of LPI by visualisation(up to 30 days post LPI treatment)
- Grading of flare in anterior chamber(At four days post LPI treatment)