0.1% Nepafenac vs 0.09% Bromfenac Eye Drops in Post Laser Peripheral Iridotomy Inflammation- A Randomised Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- To compare the anterior chamber inflammation control between 0.1% Nepafenac eye drops and 0.09% Bromfenac eye drops
研究概览
简要总结
The study is a Randomised , single blind , parallel group trial comparing the safety and efficacy between the two Non-steroidal anti-inflammatory eye drops -0.1% Nepafenac and 0.09% Bromfenac eye drops in patients undergoing Nd-YAG peripheral iridotomy conducted at a centre in India.
Patients will be randomised into 2 groups following YAG Peripheral iridotomy by computer generated random number to either 0.1% Nepafenac group using drops 3 times/day for 2 weeks or 0.09% Bromfenac group using drops twice daily for 2 weeks.
At 2 weeks review, anterior chamber inflammation is graded using Standardised uveitis nomenclature grading group and comfort levels assessed using Glaucoma symptom scale questionnaire.
The primary outcome measure is to compare the inflammation control between the two groups at 2 weeks
The secondary outcome measure is to compare the comfort level of the patients of the two groups by using questionnaire .
Expected outcome-
-
The study will help us to find out the best NSAID drop in terms of inflammation control
-
This will help us to give the best possible treatment to the patients following laser iridotomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Primary angle closure suspects 2)Primary angle closure not started in anti-glaucoma medications post laser peripheral iridotomy 3)Best corrected visual acuity of 6/12 or better.
排除标准
- •Corneal pathology like dry eyes 2)Significant cataract which is obscuring undilated disc evaluation 3)PAC patients who are started on glaucoma medication before or immediately after LPI 4)PACG and Secondary angle closure glaucoma 5)History of any topical therapy including NSAID’s within the past 30 days prior to LPI 6)Patient on systemic steroids or non-steroidal anti-inflammatory drugs 7) Any History of Laser or intraocular surgery 8)Pregnant or nursing mothers 9)Monocular patients 10)Any evidence of uveitis (old or new) 11) Patients with bleeding in the eye after the LPI.
结局指标
主要结局
To compare the anterior chamber inflammation control between 0.1% Nepafenac eye drops and 0.09% Bromfenac eye drops
时间窗: 2 weeks
次要结局
- 1)To compare the comfort level of patients between the 0.1% Nepafenac and 0.09% Bromfenac groups by questionnaire (Glaucoma symptom scale questionnaire)(2) To assess any adverse reaction to the two drops in prescribed dosage)