A Prospective, Randomized Study to Compare the Safety and Efficacy of Topical 0.1% Nepafenac Eye Drops with Topical 1% Prednisolone Acetate Eye Drops in Primary Angle Closure Suspects Undergoing YAG Peripheral Iridotomy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- To compare level of anterior chamber inflammation control between 0.1% Nepafenac and 1% Prednisolone acetate groups.
研究概览
简要总结
This study is a randomized, double blind, parallel group trial comparing the safety and efficacy of topical 0.1% Nepafenac eye drops with topical 1% Prednisolone acetate eye drops in primary angle closure suspects undergoing Nd:YAG peripheral iridotomy conducted at one centre in India. The primary outcome measure was level of anterior chamber inflammation control at 2 and 4 weeks between the two groups. The secondary outcome measure was change in IOP at 2 and 4 weeks between the two groups.
Results:
1. Both the groups were comparable in age and gender distribution. The higher number of females in study population is consistent with the finding that females are at higher risk for primary angle closure disease.
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There was no significant difference in inflammation control between the two groups
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The difference in mean IOP from baseline was significantly higher in Prednisolone group (p-value <0.001) at 2 weeks follow up where as it was insignificantly higher in Prednisolone group at 4weeks follow up.
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Recurrent iritis was seen in 4 (5.8%) patients in Prednisolone group within 2 days after stopping steroid eye drops.
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At 2 weeks, Nd:YAG iridotomy was repeated in 8 patients in Prednisolone group, but none in Nepafenac group needed repeat YAG iridotomy.
Conclusion: Topical Nepafenac 0.1% eye drop is as effective as topical Prednisolone acetate 1% eye drop in controlling inflammation after Nd:YAG peripheral iridotomy, with lesser side effects like intraocular pressure elevation, recurrent iritis and closure of iridotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Best corrected visual acuity 6/9 or more
- •Primary angle closure suspects.
排除标准
- •Corneal pathology
- •Significant cataract (obscuring undilated fundus view)
- •Intra ocular pressure more than 21 mm of Hg
- •Peripheral anterior synechiae
- •History of use of topical or systemic steroids one month prior to laser iridotomy
- •History of use of topical or systemic NSAIDS one month prior to laser iridotomy.
结局指标
主要结局
To compare level of anterior chamber inflammation control between 0.1% Nepafenac and 1% Prednisolone acetate groups.
时间窗: 2 weeks and 4 weeks post laser
次要结局
- To compare the changes in IOP between 0.1% Nepafenac and 1% Prednisolone acetate groups.(2 weeks and 4 weeks post laser)