To compare visual outcome, post-operative inflammation and Cystoid macular edema in Early v/s late initiation of NSAIDs
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Improvement in visual acuity
研究概览
简要总结
Post operative inflammation and Cystoid Macular Edema
(CME) are common complications following cataract surgery. Corticosteroids and Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs) are commonly used to treat them. This study aims to compare
these complications after surgery with administration of the above mentioned two drugs. Patients
will be divided in two groups- Group 1 will receive topical Nepafenac 0.1% thrice daily for 1 month from
postoperative day 1. Group 2 will receive topical Nepafenac 0.1% thrice daily for 1 month starting 3 weeks
postoperatively. All participants will receive topical Dexamethasone 0.1% 6 times a day for 1 week, 4 times a
day for the next week, and then tapered 1 drop per week over the next 3 weeks from post operative day 1.
Both groups will be compared to look for post operative inflammation, CME and visual acuity after the
surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Visually significant cataract Uneventful phacoemulsification with IOL implantation.
排除标准
- •Diabetic retinopathy and other retinal pathologies 2)History of uveitis.
- •Mature, hyper mature, traumatic, complicated cataract.
- •Known or suspected hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) 5) Cystoid macular edema in the fellow eye.
- •Vascular occlusive disorders.
- •Associated Macular pathologies 8)Pregnant and lactating women 9) Patients with mental illness 10)Non visualization of fundus 11) H/O steroid responsiveness 12) H/O Prostaglandin analog usage 13) Dry eye.
结局指标
主要结局
Improvement in visual acuity
时间窗: 1 year
次要结局
- 1)Reduced incidence of post operative inflammation.(2)Reduced incidence of CME on late initiation of prophylactic NSAID therapy.)
研究者
Dr.Mithila Pravin Joshi
Aravind Eye Hospitals , Chennai