Study to evaluate effectiveness of prophylactic topical nepafenac 0.1 percentage in maintaining transoperative mydriasis and preventing post operative macular edema in topical phacoemulsification cataract surgery
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- We expect significant results/outcomes that in order to maintain transoperative mydriasis & avoid post-operative macular edema following cataract surgery, prophylactic tropical nepafenac is likely to be useful
研究概览
简要总结
Following standard cataract surgery, impairment of vision may result from post-operative cystoid macular oedema (CMO). The purpose of the research is to assess the efficacy of preventive topical nepafenac (0.1%) in preventing post-operative macular edema following phacoemulsified cataract surgery & in preserving transoperative mydriasis. This 2-year study where the patients reporting to the Department OPD of Ophthalmology, undergoing the phacoemulsification cataract surgery will be part of the research. The study include 38 patients (two groups) & the study type is prospective, randomized, single-masked comparative study. For topical mydriatic usage, each treatment group will receive two doses of tropicamide 0.8% & phenylephrine 5% every fifteen minutes. Moreover, the nepafenac group received 4 doses starting an hour before surgery at a rate of only one drop once every fifteen minutes. Following surgery, all patients had a 4-week tapering period after receiving topical corticosteroid-antibiotic therapy (prednisolone + moxifloxacin) once for one hour for 15 days. One drop of nepafenac will be administered three times a day to the participants in the group being studied (the nepafenac group) starting the day before surgery & continued for six weeks following. Postoperative evaluations will be performed on the first day & Weeks 2 & 6 after surgery for all patients. Significant findings in the effectiveness of prophylactic tropical nepafenac is expected in the maintenance of transoperative mydriasis & prevention of post operative macular edema in the cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Diagnosed with senile and/or metabolic cataract.
- •Scheduled for surgery by phacoemulsification.
- •patient With a normal fundoscopy exam, if observance was possible.
排除标准
- •Pregnancy or breastfeeding.
- •History of ocular inflammatory or infectious eye disease.
- •Treatment for eye infection within 30 days prior to inclusion in the study.
- •Alterations on the eye surface, including dry eye.
- •History of ocular surgery and/or trauma.
- •Knowledge or suspicion of allergy or hypersensitivity to the preservatives, steroids, topical NSAIDs, or any other component of the study medication.
结局指标
主要结局
We expect significant results/outcomes that in order to maintain transoperative mydriasis & avoid post-operative macular edema following cataract surgery, prophylactic tropical nepafenac is likely to be useful
时间窗: Assessment will be done after one and half months.
次要结局
未报告次要终点
研究者
Dr Srashti Jain
Datta Meghe Institute of Higher Education and Research
