跳至主要内容
临床试验/CTRI/2025/05/087123
CTRI/2025/05/087123尚未招募Phase 3 4

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

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年6月15日最近更新:

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

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Srashti Jain

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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