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临床试验/CTRI/2023/03/050650
CTRI/2023/03/050650尚未招募不适用

Effect of perioperative topical nepafenac 0.3% on central macular thickness after cataract surgery in patients with diabetes: A randomized controlled trial

pondicherry institute of medical sciences1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2023年3月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
136
试验地点
1
主要终点
To determine the effect of perioperative nepafenac 0.3% on central macular thickness after uneventful cataract surgery in diabetes

研究概览

简要总结

Title of the dissertation: Effect of perioperative topical nepafenac 0.3% on central macular     thickness after cataract surgery in patients with diabetes: A randomized controlled trial

Primary objectives: To determine the effect of perioperative nepafenac 0.3% on central macular thickness after uneventful cataract surgery in diabetesSecondary objectives: To determine the association of the effect of nepafenac (0.3%) with post cataract surgery visual acuity**.**

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
40.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All diabetic patients in the age group 40yrs and above, will be undergoing routine cataract surgery.

排除标准

  • •Preexisting macular diseases/ macular oedema •Recent intraocular surgery other than cataract surgery for 3 months •Intra operative complications during the surgery •Allergic or hypersensitive to NSAIDS, corticosteroids •Chronic and recurrent inflammatory eye diseases.
  • •Use of any eye drops in last three months.
  • •Diseases causing macular edema other than diabetes are age related macular degeneration, Retinal venous occlusion, Coats disease, Radiation retinopathy, choroidal tumors and retinitis pigmentosa Other drugs like chloroquine, tamoxifen and interferon can induce macular edema.

结局指标

主要结局

To determine the effect of perioperative nepafenac 0.3% on central macular thickness after uneventful cataract surgery in diabetes

时间窗: Follow up day 1, day-7, day 28

次要结局

  • To determine the association of the effect of nepafenac (0.3%) with post cataract surgery visual acuity.(Follow up day 1, day-7, day 28)

研究者

申办方类型
Private medical college

研究点 (1)

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