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临床试验/NCT04318652
NCT04318652已完成4 期

The Role of Anterior Segment Optical Coherence Tomography in Management of Acquired Punctal Stenosis

Tanta University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年9月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
80
试验地点
1
主要终点
punctal opening

研究概览

简要总结

This is a clinical trial study that was conducted on patients with punctal stenosis.We studied the diameter of stenosed puncta before and after treatment with preserved free steroid eye drops using AS-OCT.

详细描述

The study was conducted on 40 eyes of 24 patients have acquired inflammatory punctal stenosis and 20 eyes of 10 patients of normal asymptomatic subjects as control group. We studied the external punctal diameter, visibility of the internal punctum and punctal depth before treatment using AS-OCT, and then patients were re-evaluated after one month of treatment with preservative free methylprednisolone 5% eye drops.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients have acquired inflammatory punctum stenosis complaining of epiphora of different etiologies.

排除标准

  • Previous lacrimal surgery.
  • Lid margin malposition such as ectropion, entropion or lid retraction.
  • Medial lid masses obscuring punctum.
  • History of ocular trauma involving lid margin or punctum.

研究组 & 干预措施

Methylprednisolone eye drops

Other

Preservative free steroids methylprednisolone 5% eye drops (prepared by dilution of methyleprednisolone 500mg in 10 ml distilled water (Solu-Medrol, Pfizer company) was prepared and given for all enrolled cases by the following regimen 5 times/day for 5 days with gradual decrease every third day over the following 2 weeks

干预措施: Methylprednisolone eyedrops (Drug)

distilled water eyedrops

Placebo Comparator

Distilled water eyedrops instilled 3 times per day for two weeks

干预措施: Methylprednisolone eyedrops (Drug)

结局指标

主要结局

punctal opening

时间窗: one month

evaluation of punctalopening by OCT

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Mahmoud Awara

assistant professor of ophthalmology

Tanta University

研究点 (1)

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