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临床试验/NCT06798025
NCT06798025已完成不适用

Comparative Study Between Three Different Modalities for Treatment of Inflammatory Punctal Stenosis

Tanta University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年7月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Degree of patient satisfaction

研究概览

简要总结

This study aimed to compare the efficacy of three various modalities of treatment of inflammatory punctal stenosis (Punctal dilatation alone, combined punctal dilatation with topical medications, or peri-punctal injection of Triamcinolone acetonide)

详细描述

Acquired punctal stenosis is a condition in which the external opening of the lacrimal canaliculus, located in the nasal part of the palpebral margin, is narrowed or occluded. This condition results from chronic inflammation of the external punctum, leading to gradual fibrotic changes in the ostium, followed by progressive occlusion of the duct.

Different modalities were described for the treatment of acquired punctual stenosis. Repeated dilatation of the stenotic punctum is a simple procedure that may provide temporary improvement of the symptoms, but restenosis is common unless additional procedures are performed. Many other methods were used to augment punctual size, including 1-snip, 2-snip, and 3-snip punctoplasty, supplemented with adding sutures or Mini-Monoka insertion and punch punctoplasty.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
33 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 33 to
  • Both sexes.
  • Patients with inflammatory punctal stenosis or occlusion complaining of symptomatic epiphora.

排除标准

  • Subjects with previous lacrimal surgeries.
  • Subjects with lid margin malposition such as ectropion, entropion, or lid retraction.
  • Subjects with medial lid masses obscuring the punctum.
  • Subjects with a history of ocular trauma involving the medial aspect of the lid margin.

研究组 & 干预措施

Group A

Experimental

Patients were treated with punctal dilatation only

干预措施: Punctal dilation (Procedure)

Group B

Experimental

Patients were treated with a combination of punctual dilation and topical medication in the form of preservative-free steroid eye drops based on dexamethasone sodium phosphate (0.1%) and preservative-free artificial tears based on sodium hyaluronate, polyethylene, and propylene Glycol.

干预措施: Punctal dilation and topical medication (Drug)

Group C

Experimental

Patients were treated with a peri-punctual injection of Triamcinolone acetonide.

干预措施: Triamcinolone acetonide (Drug)

结局指标

主要结局

Degree of patient satisfaction

时间窗: 3 months postoperatively

The degree of patient satisfaction was assessed using 3-point Likert Scale (1=Not satisfied, 2: No Difference, 3:Satisfied)

次要结局

  • Punctal diameter(3 months postoperatively)

研究者

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

Yomna EL-Saied Mohamed Ibrahim

Resident of Ophthalmology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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