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临床试验/NCT00735865
NCT00735865已完成不适用

Lid Margin And Conjunctival Microbial Flora Following Punctum Occlusion

Lahey Clinic4 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2003年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Lahey Clinic
入组人数
55
试验地点
4
主要终点
Impact of punctal occlusion on the ocular microbial flora

研究概览

简要总结

To determine if the types and amount of bacteria or other germs change over time after the routine procedure of blockage of tear drainage duct in the treatment of dry eye condition or other condition benefiting from a tear drainage blockage

详细描述

This study will investigate the impact of punctal occlusion on the ocular microbial flora. Current thought is that punctal occlusion causes retention of inflammatory mediators on the ocular surface which may produce pathology, we hypothesize that blockage of the nasolacrimal drainage system may allow colonization of the ocular surface by potentially pathogenic ubiquitous organisms (which may produce exotoxins and other biologic products) that may be responsible for signs and symptoms seen in some patients. Additionally, the presence of the silicone foreign body(punctal plug) may act as a nidus for bacterial adhesion with biofilm production (which is known to occur with Pseudomonas sp and other organisms). There would thus be a paradigm shift of our current understanding of the pathophysiology of punctal occlusion. Additionally, the choice of antimicrobials for the treatment of infections in patients with punctal occlusion may need to be modified if the microbial flora is found to be different in patients with punctal occlusion.

The ocular flora may be different inpatients with severe dry eye or other chronic pathologic conditions, which are frequent indications for punctal occlusion. However, from our retrospective review, we could not determine if there was a change in the microbial flora following plug placement with colonization with these "unusual organisms" since baseline cultures prior to punctal plug placement were not obtained.

We will try to differentiate any effect on the microbial flora caused by the silicone plug or acrylic plug(as a foreign body) versus the punctal closure by thermocautery. (Punctal thermocauterization is an alternative method of punctal closure which is 1) the preferred choice by some ophthalmologists for all their cases, or 2) when the dry eye is severe and irreversible punctal occlusion is desired or 3) if punctal plugs can not be retained due to the large size of the patients punctal). The thermodynamic hydrophobic acrylic plug(SmartPLUG) approved by the FDA for punctal occlusion with the same indications as the traditional silicone plug.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • 18 years and older
  • Able to sign Informed Consent
  • Clinical indication for punctal plug insertion or punctal cautery or symptomatic patients who have previously had punctal occlusion
  • Clinical indication for punctal plug removal(Partial extrusion, discomfort) increased signs of ocular irritation with punctate keratopathy, punctal inflammation).
  • Able to make follow up visit schedule

排除标准

  • Subjects without dry eye

结局指标

主要结局

Impact of punctal occlusion on the ocular microbial flora

时间窗: 1 year(3mo, 6mo, 12 mo culture/follow up visits)

次要结局

未报告次要终点

研究者

发起方
Lahey Clinic
申办方类型
Other

研究点 (4)

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