Lid Margin And Conjunctival Microbial Flora Following Punctum Occlusion
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00735865|
Recruitment Status : Completed
First Posted : August 15, 2008
Last Update Posted : May 25, 2009
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndrome||Procedure: Punctal plugs, punctal cautery Procedure: Punctal Plug, Punctal thermocauterization Procedure: Silicone plug or thermodynamic hydrophobic acrylic plug Other: Previous subjects with Punctal occlusion||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lid Margin And Conjunctival Microbial Flora Following Punctum Occlusion|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||May 2009|
|Active Comparator: 1||
Procedure: Punctal plugs, punctal cautery
25 subjects(20 silicone punctal plugs, 5 punctal cautery) The procedure will be based on clinical indication. Randomized one eye for study. Baseline cultures of lid margin & tarsal/inferior fornix conjunctiva obtained & plated according to protocol
|Active Comparator: 2||
Procedure: Punctal Plug, Punctal thermocauterization
Up to 5 subjects. Subjects in need of punctal occlusion(No preference for punctal thermocauterization or punctal occlusion by silicone plug). Randomize one eye to silicone punctal plug occlusion, the other eye to punctal thermocauterization.
This group ONLY, cultures will be obtained of the lid margin & conjunctiva/inferior fornix of BOTH eyes
|Active Comparator: 3||
Procedure: Silicone plug or thermodynamic hydrophobic acrylic plug
Up to 5 subjects. Subjects in need of punctal occlusion(not preference for punctal occlusion by silicone plug or by the thermodynamic hydrophobic acrylic plug). Randomize one eye to silicone punctal plug occlusion, the other eye to acrylic punctal plug occlusion.
In this group ONLY cultures will be obtained of the lid margin and conjunctiva/inferior fornix of BOTH eyes
|Active Comparator: 4||
Other: Previous subjects with Punctal occlusion
Up to 20 subjects(15 subjects with silicone punctal plug closure and 5 subjects with punctal closure by thermocauterization)Subjects who have previously had punctal occlusion who have symptoms and/or signs thought to be secondary to punctal occlusion.
Lid margin and conjunctiva/inferior fornix of eye with greatest sign or symptoms will be cultured/plated according to standard protocol.
- Impact of punctal occlusion on the ocular microbial flora [ Time Frame: 1 year(3mo, 6mo, 12 mo culture/follow up visits) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735865
|United States, Massachusetts|
|Lahey Clinic, Inc.|
|Burlington, Massachusetts, United States, 01805|
|Lahey Clinic North|
|Peabody, Massachusetts, United States, 01960|
|Principal Investigator:||Sarkis H. Soukiasian, M.D.||Lahey Clinic, Inc.|