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Lid Margin And Conjunctival Microbial Flora Following Punctum Occlusion

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Punctal plugs, punctal cautery
Punctal Plug, Punctal thermocauterization
Silicone plug or thermodynamic hydrophobic acrylic plug
Previous subjects with Punctal occlusion
Sponsored by
Lahey Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry Eye Syndrome, Punctal Occlusion, Punctal Plugs, Tear Drainage duct blockage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Subjects without dry eye

Sites / Locations

  • Lahey Clinic, Inc.
  • Lahey Clinic North

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Impact of punctal occlusion on the ocular microbial flora

Secondary Outcome Measures

Full Information

First Posted
August 13, 2008
Last Updated
May 22, 2009
Sponsor
Lahey Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00735865
Brief Title
Lid Margin And Conjunctival Microbial Flora Following Punctum Occlusion
Official Title
Lid Margin And Conjunctival Microbial Flora Following Punctum Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lahey Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
Dry Eye Syndrome, Punctal Occlusion, Punctal Plugs, Tear Drainage duct blockage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Arm Title
4
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Punctal plugs, punctal cautery
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Punctal Plug, Punctal thermocauterization
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Silicone plug or thermodynamic hydrophobic acrylic plug
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Previous subjects with Punctal occlusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Impact of punctal occlusion on the ocular microbial flora
Time Frame
1 year(3mo, 6mo, 12 mo culture/follow up visits)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Subjects without dry eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarkis H. Soukiasian, M.D.
Organizational Affiliation
Lahey Clinic, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahey Clinic, Inc.
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Lahey Clinic North
City
Peabody
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States

12. IPD Sharing Statement

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Lid Margin And Conjunctival Microbial Flora Following Punctum Occlusion

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