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Lid Margin And Conjunctival Microbial Flora Following Punctum Occlusion

NCT00735865 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2009-05-25

No results posted yet for this study

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

Conditions

  • Dry Eye Syndrome

Interventions

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

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

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

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.

Sponsors & Collaborators

  • Lahey Clinic

    lead OTHER

Principal Investigators

  • Sarkis H. Soukiasian, M.D. · Lahey Clinic, Inc.

Study Design

Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2009-04-30
Completion
2009-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00735865 on ClinicalTrials.gov