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Lacrimal Drainage Resistance Study (LDRS)

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ClinicalTrials.gov Identifier: NCT01766232
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : February 19, 2015
Sponsor:
Information provided by (Responsible Party):
Julian Perry, The Cleveland Clinic

Brief Summary:

Epiphora, or uncontrolled tearing of the eyes, represents a common presenting complaint of patients seen by ophthalmologists. Epiphora may be due to non-obstructive causes, such as tear hypersecretion or functional tear pump failure, or obstructive causes. Functional tear pump failure may result from malposition of the eyelids, such as an abnormal out-turning (ectropion) or in-turning (entropion) of the eyelid.

Currently methods to diagnose partial nasolacrimal duct obstruction are purely qualitative in nature. Our research goal is to quantitatively measure the pressure generated during conventional probing and irrigation (P&I), and to measure the resistance to irrigation of the nasolacrimal drainage system.

The investigators will measure the pressure generated during conventional P&I using a disposable in-line pressure transducer. In addition, the investigators will use a syringe pump to deliver a constant flow rate of saline through a nasolacrimal cannula and measure the steady state irrigation pressure using the in-line transducer and digital pressure monitor. Resistance can be directly calculated from the known flow rate and pressure measurements.

The investigators will compare both the pressure generated during P&I and the lacrimal drainage resistance between patients with lacrimal drainage obstruction and controls patients with no obstruction (functional tear pump failure) as determined by clinical exam.

Clinical applications for measuring lacrimal drainage resistance include quantifying partial nasolacrimal duct obstruction, guiding the choice of surgical procedure, and determining the success of lacrimal drainage procedures.


Condition or disease
Epiphora Nasolacrimal Duct Obstruction Canalicular Stenosis Functional Tear Pump Failure Ectropion

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 40 participants
Time Perspective: Prospective
Official Title: Lacrimal Drainage Resistance Study
Study Start Date : April 2009
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Group/Cohort
Obstructed nasolacrimal drainage group
This group of patients is clinically identified as having epiphora due to an obstruction of the lacrimal drainage system.
Ectropion group
This group of patients is clinically determined to have functional epiphora due to ectropion and a patent lacrimal drainage system.



Primary Outcome Measures :
  1. Lacrimal drainage resistance [ Time Frame: one-time clinical measurement ]

Secondary Outcome Measures :
  1. Pressure generated during nasolacrimal duct irrigation [ Time Frame: one-time clinical measurement ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the oculoplastics service with epiphora.
Criteria

Inclusion Criteria:

  • Adult patients (18 years and older) who present for evaluation of epiphora due to obstructed causes, and control patients who present for evaluation of epiphora due to non-obstructed functional causes, who have been recommended for traditional probing and irrigation

Exclusion Criteria:

  • Active infection
  • Punctal stenosis

Information from the National Library of Medicine

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): NCT01766232


Locations
United States, Ohio
Cleveland Clinic Cole Eye Institute
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Julian D Perry, MD Cleveland Clinic Cole Eye Institute
Principal Investigator: Brian Costin, MD The Cleveland Clinic