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Lacrimal Drainage Resistance Study (LDRS)

This study has been completed.
Information provided by (Responsible Party):
Julian Perry, The Cleveland Clinic Identifier:
First received: May 13, 2011
Last updated: February 17, 2015
Last verified: February 2015

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.

Epiphora Nasolacrimal Duct Obstruction Canalicular Stenosis Functional Tear Pump Failure Ectropion

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Lacrimal Drainage Resistance Study

Resource links provided by NLM:

Further study details as provided by Julian Perry, The Cleveland Clinic:

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

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

Enrollment: 40
Study Start Date: April 2009
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
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.

  Show Detailed Description


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01766232

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