Trial record 2 of 83 for:    Open Studies | "Lacrimal Apparatus Diseases"

Lacrimal Drainage Resistance Study (LDRS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
Julian Perry, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01766232
First received: May 13, 2011
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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
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 The Cleveland Clinic:

Primary Outcome Measures:
  • Lacrimal drainage resistance [ Time Frame: one-time clinical measurement ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pressure generated during nasolacrimal duct irrigation [ Time Frame: one-time clinical measurement ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: NCT01766232

Contacts
Contact: Julian D Perry, MD 216-444-3635 perryj1@ccf.org

Locations
United States, Ohio
Cleveland Clinic Cole Eye Institute Recruiting
Cleveland, Ohio, United States, 44195
Contact: Julian D Perry, MD    216-444-3635    perryj1@ccf.org   
Principal Investigator: Julian D Perry, MD         
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