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
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|
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Lacrimal Drainage Resistance Study|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Obstructed nasolacrimal drainage group
This group of patients is clinically identified as having epiphora due to an obstruction of the lacrimal drainage system.
This group of patients is clinically determined to have functional epiphora due to ectropion and a patent lacrimal drainage system.
- Lacrimal drainage resistance [ Time Frame: one-time clinical measurement ]
- Pressure generated during nasolacrimal duct irrigation [ Time Frame: one-time clinical measurement ]
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
|United States, Ohio|
|Cleveland Clinic Cole Eye Institute|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Julian D Perry, MD||Cleveland Clinic Cole Eye Institute|
|Principal Investigator:||Brian Costin, MD||The Cleveland Clinic|