Lacrimal Drainage Resistance Study

NCT01766232 | Completed

• 1 other identifier: IRB 07-926
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Epiphora; Nasolacrimal Duct Obstruction; Canalicular Stenosis; Functional Tear Pump Failure; Ectropion

Outcome Measures

Primary Outcomes (1)

• Lacrimal drainage resistance

  one-time clinical measurement

Secondary Outcomes (1)

• Pressure generated during nasolacrimal duct irrigation

  one-time clinical measurement

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the oculoplastics service with epiphora.

You may qualify if:

• 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

You may not qualify if:

• Active infection
• Punctal stenosis

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Cole Eye Institute

Cleveland, Ohio, 44195, United States

Location

Related Publications (6)

• Kuchar A, Steinkogler FJ. Antegrade balloon dilatation of nasolacrimal duct obstruction in adults. Br J Ophthalmol. 2001 Feb;85(2):200-4. doi: 10.1136/bjo.85.2.200.

  PMID: 11159486 BACKGROUND

• Mills DM, Meyer DR. Acquired nasolacrimal duct obstruction. Otolaryngol Clin North Am. 2006 Oct;39(5):979-99, vii. doi: 10.1016/j.otc.2006.07.002.

  PMID: 16982258 BACKGROUND

• Perry JD, Maus M, Nowinski TS, Penne RB. Balloon catheter dilation for treatment of adults with partial nasolacrimal duct obstruction: a preliminary report. Am J Ophthalmol. 1998 Dec;126(6):811-6. doi: 10.1016/s0002-9394(98)00278-5.

  PMID: 9860005 BACKGROUND

• Stanley CF, Masri FA. Instrument to test patency of lacrimal drainage system. J Clin Eng. 1991 Jan-Feb;16(1):57-60. doi: 10.1097/00004669-199101000-00014.

  PMID: 10109831 BACKGROUND

• Tsirbas A, Davis G, Wormald PJ. Mechanical endonasal dacryocystorhinostomy versus external dacryocystorhinostomy. Ophthalmic Plast Reconstr Surg. 2004 Jan;20(1):50-6. doi: 10.1097/01.IOP.0000103006.49679.23.

  PMID: 14752311 BACKGROUND

• Tucker SM, Linberg JV, Nguyen LL, Viti AJ, Tucker WJ. Measurement of the resistance to fluid flow within the lacrimal outflow system. Ophthalmology. 1995 Nov;102(11):1639-45. doi: 10.1016/s0161-6420(95)30815-9.

  PMID: 9098256 BACKGROUND

MeSH Terms

Conditions

Lacrimal Apparatus Diseases; Lacrimal Duct Obstruction; Ectropion

Condition Hierarchy (Ancestors)

Eye Diseases; Eyelid Diseases

Study Officials

• Julian D Perry, MD

  Cleveland Clinic Cole Eye Institute

  PRINCIPAL INVESTIGATOR

• Brian Costin, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 13, 2011
• First Posted: January 11, 2013
• Study Start: April 1, 2009
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 19, 2015

Record last verified: 2015-02

Locations

US (1)