Follow up of Nasolacrimal Intubation in Adults - Full Text View

Purpose

For patients with chronic epiphora, Dacryocystorhinostomy is currently the gold standard treatment, with a success rate of 80-90% according to literature. Another available treatment, which is far less used, in nasolacrimal intubation, using a silicone tube.

In our study, we would like to find the efficacy of nasolacrimal duct intubation, which was performed in our medical center on a few hundred patients with mild epiphora.

Study hypothesis: nasolacrimal intubation in adults, with a clinically mild epiphora, is close in it's efficacy to the Dacryocystorhinostomy procedure.

Condition	Intervention
Lacrimal Apparatus Diseases Dacryocystitis	Device: Silicone tube

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective

Official Title:	Long Term Follow up of Nasolacrimal Intubation in Adults With Mild Epiphora

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:

Patient being completely free of tearing. [ Time Frame: 1 year. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Following nasolacrimal intubation, did the patient need a Dacryocystorhinostomy surgery. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	180
Study Start Date:	January 2000
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Primary All the patients in our medical center who underwent nasolacrimal intubation, due to mild epiphora, during the years 2000-2007.	Device: Silicone tube Silicone tube which is inserted into the tear duct through the punctum in the eyelid, then passed through the tear duct till it enters the nose and secured in place using a surgical knot. The tube remains in place for 3-6 months, than take out by the surgeon.

Detailed Description:

Under normal conditions, the amount of tears excreted from lacrimal glands to the eye is equal to the amount drained through the tear duct. Epiphora in adults usually involves a blockage of the lacrimal sac or the nasolacrimal duct. Epiphora causes tearing in patients, which can be treated sympthomatically in a conservative way (antibiotic treatment, probing of the tear duct, pressure irrigation of the tear duct) or therapeutic in an invasive way. The invasive treatment includes one of the following:

Dacryocystorhinostomy - surgery for reconstructing an alternative path for tear drainage.
Nasolacrimal intubation - inserting a silicone tube through the tear duct. The tube is usually removed after 3-6 months.

Currently, there are only a few reports regarding the efficacy of nasolacrimal intubation, all with a small number of research subjects. Also, these reports have stratified the patients according to the location of the tear duct blockage, and didn't take into account the severity of the blockage (ie the severity of symptoms) prior to performing the intubation.

In our research, we would like to find the efficacy of nasolacrimal intubation which was performed in our medical center on a few hundred patients with mild epiphora, and to compare in with the efficacy of the Dacryocystorhinostomy - which is 80-90% according to literature.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patient who underwent nasolacrimal intubation in Maccabi Healthcare, due to mild epiphora, during the years 2000-2007.

Criteria

Inclusion Criteria:

Clinical diagnosis of mild epiphora.
Underwent nasolacrimal intubation during 01/2000 - 12/2007.

Exclusion Criteria:

Purulent excretions from nasolacrimal duct on day of admission or intubation.
Nasolacrimal intubation in the past.
Dacryocystorhinostomy in the past.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706251

Locations


Israel
	Maccabi Healthcare Eye Clinic
	Tel Aviv, Israel

Sponsors and Collaborators

Shaare Zedek Medical Center

Investigators


Study Director:	Arie Nemet, MD	Shaare Zedek Medical Center, Maccabi Healthcare

Study Chair:	Arie Nemet, MD	Shaare Zedek Medical Center, Maccabi Healthcare

Principal Investigator:	Arie Nemet, MD	Shaare Zedek Medical Center, Maccabi Healthcare

More Information

Publications:

Becker BB, Berry FD, Koller H. Balloon catheter dilatation for treatment of congenital nasolacrimal duct obstruction. Am J Ophthalmol. 1996 Mar;121(3):304-9.

Hurwitz JJ, Rutherford S. Computerized survey of lacrimal surgery patients. Ophthalmology. 1986 Jan;93(1):14-9.

Keith CG. Intubation of the lacrimal passages. Am J Ophthalmol. 1968 Jan;65(1):70-4. No abstract available.

Quickert MH, Dryden RM. Probes for intubation in lacrimal drainage. Trans Am Acad Ophthalmol Otolaryngol. 1970 Mar-Apr;74(2):431-3. No abstract available.

Crawford JS. Intubation of obstructions in the lacrimal system. Can J Ophthalmol. 1977 Oct;12(4):289-92.

Pashby RC, Rathbun JE. Silicone tube intubation of the lacrimal drainage system. Arch Ophthalmol. 1979 Jul;97(7):1318-22.

Connell PP, Fulcher TP, Chacko E, O' Connor MJ, Moriarty P. Long term follow up of nasolacrimal intubation in adults. Br J Ophthalmol. 2006 Apr;90(4):435-6.

Responsible Party:	Shaare Zedek Medical center, Maccabi Healthcare Services ( Arie Nemet, MD )
Study ID Numbers:	LTFNIAME
First Received:	June 26, 2008
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00706251
Health Authority:	Israel: Ethics Commission

Study placed in the following topic categories:

Dacryocystitis

Eye Diseases

Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on August 21, 2008

Sponsored by:	Shaare Zedek Medical Center
Information provided by:	Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:	NCT00706251