Follow up of Nasolacrimal Intubation in Adults

Completed

• Conditions: Lacrimal Apparatus Diseases; Dacryocystitis
• Interventions: Device: Silicone tube

• Registration Number: NCT00706251
• Lead Sponsor: Shaare Zedek Medical Center

Brief Summary

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.

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:

1. Dacryocystorhinostomy - surgery for reconstructing an alternative path for tear drainage.

2. 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.

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2007-12
• Status Verified: 2008-06
• Study First Submitted: 2008-06-26
• Study First Submitted QC: 2008-06-26
• Last Update Submitted: 2008-06-26
• Study First Posted: 2008-06-27
• Last Update Posted: 2008-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary	Silicone tube	All the patients in our medical center who underwent nasolacrimal intubation, due to mild epiphora, during the years 2000-2007.

Primary Outcome Measures

Name	Time	Method
Patient being completely free of tearing.	1 year.

Secondary Outcome Measures

Name	Time	Method
Following nasolacrimal intubation, did the patient need a Dacryocystorhinostomy surgery.	1 year

Trial Locations

Locations (1)

Maccabi Healthcare Eye Clinic; 🇮🇱 Tel Aviv, Israel