Follow up of Nasolacrimal Intubation in Adults

Dacryocystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706251
• Other study ID #: LTFNIAME
• Status: Completed
• Phase: N/A
• First received: June 26, 2008
• Last updated: June 26, 2008
• Start date: January 2000

Study information

• Verified date: June 2008
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Dacryocystitis
• Lacrimal Apparatus Diseases

Intervention

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.

Locations

Country	Name	City	State
Israel	Maccabi Healthcare Eye Clinic	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (7)

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. — View Citation

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. — View Citation

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

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

Keith CG. Intubation of the lacrimal passages. Am J Ophthalmol. 1968 Jan;65(1):70-4. — View Citation

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

Quickert MH, Dryden RM. Probes for intubation in lacrimal drainage. Trans Am Acad Ophthalmol Otolaryngol. 1970 Mar-Apr;74(2):431-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient being completely free of tearing.		1 year.	No
Secondary	Following nasolacrimal intubation, did the patient need a Dacryocystorhinostomy surgery.		1 year	No