Follow up of Nasolacrimal Intubation in Adults

Sponsor
Shaare Zedek Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00706251
Collaborator
(none)
180
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Silicone tube

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 Design

Study Type:
Observational
Actual Enrollment :
180 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Long Term Follow up of Nasolacrimal Intubation in Adults With Mild Epiphora
Study Start Date :
Jan 1, 2000
Actual Primary Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Patient being completely free of tearing. [1 year.]

Secondary Outcome Measures

  1. Following nasolacrimal intubation, did the patient need a Dacryocystorhinostomy surgery. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00706251
Other Study ID Numbers:
  • LTFNIAME
First Posted:
Jun 27, 2008
Last Update Posted:
Jun 27, 2008
Last Verified:
Jun 1, 2008
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2008