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Follow up of Nasolacrimal Intubation in Adults
This study has been completed.
Study NCT00706251   Information provided by Shaare Zedek Medical Center
First Received: June 26, 2008   No Changes Posted

June 26, 2008
June 26, 2008
January 2000
December 2007   (final data collection date for primary outcome measure)
Patient being completely free of tearing. [ Time Frame: 1 year. ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Following nasolacrimal intubation, did the patient need a Dacryocystorhinostomy surgery. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
 
Follow up of Nasolacrimal Intubation in Adults
Long Term Follow up of Nasolacrimal Intubation in Adults With Mild Epiphora

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.

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.

 
Observational
Cohort, Retrospective
  • Lacrimal Apparatus Diseases
  • Dacryocystitis
Device: Silicone tube
All the patients in our medical center who underwent nasolacrimal intubation, due to mild epiphora, during the years 2000-2007.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
180
 
December 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00706251
Arie Nemet, MD, Shaare Zedek Medical center, Maccabi Healthcare Services
LTFNIAME
Shaare Zedek Medical Center
 
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
Shaare Zedek Medical Center
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP