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OpenTrials
Completed

NCT Number: NCT00706251

Follow up of Nasolacrimal Intubation in Adults

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.

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Key information

Conditions

Lacrimal Apparatus Diseases Dacryocystitis Eye Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maccabi Healthcare Eye Clinic

Tel Aviv, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Silicone tube

Device

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.

Primary outcomes

  1. Patient being completely free of tearing.

    Time frame: 1 year.

Secondary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2007
First posted
Jun 27, 2008
Registry last updated
Jun 27, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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