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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | June 26, 2008 | ||||||||||||
| Last Updated Date | June 26, 2008 | ||||||||||||
| Start Date ICMJE | January 2000 | ||||||||||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Patient being completely free of tearing. [ Time Frame: 1 year. ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | No Changes Posted | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
Following nasolacrimal intubation, did the patient need a Dacryocystorhinostomy surgery. [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Follow up of Nasolacrimal Intubation in Adults | ||||||||||||
| Official Title ICMJE | Long Term Follow up of Nasolacrimal Intubation in Adults With Mild Epiphora | ||||||||||||
| 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. |
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| 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:
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. |
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| Study Phase | |||||||||||||
| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Cohort, Retrospective | ||||||||||||
| Condition ICMJE |
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| Intervention ICMJE | Device: Silicone tube | ||||||||||||
| Study Arms / Comparison Groups | All the patients in our medical center who underwent nasolacrimal intubation, due to mild epiphora, during the years 2000-2007. | ||||||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 180 | ||||||||||||
| Completion Date | |||||||||||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years to 75 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Israel | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00706251 | ||||||||||||
| Responsible Party | Arie Nemet, MD, Shaare Zedek Medical center, Maccabi Healthcare Services | ||||||||||||
| Study ID Numbers ICMJE | LTFNIAME | ||||||||||||
| Study Sponsor ICMJE | Shaare Zedek Medical Center | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
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| Information Provided By | Shaare Zedek Medical Center | ||||||||||||
| Verification Date | June 2008 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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