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| Descriptive Information Fields | |||||||||||||
| Brief Title † | Follow up of Nasolacrimal Intubation in Adults | ||||||||||||
| Official Title † | 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 † | Observational | ||||||||||||
| Study Design † | Cohort, Retrospective | ||||||||||||
| Primary Outcome Measure † | Patient being completely free of tearing. [ Time Frame: 1 year. ] [ Designated as safety issue: No ] | ||||||||||||
| Secondary Outcome Measure † | Following nasolacrimal intubation, did the patient need a Dacryocystorhinostomy surgery. [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||||||
| Condition † | Lacrimal Apparatus Diseases Dacryocystitis |
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| Intervention † | Device: Silicone tube | ||||||||||||
| MEDLINE PMIDs | 8597274, 3951812, 5635571, 5445947, 922571, 454271, 16547322 | ||||||||||||
| Links | |||||||||||||
| Recruitment Information Fields | |||||||||||||
| Recruitment Status † | Completed | ||||||||||||
| Enrollment † | 180 | ||||||||||||
| Start Date † | January 2000 | ||||||||||||
| Completion Date | |||||||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years to 75 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts †† | |||||||||||||
| Location Countries † | Israel | ||||||||||||
| Administrative Information Fields | |||||||||||||
| NCT ID † | NCT00706251 | ||||||||||||
| Organization ID | LTFNIAME | ||||||||||||
| Secondary IDs †† | |||||||||||||
| Study Sponsor † | Shaare Zedek Medical Center | ||||||||||||
| Collaborators †† | |||||||||||||
| Investigators † |
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| Information Provided By | Shaare Zedek Medical Center | ||||||||||||
| Verification Date | June 2008 | ||||||||||||
| First Received Date † | June 26, 2008 | ||||||||||||
| Last Updated Date | June 26, 2008 | ||||||||||||
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