Lacrimal Apparatus DiseasesNCT00706251
Follow up of Nasolacrimal Intubation in Adults
An observational study of Lacrimal Apparatus Diseases and Dacryocystitis, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lacrimal Apparatus Diseases, Dacryocystitis
- What is being tested?
- Silicone tube
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2000to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who underwent nasolacrimal intubation in Maccabi Healthcare, due to mild epiphora, during the years 2000-2007.
Who may be able to join
- Clinical diagnosis of mild epiphora.
- Underwent nasolacrimal intubation during 01/2000 - 12/2007.
Who cannot join
- Purulent excretions from nasolacrimal duct on day of admission or intubation.
- Nasolacrimal intubation in the past.
- Dacryocystorhinostomy in the past.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Lacrimal Apparatus Diseases, Dacryocystitis
- Being tested
- Silicone tube
- Medical subject headings
- Lacrimal Apparatus Diseases, Dacryocystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone tubeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary | All the patients in our medical center who underwent nasolacrimal intubation, due to mild epiphora, during the years 2000-2007. Receives: Device: Silicone tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient being completely free of tearing.
Measured: 1 year.
Secondary outcomes (1)
Following nasolacrimal intubation, did the patient need a Dacryocystorhinostomy surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startJan 2000
- Primary completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lacrimal Apparatus DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Arie Nemet, MD, Study director, Shaare Zedek Medical Center, Maccabi HealthcareArie Nemet, MD, Study chair, Shaare Zedek Medical Center, Maccabi HealthcareArie Nemet, MD, Principal investigator, Shaare Zedek Medical Center, Maccabi Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706251
- Sponsor's protocol ID
- LTFNIAME
- Status last verified
- Jun 2008
- First submitted
- 26 Jun 2008
- Last updated
- 27 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Becker BB, Berry FD, Koller H. Balloon catheter dilatation for treatment of congenital nasolacrimal duct obstruction. Am J Ophthalmol. 1996 Mar;121(3):304-9. doi: 10.1016/s0002-9394(14)70279-x.
PubMed 8597274Hurwitz JJ, Rutherford S. Computerized survey of lacrimal surgery patients. Ophthalmology. 1986 Jan;93(1):14-9. doi: 10.1016/s0161-6420(86)33779-5.
PubMed 3951812Keith CG. Intubation of the lacrimal passages. Am J Ophthalmol. 1968 Jan;65(1):70-4. doi: 10.1016/0002-9394(68)91031-3. No abstract available.
PubMed 5635571Quickert MH, Dryden RM. Probes for intubation in lacrimal drainage. Trans Am Acad Ophthalmol Otolaryngol. 1970 Mar-Apr;74(2):431-3. No abstract available.
PubMed 5445947Crawford JS. Intubation of obstructions in the lacrimal system. Can J Ophthalmol. 1977 Oct;12(4):289-92.
PubMed 922571Pashby RC, Rathbun JE. Silicone tube intubation of the lacrimal drainage system. Arch Ophthalmol. 1979 Jul;97(7):1318-22. doi: 10.1001/archopht.1979.01020020060014.
PubMed 454271Connell PP, Fulcher TP, Chacko E, O' Connor MJ, Moriarty P. Long term follow up of nasolacrimal intubation in adults. Br J Ophthalmol. 2006 Apr;90(4):435-6. doi: 10.1136/bjo.2005.084590.
PubMed 16547322
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow up of Nasolacrimal Intubation in Adults With Mild Epiphora
- ClinicalTrials.gov ID
- NCT00706251
- Acronym / sponsor ID
- LTFNIAME
- Conditions
- Lacrimal Apparatus Diseases, Dacryocystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2007 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary | – | Device: Silicone tubeAll the patients in our medical center who underwent nasolacrimal intubation, due to mild epiphora, during the years 2000-2007. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who underwent nasolacrimal intubation in Maccabi Healthcare, due to mild epiphora, during the years 2000-2007.
Key inclusion criteria (2 listed)
- Clinical diagnosis of mild epiphora.
- Underwent nasolacrimal intubation during 01/2000 - 12/2007.
Key exclusion criteria (3 listed)
- Purulent excretions from nasolacrimal duct on day of admission or intubation.
- Nasolacrimal intubation in the past.
- Dacryocystorhinostomy in the past.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silicone tubeSilicone 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. | Device | Primary |
Primary outcome
Patient being completely free of tearing.
Time frame: 1 year.
1 secondary outcome
Following nasolacrimal intubation, did the patient need a Dacryocystorhinostomy surgery.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2008.
- Background: PubMed 8597274Becker BB, Berry FD, Koller H. Balloon catheter dilatation for treatment of congenital nasolacrimal duct obstruction. Am J Ophthalmol. 1996 Mar;121(3):304-9. doi: 10.1016/s0002-9394(14)70279-x.
- Background: PubMed 3951812Hurwitz JJ, Rutherford S. Computerized survey of lacrimal surgery patients. Ophthalmology. 1986 Jan;93(1):14-9. doi: 10.1016/s0161-6420(86)33779-5.
- Background: PubMed 5635571Keith CG. Intubation of the lacrimal passages. Am J Ophthalmol. 1968 Jan;65(1):70-4. doi: 10.1016/0002-9394(68)91031-3. No abstract available.
- Background: PubMed 5445947Quickert MH, Dryden RM. Probes for intubation in lacrimal drainage. Trans Am Acad Ophthalmol Otolaryngol. 1970 Mar-Apr;74(2):431-3. No abstract available.
- Background: PubMed 922571Crawford JS. Intubation of obstructions in the lacrimal system. Can J Ophthalmol. 1977 Oct;12(4):289-92.
- Background: PubMed 454271Pashby RC, Rathbun JE. Silicone tube intubation of the lacrimal drainage system. Arch Ophthalmol. 1979 Jul;97(7):1318-22. doi: 10.1001/archopht.1979.01020020060014.
- Background: PubMed 16547322Connell PP, Fulcher TP, Chacko E, O' Connor MJ, Moriarty P. Long term follow up of nasolacrimal intubation in adults. Br J Ophthalmol. 2006 Apr;90(4):435-6. doi: 10.1136/bjo.2005.084590.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arie Nemet, MD study director
Shaare Zedek Medical Center, Maccabi Healthcare
Arie Nemet, MD study chair
Shaare Zedek Medical Center, Maccabi Healthcare
Arie Nemet, MD principal investigator
Shaare Zedek Medical Center, Maccabi Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lacrimal Apparatus Diseases and Dacryocystitis, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient being completely free of tearing. (time frame: 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00706251, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2008; AzTrials last refreshed its copy on 8 Nov 2026.