NCT00706251

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2008

Completed
Last Updated

June 27, 2008

Status Verified

June 1, 2008

Enrollment Period

7.9 years

First QC Date

June 26, 2008

Last Update Submit

June 26, 2008

Conditions

Lacrimal Apparatus DiseasesDacryocystitis

Outcome Measures

Primary Outcomes (1)

  • Patient being completely free of tearing.

    1 year.

Secondary Outcomes (1)

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

    1 year

Study Arms (1)

Primary

All the patients in our medical center who underwent nasolacrimal intubation, due to mild epiphora, during the years 2000-2007.

Device: Silicone tube

Interventions

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.

Primary

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient who underwent nasolacrimal intubation in Maccabi Healthcare, due to mild epiphora, during the years 2000-2007.

You may qualify if:

  • Clinical diagnosis of mild epiphora.
  • Underwent nasolacrimal intubation during 01/2000 - 12/2007.

You may not qualify if:

  • Purulent excretions from nasolacrimal duct on day of admission or intubation.
  • Nasolacrimal intubation in the past.
  • Dacryocystorhinostomy in the past.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maccabi Healthcare Eye Clinic

Tel Aviv, Israel

Location

Related Publications (7)

  • 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.

    PMID: 8597274BACKGROUND

  • Hurwitz JJ, Rutherford S. Computerized survey of lacrimal surgery patients. Ophthalmology. 1986 Jan;93(1):14-9. doi: 10.1016/s0161-6420(86)33779-5.

    PMID: 3951812BACKGROUND

  • Keith 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.

    PMID: 5635571BACKGROUND

  • Quickert MH, Dryden RM. Probes for intubation in lacrimal drainage. Trans Am Acad Ophthalmol Otolaryngol. 1970 Mar-Apr;74(2):431-3. No abstract available.

    PMID: 5445947BACKGROUND

  • Crawford JS. Intubation of obstructions in the lacrimal system. Can J Ophthalmol. 1977 Oct;12(4):289-92.

    PMID: 922571BACKGROUND

  • Pashby 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.

    PMID: 454271BACKGROUND

  • Connell 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.

    PMID: 16547322BACKGROUND

MeSH Terms

Conditions

Lacrimal Apparatus DiseasesDacryocystitis

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Arie Nemet, MD

    Shaare Zedek Medical Center, Maccabi Healthcare

    STUDY DIRECTOR

  • Arie Nemet, MD

    Shaare Zedek Medical Center, Maccabi Healthcare

    STUDY CHAIR

  • Arie Nemet, MD

    Shaare Zedek Medical Center, Maccabi Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 26, 2008

First Posted

June 27, 2008

Study Start

January 1, 2000

Primary Completion

December 1, 2007

Last Updated

June 27, 2008

Record last verified: 2008-06

Locations

IL(1)