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A Comparison of Endonasal Dacryocystorhinostomy With and Without Silicone Tubes

NCT00784992 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-03-03

No results posted yet for this study

Summary

Aim of study is to investigate whether the use of silicone tubes in endonasal DCR surgery increases the success rate and / or complication rate compared to surgery without tubes.

Conditions

  • Nasolacrimal Duct Obstruction

Interventions

PROCEDURE

Endonasal dacryocystorhinostomy

The standard dacryocystorhinostomy operation performed in this centre uses silicone tubes to stent open the newly created ostium between the lacrimal sac and the nasal cavity. However many surgeons in other departments / countries around the world perform the surgery without tubes. No large well-conducted RCT has been published comparing success rates / complication rates for the two techniques. For this study the control group is the arm which receives tubes (our standard procedure) and the 'interventional' group is the arm not receiving tubes. Details of the operative technique for endonasal DCR with tubes can be found in the following reference: Dolman PJ. Comparison of external dacryocystorhinostomy with nonlaser endonasal dacryocystorhinostomy. Ophthalmology. 2003 Jan;110(1):78-84. The group that will not receive tubes will undergo the same procedure except that the insertion of tubes will be omitted.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Peter Dolman, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2016-06-02
Completion
2016-06-02

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00784992 on ClinicalTrials.gov