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A Comparison of Endonasal Dacryocystorhinostomy With and Without Silicone Tubes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00784992
First received: November 4, 2008
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Nasolacrimal Duct Obstruction
Procedure: Endonasal dacryocystorhinostomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial to Compare Success and Complication Rates in Endonasal Dacryocystorhinostomy Surgery With and Without Silicone Tubes

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The primary end point will be functional success, determined by patient-reported symptoms. This will be assessed a minimum of six months post-operatively. In patients with tubes these will be removed at 3 months post-operatively. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary end point will be anatomical success, as measured by patency of nasolacrimal irrigation at 6 months post-operatively. In patients with tubes these will be removed at 3 months post-operatively. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2008
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Endonasal DCR with silicone tubes (this is the control group since it is the standard procedure / gold standard, although the evidence base for the use of tubes is lacking, hence the need for this trial)
Active Comparator: 2
Endonasal DCR without silicone tubes (this is the 'intervention' arm)
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients (> 16 years) undergoing primary DCR for NLDO who have given fully informed consent to be in the trial

Exclusion Criteria:

  • Age less than 16 years
  • Previous ipsilateral DCR or nasal surgery
  • Canalicular disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784992

Contacts
Contact: Tessa Fayers, BSc MBChB 604-345-0343 peterdolman@hotmail.com

Locations
Canada, British Columbia
Eye Care Centre (Clinic) Recruiting
Vancouver, British Columbia, Canada
Contact: Tessa Fayers, BSc MBChB    604-345-0343    peterdolman@hotmail.com   
Principal Investigator: Peter Dolman, MD         
VGH/UBC (Operating Rooms) Recruiting
Vancouver, British Columbia, Canada
Contact: Tessa Fayers, BSc MBChB    604-345-0343    peterdolman@hotmail.com   
Principal Investigator: Peter Dolman, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Peter Dolman, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Peter Dolman MD, University of British Columbia
ClinicalTrials.gov Identifier: NCT00784992     History of Changes
Other Study ID Numbers: H08-02025
Study First Received: November 4, 2008
Last Updated: October 1, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
NLDO
DCR
silicone tubes
stent

ClinicalTrials.gov processed this record on November 25, 2014