A Comparison of Endonasal Dacryocystorhinostomy With and Without Silicone Tubes

NCT00784992 | Completed Phase 4

• 1 other identifier: H08-02025
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

NLDO; DCR; silicone tubes; stent

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• 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.

  6 months

Study Arms (2)

1

NO INTERVENTION

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)

2

ACTIVE COMPARATOR

Endonasal DCR without silicone tubes (this is the 'intervention' arm)

Procedure: Endonasal dacryocystorhinostomy

Interventions

Endonasal dacryocystorhinostomy PROCEDURE

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.

2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Age less than 16 years
• Previous ipsilateral DCR or nasal surgery
• Canalicular disease

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (2)

Eye Care Centre (Clinic)

Vancouver, British Columbia, Canada

Location

VGH/UBC (Operating Rooms)

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Lacrimal Duct Obstruction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Peter Dolman, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: November 1, 2008
• Primary Completion: June 2, 2016
• Study Completion: June 2, 2016
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

CA (2)