Endoscopic Dacryocystorhinostomy Prospective Research

Lacrimal Duct Obstruction Clinical Trial

Official title:

Recovery After Endoscopic Dacryocystorhinostomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00571129
• Other study ID #: KUH5551812
• Secondary ID: 255104
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2004
• Est. completion date: December 2021

Study information

• Verified date: February 2020
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endoscopic dacryocystorhinostomy (EN-DCR) is an effective procedure when treating saccal and postsaccal obstructions of the nasolacrimal pathway. The benefit of silicone tubing after DCR is still controversial. We conducted a prospective, randomized study in order to evaluate 1) the necessity of bicanalicular silicone tubes after primary EN-DCR, 2) efficacy of the perioperative Mitomycin C for the prevention of adheesion and re-stenosis of rhinostomy site in revision EN-DCR, 3) the subjective symptoms and QoL changes before and after DCR-operation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2021
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Adults (age > 18), ASAI-III, and were scheduled for primary or revision lacrimal pathway surgery due to recurrent or chronic watering eyes or conjunctival discharge.

• Patients were excluded if they had previous nasolacrimal surgery, malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.

Exclusion Criteria:

• Malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.

Related Conditions & MeSH terms

• Lacrimal Duct Obstruction

Intervention

Procedure:
• DCR with no tubes or mitomycin
The patients were randomized into the two study groups, either with or without the insertion of a bicanalicular silicone tube after primary DCR. In revision group patients were randomized into the two groups,ether with or without application of mitomycin "C" after DCR

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio	North-Savo

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Penttilä E, Hyttinen JM, Hytti M, Kauppinen A, Smirnov G, Tuomilehto H, Seppä J, Nuutinen J, Kaarniranta K. Upregulation of inflammatory genes in the nasal mucosa of patients undergoing endonasal dacryocystorhinostomy. Clin Ophthalmol. 2014 Apr 25;8:799-805. doi: 10.2147/OPTH.S50195. eCollection 2014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate after primary DCR with and without silicone tubes. The success rate after revisio DCR with and without Mitomycin C.		5 years
Secondary	The EN-DCR operation influence on the patients subjective symptoms and QoL before and after operation.		5 years