Functional Epiphora Management Via Different Dacryocystorhinostomy (DCR) Techniques

Not Applicable

Completed

• Conditions: Functional Epiphora (Tearing Without Any Anatomical Block)
• Interventions: Procedure: Transcanalicular Dacryocystorhinostomy; Procedure: External Dacryocystorhinostomy; Procedure: Endonasal Dacryocystorhinostomy

• Registration Number: NCT04952454
• Lead Sponsor: Istanbul University

Brief Summary

135 eyes of 135 patients treated between 2005 and 2017 will be included in this study. The diagnosis of functional epiphora was made based on a patent lacrimal system with a delay in the fluorescein dye disappearance test (FDDT) or dacryoscintigraphy (DSG) without any ocular surface or eyelid abnormalities. The absence of epiphora and normalization of FDDT postoperatively was defined as success. The study's hypothesis is that external DCR with a suitable technique will have better results compared to endonasal and transcanalicular DCR

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-06
• Last Update Submitted: 2021-07-06
• Study First Posted: 2021-07-07
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 135

Inclusion Criteria

• patent lacrimal irrigation and delay in the lacrimal transit time demonstrated by fluorescein dye disappearance test (FDDT) or a dacryoscintigraphy (DSG)

Exclusion Criteria

• Dry eye (tear break up time less than 10 seconds), ocular surface disorders, eyelid malposition or laxity, orbicularis weakness, partial block or stenosis of the lacrimal drainage, history of previous nasal, lacrimal, or ophthalmic surgeries, and a postoperative follow-up time less than six months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Transcanalicular DCR	Transcanalicular Dacryocystorhinostomy	Patients treated with Transcanalicular DCR for functional epiphora
External DCR	External Dacryocystorhinostomy	Patients treated with External DCR for functional epiphora
Endonasal DCR	Endonasal Dacryocystorhinostomy	Patients treated with Endonasal DCR for functional epiphora

Primary Outcome Measures

Name	Time	Method
Percentage of patients who report resolution of theri tearing and normalization of fluorescein dye disappearance test.	Last follow-up time, approximately 6 months

Secondary Outcome Measures

Name	Time	Method
Number of patients who have continuing epiphora after the surgery with an anatomically blocked tear duct.	Last follow-up time, approximately 6 months

Trial Locations

Locations (2)

Beyoglu Eye Research Hospital; 🇹🇷 Istanbul, Turkey

McMaster University; 🇨🇦 Hamilton, Ontario, Canada