Functional Epiphora Management Via Different Dacryocystorhinostomy (DCR) Techniques

Non-endoscopic Endonasal, Transcanalicular, or External Dacryocystorhinostomy for Functional Epiphora: Which is Better?

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

Study Overview

• Status: Completed
• Conditions: Functional Epiphora (Tearing Without Any Anatomical Block)
• Intervention / Treatment: Procedure: External Dacryocystorhinostomy; Procedure: Endonasal Dacryocystorhinostomy; Procedure: Transcanalicular Dacryocystorhinostomy

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4L8
      • McMaster University
• Turkey
  • Istanbul, Turkey, 34421
    • Beyoglu Eye Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: External DCR; Patients treated with External DCR for functional epiphora	Procedure: External Dacryocystorhinostomy; The resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via skin incision.
Active Comparator: Endonasal DCR; Patients treated with Endonasal DCR for functional epiphora	Procedure: Endonasal Dacryocystorhinostomy; The resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via endonasal route.
Active Comparator: Transcanalicular DCR; Patients treated with Transcanalicular DCR for functional epiphora	Procedure: Transcanalicular Dacryocystorhinostomy; The resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via transcanalicular route.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Study Director: Can Ozturker, MD, Istanbul University, Istanbul Facukty Of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 6, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases
• Other Study ID Numbers: 1533-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No