Functional Epiphora Management Via Different Dacryocystorhinostomy (DCR) Techniques

NCT04952454 | Completed

• 1 other identifier: 1533-2020
• Study Type: interventional
• Target: 135
• Locations: 2 countries
• Sites: 2

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

Conditions

Functional Epiphora (Tearing Without Any Anatomical Block)

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who report resolution of theri tearing and normalization of fluorescein dye disappearance test.

  Last follow-up time, approximately 6 months

Secondary Outcomes (1)

• Number of patients who have continuing epiphora after the surgery with an anatomically blocked tear duct.

  Last follow-up time, approximately 6 months

Study Arms (3)

External DCR

ACTIVE COMPARATOR

Patients treated with External DCR for functional epiphora

Procedure: External Dacryocystorhinostomy

Endonasal DCR

ACTIVE COMPARATOR

Patients treated with Endonasal DCR for functional epiphora

Procedure: Endonasal Dacryocystorhinostomy

Transcanalicular DCR

ACTIVE COMPARATOR

Patients treated with Transcanalicular DCR for functional epiphora

Procedure: Transcanalicular Dacryocystorhinostomy

Interventions

External Dacryocystorhinostomy PROCEDURE

The resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via skin incision.

External DCR

Endonasal Dacryocystorhinostomy PROCEDURE

The resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via endonasal route.

Endonasal DCR

Transcanalicular Dacryocystorhinostomy PROCEDURE

The resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via transcanalicular route.

Transcanalicular DCR

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (2)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Beyoglu Eye Research Hospital

Istanbul, 34421, Turkey (Türkiye)

Location

Study Officials

• Can Ozturker, MD

  Istanbul University, Istanbul Facukty Of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asist. Prof.

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 7, 2021
• Study Start: May 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1); CA (1)