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OpenTrials
Completed

NCT Number: NCT04952454

Functional Epiphora Management Via Different Dacryocystorhinostomy (DCR) Techniques

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

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Key information

Conditions

Functional Epiphora (Tearing Without Any Anatomical Block)

Age range

21 year and older

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

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

    Time frame: 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.

    Time frame: Last follow-up time, approximately 6 months

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2021
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.