Functional Epiphora Management Via Different Dacryocystorhinostomy (DCR) Techniques

NCT ID: NCT04952454

Last Updated: 2021-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2021-06-01

Brief Summary

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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

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Conditions

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Functional Epiphora (Tearing Without Any Anatomical Block)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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External DCR

Patients treated with External DCR for functional epiphora

Group Type ACTIVE_COMPARATOR

External Dacryocystorhinostomy

Intervention Type 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 DCR

Patients treated with Endonasal DCR for functional epiphora

Group Type ACTIVE_COMPARATOR

Endonasal Dacryocystorhinostomy

Intervention Type 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 DCR

Patients treated with Transcanalicular DCR for functional epiphora

Group Type ACTIVE_COMPARATOR

Transcanalicular Dacryocystorhinostomy

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Can Ozturker

Asist. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Can Ozturker, MD

Role: STUDY_DIRECTOR

Istanbul University, Istanbul Facukty Of Medicine

Locations

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McMaster University

Hamilton, Ontario, Canada

Site Status

Beyoglu Eye Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Canada Turkey (Türkiye)

Other Identifiers

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1533-2020

Identifier Type: -

Identifier Source: org_study_id

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