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Functional Epiphora Management Via Different Dacryocystorhinostomy (DCR) Techniques

I

Istanbul University

Status

Completed

Conditions

Functional Epiphora (Tearing Without Any Anatomical Block)

Treatments

Procedure: External Dacryocystorhinostomy
Procedure: Transcanalicular Dacryocystorhinostomy
Procedure: Endonasal Dacryocystorhinostomy

Study type

Interventional

Funder types

Other

Identifiers

NCT04952454
1533-2020

Details and patient eligibility

About

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

Enrollment

135 patients

Sex

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

135 participants in 3 patient groups

External DCR
Active Comparator group
Description:
Patients treated with External DCR for functional epiphora
Treatment:
Procedure: External Dacryocystorhinostomy
Endonasal DCR
Active Comparator group
Description:
Patients treated with Endonasal DCR for functional epiphora
Treatment:
Procedure: Endonasal Dacryocystorhinostomy
Transcanalicular DCR
Active Comparator group
Description:
Patients treated with Transcanalicular DCR for functional epiphora
Treatment:
Procedure: Transcanalicular Dacryocystorhinostomy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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