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Comparative Outcomes of Four Versus Two Balloon Inflation Points in Dacryoplasty for Primary Acquired Nasolacrimal Duct Obstruction

NCT ID: NCT07225244

Last Updated: 2025-11-06

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

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2028-06-30

Brief Summary

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Primary acquired nasolacrimal duct obstruction

Detailed Description

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Conditions

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Primary Acquired Nasolacrimal Duct Obstruction

Keywords

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balloon dacryoplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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4-point group

Balloon dacryoplasty with LacriCATH® at 4 different points in the nasolacrimal duct

Group Type EXPERIMENTAL

4 point balloon dacryoplasty with LacriCATH®

Intervention Type DEVICE

Balloon dacryoplasty with LacriCATH® (QUEST Medical Inc., Allen, TX, USA, 3 mm balloon diameter, 15 mm in length). The balloon will be inflated to 8 bars of pressure for 90 seconds and deflated at four different points.

2-point group

Balloon dacryoplasty with LacriCATH® at 2 different points in the nasolacrimal duct

Group Type ACTIVE_COMPARATOR

2 point balloon dacryoplasty with LacriCATH®

Intervention Type DEVICE

Balloon dacryoplasty with LacriCATH® (QUEST Medical Inc., Allen, TX, USA, 3 mm balloon diameter, 15 mm in length). The balloon will be inflated to 8 bars of pressure for 90 seconds, deflated, and re-inflated to 8 bars of pressure for an additional 90 seconds at two different points.

Interventions

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2 point balloon dacryoplasty with LacriCATH®

Balloon dacryoplasty with LacriCATH® (QUEST Medical Inc., Allen, TX, USA, 3 mm balloon diameter, 15 mm in length). The balloon will be inflated to 8 bars of pressure for 90 seconds, deflated, and re-inflated to 8 bars of pressure for an additional 90 seconds at two different points.

Intervention Type DEVICE

4 point balloon dacryoplasty with LacriCATH®

Balloon dacryoplasty with LacriCATH® (QUEST Medical Inc., Allen, TX, USA, 3 mm balloon diameter, 15 mm in length). The balloon will be inflated to 8 bars of pressure for 90 seconds and deflated at four different points.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with primary acquired nasolacrimal duct obstruction (PANDO)

Exclusion Criteria

* Patients who are pregnant, with previous lacrimal procedure, upper lacrimal drainage obstruction, punctal stenosis, active dacryocystitis, dacryolithiasis, traumatic obstruction or lacrimal mass
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yi-Hsuan Wei, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yi-Hsuan Wei, PhD

Role: CONTACT

Phone: +886-972653324

Email: [email protected]

Meng-Ju Lin, MD

Role: CONTACT

Phone: +886-956238768

Email: [email protected]

Facility Contacts

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Yi-Hsuan Wei, PhD

Role: primary

Other Identifiers

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202509023RIND

Identifier Type: -

Identifier Source: org_study_id