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

NCT07225244 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-11-06

No results posted yet for this study

Summary

Primary acquired nasolacrimal duct obstruction

Conditions

  • Primary Acquired Nasolacrimal Duct Obstruction

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Yi-Hsuan Wei, PhD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2027-12-31
Completion
2028-06-30
FDA Device
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07225244 on ClinicalTrials.gov