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

NCT07225244 | Recruiting DMC FDA Device

• 1 other identifier: 202509023RIND
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Primary acquired nasolacrimal duct obstruction

Conditions

Primary Acquired Nasolacrimal Duct Obstruction

Keywords

balloon dacryoplasty

Outcome Measures

Primary Outcomes (1)

• Munk's scale for epiphora grading

  The frequency of epiphora will be evaluated at each follow-up visit using the Munk's scale, in which patients rate the frequency of tearing on a standardized 0-5 scale based on daily symptoms (as below). Grade 0: no epiphora Grade 1: epiphora requiring dabbing less than twice a day Grade 2: epiphora requiring dabbing 2-4 times a day Grade 3: epiphora requiring dabbing 5-10 times a day Grade 4: epiphora requiring dabbing more than 10 times a day Grade 5: constant epiphora The higher the grade, the worse the condition.

  From enrollment to 6 months after intervention

Secondary Outcomes (2)

• Tear meniscus height

  For enrollment to 6 months after intervention

• Patency of the nasolacrimal system assessed by probing and irrigation of the nasolacrimal duct

  For enrollment to 6 months after intervention

Study Arms (2)

4-point group

EXPERIMENTAL

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

Device: 4 point balloon dacryoplasty with LacriCATH®

2-point group

ACTIVE COMPARATOR

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

Device: 2 point balloon dacryoplasty with LacriCATH®

Interventions

2 point balloon dacryoplasty with LacriCATH® 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.

2-point group

4 point balloon dacryoplasty with LacriCATH® 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.

4-point group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Study Officials

• Yi-Hsuan Wei, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Hsuan Wei, PhD

CONTACT

+886-972653324; wn0069@yahoo.com.tw

Meng-Ju Lin, MD

CONTACT

+886-956238768; linmengju8806@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 6, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)