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

Primary acquired nasolacrimal duct obstruction

Study Overview

• Status: Recruiting
• Conditions: Primary Acquired Nasolacrimal Duct Obstruction
• Intervention / Treatment: Device: 4 point balloon dacryoplasty with LacriCATH®; Device: 2 point balloon dacryoplasty with LacriCATH®

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi-Hsuan Wei, PhD; Phone Number: +886-972653324; Email: wn0069@yahoo.com.tw
• Study Contact Backup: Name: Meng-Ju Lin, MD; Phone Number: +886-956238768; Email: linmengju8806@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Yi-Hsuan Wei, PhD; Phone Number: +886-972653324; Email: wn0069@yahoo.com.tw
    • Principal Investigator: Yi-Hsuan Wei, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4-point group; Balloon dacryoplasty with LacriCATH® at 4 different points in the nasolacrimal duct	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.
Active Comparator: 2-point group; Balloon dacryoplasty with LacriCATH® at 2 different points in the nasolacrimal duct	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear meniscus height	Tear meniscus height (TMH) will be objectively measured using the OCULUS Keratograph 5M, a noninvasive ocular surface analyzer. The measurement will be recorded in millimeters (mm) at each visit to assess tear volume and lacrimal drainage function.	For enrollment to 6 months after intervention
Patency of the nasolacrimal system assessed by probing and irrigation of the nasolacrimal duct	Patency of the nasolacrimal drainage system will be evaluated by performing probing and irrigation of the nasolacrimal duct under topical anesthesia. The outcome will be categorized as patent, partially obstructed, or completely obstructed based on the ease of probe passage and saline flow into the nasal cavity.	For enrollment to 6 months after intervention

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yi-Hsuan Wei, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: November 3, 2025
• First Submitted That Met QC Criteria: November 5, 2025
• First Posted (Estimated): November 6, 2025

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: November 5, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: balloon dacryoplasty
• Other Study ID Numbers: 202509023RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes