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

November 5, 2025 updated by: National Taiwan University Hospital
Primary acquired nasolacrimal duct obstruction

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Yi-Hsuan Wei, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: From enrollment to 6 months after intervention

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
Time Frame: For enrollment to 6 months after intervention
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
Time Frame: For enrollment to 6 months after intervention
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

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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