National Taiwan University Hospital
Taipei, Taiwan
Location status: Recruiting
Recruiting
NCT Number: NCT07225244
Comparative Outcomes of Four Versus Two Balloon Inflation Points in Dacryoplasty for Primary Acquired Nasolacrimal Duct Obstruction
Primary acquired nasolacrimal duct obstruction
Recruiting
Interested in participating?
Request InfoKey information
Age range
20 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
2 point balloon dacryoplasty with LacriCATH®
DeviceBalloon 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.
4 point balloon dacryoplasty with LacriCATH®
DeviceBalloon 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.
Primary outcomes
-
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.
Secondary outcomes
-
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.
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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.
Study contacts
Contact information is provided by the study sponsor or research team.
Meng-Ju Lin, MD
CONTACT
Yi-Hsuan Wei, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
National Taiwan University Hospital
Other
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Nov 6, 2025
- Registry last updated
- Nov 6, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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