Recruiting NCT07225244
Comparative Outcomes of Four Versus Two Balloon Inflation Points in Dacryoplasty for Primary Acquired Nasolacrimal Duct Obstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 2 point balloon dacryoplasty with LacriCATH®, 4 point balloon dacryoplasty with LacriCATH®.
- Who it may be relevant to
- Registry conditions: Primary Acquired Nasolacrimal Duct Obstruction. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Munk's scale for epiphora grading [Time frame: From enrollment to 6 months after intervention]
Secondary outcome measures (2)
- Tear meniscus height [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT07225244 · 202509023RIND