Primary Acquired Nasolacrimal Duct ObstructionNCT07225244
Comparative Outcomes of Four Versus Two Balloon Inflation Points in Dacryoplasty for Primary Acquired Nasolacrimal Duct Obstruction
A study testing 2 point balloon dacryoplasty with LacriCATH® and 4 point balloon dacryoplasty with LacriCATH® in people with Primary Acquired Nasolacrimal Duct Obstruction, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Primary acquired nasolacrimal duct obstruction Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Primary Acquired Nasolacrimal Duct Obstruction
- What is being tested?
- 2 point balloon dacryoplasty with LacriCATH® and 4 point balloon dacryoplasty with LacriCATH®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with primary acquired nasolacrimal duct obstruction (PANDO)
Who cannot join
- Patients who are pregnant, with previous lacrimal procedure, upper lacrimal drainage obstruction, punctal stenosis, active dacryocystitis, dacryolithiasis, traumatic obstruction or lacrimal mass
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yi-Hsuan Wei, PhD, +886-972653324, wn0069@yahoo.com.tw
Yi-Hsuan Wei, PhD
About this study
Primary acquired nasolacrimal duct obstruction
- Being tested
- 2 point balloon dacryoplasty with LacriCATH®, 4 point balloon dacryoplasty with LacriCATH®
- Keywords
- balloon dacryoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 4-point group | Experimental | Balloon dacryoplasty with LacriCATH® at 4 different points in the nasolacrimal duct Receives: Device: 4 point balloon dacryoplasty with LacriCATH® |
| 2-point group | Active comparator | Balloon dacryoplasty with LacriCATH® at 2 different points in the nasolacrimal duct Receives: Device: 2 point balloon dacryoplasty with LacriCATH® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 6 months after intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: For enrollment to 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Acquired Nasolacrimal Duct ObstructionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Hsuan Wei, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225244
- Sponsor's protocol ID
- 202509023RIND
- Status last verified
- Oct 2025
- First submitted
- 3 Nov 2025
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Outcomes of Four Versus Two Balloon Inflation Points in Dacryoplasty for Primary Acquired Nasolacrimal Duct Obstruction
- ClinicalTrials.gov ID
- NCT07225244
- Acronym / sponsor ID
- 202509023RIND
- Keywords
- balloon dacryoplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 6 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary acquired nasolacrimal duct obstruction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-point group | Experimental | Device: 4 point balloon dacryoplasty with LacriCATH®Balloon dacryoplasty with LacriCATH® at 4 different points in the nasolacrimal duct |
| 2-point group | Active comparator | Device: 2 point balloon dacryoplasty with LacriCATH®Balloon dacryoplasty with LacriCATH® at 2 different points in the nasolacrimal duct |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with primary acquired nasolacrimal duct obstruction (PANDO)
Key exclusion criteria (1 listed)
- Patients who are pregnant, with previous lacrimal procedure, upper lacrimal drainage obstruction, punctal stenosis, active dacryocystitis, dacryolithiasis, traumatic obstruction or lacrimal mass
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 2-point group |
| 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. | Device | 4-point group |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: No
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Recruiting
Efficacy Evaluation of 5-Fluorouracil as an Adjuvant to Endoscopic Dacryocystorhinostomy in Managing Primary Acquired Nasolacrimal Duct Obstruction With Small Lacrimal Sac: A Randomized Controlled Study
Primary Acquired Nasolacrimal Duct Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi-Hsuan Wei, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 point balloon dacryoplasty with LacriCATH® and 4 point balloon dacryoplasty with LacriCATH® in people with Primary Acquired Nasolacrimal Duct Obstruction, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Hsuan Wei, PhD (+886-972653324, wn0069@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Munk's scale for epiphora grading (time frame: From enrollment to 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.