Primary Acquired Nasolacrimal Duct Obstruction
Conditions
Keywords
balloon dacryoplasty
Brief summary
Primary acquired nasolacrimal duct obstruction
Interventions
DEVICE2 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.
DEVICE4 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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Munk's scale for epiphora grading | 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
| Measure | Time frame | Description |
|---|---|---|
| Tear meniscus height | 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. |
| Patency of the nasolacrimal system assessed by probing and irrigation of the nasolacrimal duct | 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. |
Countries
Taiwan
Contacts
Primary ContactYi-Hsuan Wei, PhD
Backup ContactMeng-Ju Lin, MD
Outcome results
None listed