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Primary acquired nasolacrimal duct obstruction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4-point group | Experimental | Balloon dacryoplasty with LacriCATH® at 4 different points in the nasolacrimal duct |
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| 2-point group | Active Comparator | Balloon dacryoplasty with LacriCATH® at 2 different points in the nasolacrimal duct |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 6 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | For enrollment to 6 months after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi-Hsuan Wei, PhD | Contact | +886-972653324 | wn0069@yahoo.com.tw | |
| Meng-Ju Lin, MD | Contact | +886-956238768 | linmengju8806@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi-Hsuan Wei, PhD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
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| 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. |
|
| 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. |
| For enrollment to 6 months after intervention |