NCT07225244

Comparative Outcomes of Four Versus Two Balloon Inflation Points in Dacryoplasty for Primary Acquired Nasolacrimal Duct Obstruction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Primary acquired nasolacrimal duct obstruction

Conditions

• Primary Acquired Nasolacrimal Duct Obstruction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2025-11-06
• Last updated: 2025-11-06

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated device study