NCT01540331

Efficacy And Safety of Pneumatic Trabeculoplasty

Phase 4 Study to Evaluate Efficacy And Safety of Pneumatic Trabeculoplasty (PNT) in Subjects Affected by Primary Open Angle Glaucoma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Catanzaro · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate prospectively the PNT safety and efficacy in term of IOP reduction in a group of previously or newly diagnosed glaucomatous subjects.

Detailed description

A group of subjects affected by Primary Open Angle Glaucoma (POAG) underwent 3 PNT treatments to evaluate one-year efficacy in term of IOP reduction and one-year safety in term of incidence of adverse events

Conditions

• Primary Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	"model 1000 PNT vacuum controller" (the vacuum device for ocular suction)	A Pneumatic Trabeculoplasty treatment, composed of 3 single PNT applications at day 0, 7 and 90. Each treatment consist in a ocular pneumatic suction of 500inchHg administered for 60 seconds in perilimbal region through the device (model 1000 PNT vacuum controller). This suction is then repeated after a 5 minutes pause.

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-06-01
• Completion: 2012-01-01
• First posted: 2012-02-28
• Last updated: 2012-02-28

Locations

1 site across 1 country: Italy