NCT02226094

Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension

A Prospective, Randomized, Controlled Clinical Feasibility Investigation of the Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT) Subjects

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: OcuTherix, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to investigate the safety and efficacy of bilateral DWT in subjects with POAG or OHT compared to active and sham controls. The secondary purpose of the study is to investigate the durability, repeatability, and does response of the same.

Conditions

• Primary Open-angle Glaucoma (POAG)
• Ocular Hypertension (OHT)

Interventions

Type	Name	Description
DEVICE	DWT device dose A	Deep Wave Trabeculoplasty (DWT) is an investigational device intended to reduce IOP in patients with POAG or OHT. The DWT device applies focal mechanical oscillation (low amplitude, sonic frequency) to the surface of the eye proximate the limbal region and anterior to the trabecular meshwork (TM). Mechanical oscillation of the TM by the DWT device is believed to initiate a physiological cascade to restore function of the TM, increase the outflow of aqueous humor and thereby decrease the IOP. DWT involves 24 spot treatments applied around the limbal region on the ocular surface. Dose A refers to 10 second spot treatments.
DEVICE	Ellex Tango SLT machine	Laser trabeculoplasty is the application of a laser beam to burn areas of the trabecular meshwork, located near the base of the iris, to increase fluid outflow. Selective laser trabeculoplasty (SLT) uses a Nd:YAG laser to target specific cells within the trabecular meshwork and create thermal damage.
DEVICE	DWT device dose B	Same as DWT device dose A except 20 second spot treatments.
DEVICE	DWT sham	Same as DWT device dose A except device not applied to ocular surface.

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-06-01
• Completion: 2015-12-01
• First posted: 2014-08-27
• Last updated: 2017-04-04

Locations

2 sites across 1 country: Philippines