NCT01052558

GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma

A Prospective, Randomized, Controlled, Parallel Groupos, Multicenter Clinical Investigation of the Glaukos Trabecular Micro-bypass Stent Model GTS400 in Conjunction With Cataract Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of the GTS400 trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.

Detailed description

Glaucoma is a collection of disorders characterized by progressive loss of visual field due to optic nerve damage. It is a leading cause of blindness in the United States, affecting 1-2% of individuals aged 60 and over. Management of glaucoma requires chronic, life-long treatment with a spectrum of therapeutic options including medications, laser treatment and surgical implants. The common goal among the various therapies is to lower intraocular pressure to target levels in order to prevent loss of visual fields from excessive pressure on the optic nerve.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DEVICE	iStent Inject (GTS400)	Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery with subsequent implantation of GTS400 stents.
PROCEDURE	Cataract Surgery	Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only.

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-01-20
• Last updated: 2015-05-19

Locations

22 sites across 1 country: United States