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

Glaukos Corporation164 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

164

Conditions

Glaucoma

Interventions

iStent Inject (GTS400)DEVICE

Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery with subsequent implantation of GTS400 stents.

Cataract SurgeryPROCEDURE

Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with open-angle glaucoma in the study eye * Subject must be on 1 to 3 glaucoma medications * Subject able and willing to attend follow up visits for two years postop * Subject able and willing to sign informed consent Exclusion Criteria: * Pseudoexfoliative and pigmentary glaucoma * Prior glaucoma surgery of any type

Locations (22)

Boozman-Hof Regional Eye Clinic

Rogers, Arkansas, United States

Outcomes

Primary Outcomes

Proportion of subjects with 12 month diurnalIOP </= 21 mmHg without use of ocular hypotensive medications for >/= 4 weeks prior to 12 month visit.

Time frame: 12 months

Data from ClinicalTrials.gov

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