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Completed

NCT Number: NCT01052558

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

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.

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Key information

Conditions

Glaucoma Cataract Eye Diseases Lens Diseases Ocular Hypertension

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Boozman-Hof Regional Eye Clinic, Rogers, Arkansas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Cataract surgery, stent implantation

cataract surgery

Procedure

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 20, 2010
Registry last updated
May 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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