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

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Glaukos

Status and phase

Completed
Phase 3

Conditions

Glaucoma

Treatments

Procedure: Cataract Surgery
Device: iStent Inject (GTS400)

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

164 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

164 participants in 2 patient groups

Cataract Surgery Only
Active Comparator group
Treatment:
Procedure: Cataract Surgery
Treatment with Cataract Surgery & Stents
Experimental group
Description:
Ab interno trabecular micro-bypass stent surgery
Treatment:
Device: iStent Inject (GTS400)

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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