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OpenTrials
Completed

NCT Number: NCT01517477

One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

The purpose of this study is to evaluate the safety and efficacy of the intraocular pressure (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on two anti-glaucoma medications.

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Key information

Conditions

Primary Open Angle Glaucoma (POAG) Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

S.V. Malayan's Ophthalmology Centre

Yerevan, 375108, Armenia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Diagnosed with primary open-angle glaucoma (POAG)
  • Subject on two topical hypotensive medications

Exclusion criteria

  • Traumatic, uveitic, neovascular, or angle closure glaucoma
  • Fellow eye already enrolled

Treatment and study plan

iStent

Device

Implantation of One iStent through a small temporal clear corneal incision.

Primary outcomes

  1. Mean diurnal intraocular pressure (IOP) reduction of greater than or equal to 20% at month 12 vs. baseline

    Time frame: 12 Months

Secondary outcomes

  1. Mean diurnal IOP <18 mmHg at month 12

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

A Prospective, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Jan 25, 2012
Registry last updated
Aug 31, 2022

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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