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OpenTrials
Completed

NCT Number: NCT00911924

A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma

Prospective, unmasked, evaluation of the iStent in patients that have primary open-angle glaucoma (OAG). Stent implantation in one eye will be used for analysis, with medication added at 6 months, as required.

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Key information

Conditions

Glaucoma Eye Diseases Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

S.V. Malayan's Ophtalmology Centre, Yerevan, Armenia

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About this study

One hundred patients will be enrolled in the study at up to 21 sites; follow-up is through 1 year.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of primary open-angle glaucoma
  • Male or female at least 18 years of age and able to provide written informed consent
  • Mean IOP (at baseline visit after washout of any medications) must be at least 22 mm Hg and no greater than 38 mm Hg
  • Likely to be available and willing to attend follow-up visits

Exclusion criteria

  • Angle closure glaucoma
  • Secondary glaucomas
  • Prior glaucoma procedures
  • Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease

Treatment and study plan

iStent

Device

Glaukos iStent, medication

Other names: stent, trabecular micro-bypass stent

Primary outcomes

  1. IOP 18 mm Hg or less without medications

    Time frame: At 6 months

  2. IOP 18 mm Hg or less with or without medications

    Time frame: 12 months

Secondary outcomes

  1. Mean IOP

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Acronym: SY

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 3, 2009
Registry last updated
May 20, 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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