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OpenTrials
Completed

NCT Number: NCT01444105

Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty

Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

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Key information

Conditions

Open-angle Glaucoma 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 Ophthalmological Center

Yerevan, 0001, Armenia

About this study

Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Phakic study eye or study eye with a posterior chamber intraocular lens (PC-IOL)
  • Primary open-angle glaucoma (including pseudoexfoliative)

Exclusion criteria

  • Aphakic or pseudophakic with anterior chamber IOLs (AC-IOLs) (study eye)
  • Prior stent implantations (study eye)

Treatment and study plan

iStent

Device

Implantation of two iStent devices

SLT

Other

Laser treatment

Primary outcomes

  1. Change from baseline in mean diurnal IOP (mm Hg) at the Month 12 visit.

    Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

A Prospective, Randomized, Controlled, Parallel Groups Evaluation of Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Sep 30, 2011
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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