Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery

Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.

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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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation
Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)

Exclusion criteria

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

Treatment and study plan

One iStent

Device

Implantation of one iStent in conjunction with cataract surgery

Two iStent

Device

Implantation of two iStent in conjunction with cataract surgery

Primary outcomes

Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP

Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery

Important dates

Study start: 2011
Primary completion: 2019
Study completion: 2019
First posted: Oct 20, 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.

Published trials that share one or more normalized conditions with this study.

Completed