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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01455467

Enrollment

Registered

2011-10-20

Start date

2011-09-30

Completion date

2019-10-18

Last updated

2022-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-angle Glaucoma

Keywords

Open angle glaucoma, Pigmentary glaucoma, Pseudoexfoliative glaucoma

Brief summary

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.

Interventions

DEVICEOne iStent

Implantation of one iStent in conjunction with cataract surgery

DEVICETwo iStent

Implantation of two iStent in conjunction with cataract surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP	12 Months

Countries

Armenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026