Multicenter Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery

A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01461278

Enrollment

505

Registered

2011-10-28

Start date

2011-12-22

Completion date

2020-03-12

Last updated

2022-05-19

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

Conditions

Primary Open-angle Glaucoma

Keywords

Primary open-angle glaucoma, POAG, Cataract surgery, Suprachoroidal space, Suprachoroidal stent, iStent supra

Brief summary

Evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Detailed description

This is an IDE trial to evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 (hereinafter referred to as G3) in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Interventions

DEVICEiStent supra

Cataract surgery and implantation of one iStent supra

PROCEDURECataract surgery

Cataract surgery alone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

* Mild to moderate open-angle glaucoma * Characteristics consistent with mild to moderate glaucoma * Use of one (1) to three (3) medications at time of screening exam

Exclusion criteria

* Pigmentary or pseudoexfoliative glaucoma * Prior incisional glaucoma surgery

Design outcomes

Primary

Measure	Time frame
≥ 20% Reduction in Intraocular Pressure (IOP)	Baseline and Month 24

Secondary

Measure	Time frame
Diurnal IOP Reduction from Baseline	Baseline and Month 24

Countries

United States

Outcome results

None listed

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