Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

Glaukos

Status: Unknown

Conditions: Primary Open Angle Glaucoma

Treatments: Device: iStent; Procedure: Cataract surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT01841450

GTS100-PAS2 (Rev1 04-11-2016)

Details and patient eligibility

About

The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Full description

The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery compared to cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Enrollment: 360 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• mild to moderate primary open-angle glaucoma
• currently treated with ocular hypotensive medication
• pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
• subject scheduled to undergo cataract surgery

Exclusion criteria

• primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma
• retrobulbar tumor, thyroid eye disease, Sturge-Weber syndrome or any other type of condition that may cause elevated episcleral venous pressure

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

360 participants in 2 patient groups

iStent

Experimental group

Description:

Implantation of one iStent in conjunction with cataract surgery

Treatment:

Device: iStent

Cataract surgery

Active Comparator group

Description:

Cataract surgery alone

Treatment:

Procedure: Cataract surgery