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

Glaukos

Status: Completed

Conditions: Open-angle Glaucoma

Treatments: Device: Two iStent; Device: One iStent

Study type: Interventional

Funder types: Industry

Identifiers

NCT01455467

GCF-024

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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79 participants in 2 patient groups

One iStent

Active Comparator group

Description:

Implantation of one iStent in conjunction with cataract surgery

Treatment:

Device: One iStent

Two iStent

Active Comparator group

Description:

Implantation of two iStent devices in conjunction with cataract surgery

Treatment:

Device: Two iStent