Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty

Glaukos

Status: Completed

Conditions: Open-angle Glaucoma

Treatments: Device: iStent; Other: SLT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01444105

GCF-028

Details and patient eligibility

About

Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

Full description

Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Phakic study eye or study eye with a posterior chamber intraocular lens (PC-IOL)
• Primary open-angle glaucoma (including pseudoexfoliative)

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

iStent

Active Comparator group

Description:

implantation of two iStent devices

Treatment:

Device: iStent

SLT

Active Comparator group

Description:

Laser treatment

Treatment:

Other: SLT