Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG) (SL)

Glaukos

Status and phase: Completed; Phase 4

Conditions: Glaucoma; Eye Diseases; Glaucoma, Open-Angle

Treatments: Drug: latanoprost/timolol; Device: iStent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913029

Second Line

Second Line Trial (Other Identifier)

Details and patient eligibility

About

Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.

Full description

Two hundred patients will be enrolled in the study at up to 21 clinical sites; follow-up is through 1 year.

Enrollment: 192 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of primary open-angle glaucoma
• Male or female at least 18 years of age and able to provide written informed consent
• Mean IOP (at baseline visit after washout of any medications) must be 22 mm Hg and no greater than 38 mm Hg
• Likely to be available and willing to attend follow-up visits

Exclusion criteria

• Angle closure glaucoma
• Secondary glaucomas
• Prior glaucoma procedures
• Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 2 patient groups

Stent

Active Comparator group

Description:

One hundred patients will be randomized to implantation of two G2 stents in at least one eye.

Treatment:

Device: iStent

Medication

Active Comparator group

Description:

One hundred patients will be randomized to receive a fixed combination ocular hypotensive medication.

Treatment:

Drug: latanoprost/timolol