A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma (SY)

Glaukos

Status and phase: Completed; Phase 4

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

Treatments: Device: iStent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00911924

Synergy Trial

Synergy

Details and patient eligibility

About

Prospective, unmasked, evaluation of the iStent in patients that have primary open-angle glaucoma (OAG). Stent implantation in one eye will be used for analysis, with medication added at 6 months, as required.

Full description

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

Enrollment: 112 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 at least 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

iStent

Experimental group

Treatment:

Device: iStent