MINIject Glaucoma Implant in European Patients (STAR-II)

iSTAR Medical

Status: Completed

Conditions: Intraocular Pressure; Glaucoma, Open-Angle; Glaucoma Eye

Treatments: Device: Glaucoma device implantation in a stand-alone procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT03624361

STAR-II (ISM04EU)

Details and patient eligibility

About

The study will evaluate the efficacy and safety of the MINIject glaucoma implant and Intraocular Pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.

Full description

The primary endpoint is the 'qualified success' rate at 6 months after surgery greater than 60%. 'Qualified success' is defined as a diurnal IOP ≤ 21mmHg (millimeter mercury) and > 5mmHg with a minimum 20% diurnal IOP reduction from baseline with or without the concomitant use of allowed glaucoma hypotensive medication at 6 months after surgery

Enrollment: 29 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females, 50 years of age or older.
• Diagnosis of primary open angle glaucoma during screening visit or earlier.
• Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shafer Angle Grading System.

Exclusion criteria

• Diagnosis of glaucoma other than primary open angle glaucoma (e.g. angle closure glaucoma or secondary open angle glaucoma) in the study eye.
• Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shafer Angle Grading System.
• Neovascular glaucoma in the study eye.
• Corneal opacity or iridocorneal angle not visible through gonioscopy prisma in the study eye, preventing correct placement of the implant.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Stand-alone

Experimental group

Description:

Patients will receive MINIject Glaucoma implant in a stand-alone procedure. MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention.

Treatment:

Device: Glaucoma device implantation in a stand-alone procedure