MINIject in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool

iSTAR Medical

Status: Completed

Conditions: Glaucoma, Open-Angle; Glaucoma Eye

Treatments: Device: MINIject CS627 implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03996200

STAR-III (ISM08)

Details and patient eligibility

About

Study to assess safety and performance of MINIject SO627 in patients with open angle glaucoma.

Full description

The study will evaluate the efficacy and safety of MINI SO627 and IOP (Intra- ocular pressure) lowering effects with or without the use of glaucoma medications. The procedure will be a stand alone surgery. Patient follow up with several examinations up to 24 months after surgery.

The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
• Grade 3 or grade 4 according to Shaffer Angle Grading System.
• Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg < IOP < 35 mmHg in the study eye at baseline visit.

Exclusion criteria

• Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System in the study eye.
• Neovascular glaucoma in the study eye.
• Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye.
• Prior glaucoma surgery in the study eye.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

MINIject CS627 implant

Experimental group

Description:

MINIject 627 implant is used to reduce intra-ocular pressure in the eye. It is implanted through a minimally-invasive glaucoma surgical intervention in a stand alone procedure.

Treatment:

Device: MINIject CS627 implant