MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract (STAR-VI)

iSTAR Medical

Status

Invitation-only

Conditions

Cataract

Primary Open-angle Glaucoma

Treatments

Device: Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05432245

STAR VI

Details and patient eligibility

About

The study will assess safety and performance of MINIject implant in patients with open-angle glaucoma uncontrolled by topical hypotensive medications in conjunction with cataract surgery.

Full description

The study aims to evaluate the safety and efficacy of the MINIject in the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) in conjunction with cataract surgery. The cataract surgery will be performed first and if successful, only then will the MINIject be placed.

Patients will be followed for 2 years after the date of their implantation. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.

Enrollment

30 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of primary open angle glaucoma (POAG) in the study eye
Operable age-related cataract eligible for phacoemulsification surgery with Intraocular Lens (IOL) implantation
Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the patient has an allergy / intolerance to a medication
Patient must provide written informed consent to participate

Exclusion criteria

Known or suspected allergy or hypersensitivity to medical silicone
Allergy to fluorescein
Presence of silicone oil in the study eye
Individuals under tutorship or trusteeship
Patient has a condition such that his / her ability to provide personal informed consent is compromised