MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract

A Prospective, Open, Multicenter Clinical Trial Evaluating the Efficacy and Safety of MINIject Combined With Cataract Surgery in Patients With POAG Uncontrolled by Topical Hypotensive Medications and Operable Age-related Cataract Diagnosis

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.

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.

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