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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Primary Open-angle Glaucoma, Cataract

Intervention / Treatment
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* Device: Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br> | Device: Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS)<br>* The cataract surgery will be performed first and if successful, only then will the MINIject be placed into supraciliary space.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP | Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP from baseline to 6 months follow-up, with or without IOP lowering medications | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Open-angle Glaucoma (POAG), Cataract, Intra Ocular Pressure (IOP) reduction, Glaucoma Drainage Device, Minimally Invasive Glaucoma Surgery (MIGS), Supraciliary space, Combined procedure (POAG and phacoemulsification)