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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The cataract surgery will be performed first and if successful, only then will the MINIject be placed into supraciliary space.
Panama Eye Center
Panama City, Panama
Hospital Clínico San Carlos
Madrid, Spain
East Suffolk and North Essex NHS Foundation Trust - Colchester General Hospital
Colchester, Essex, United Kingdom
Princess Alexandra Eye Pavilion
Edinburgh, United Kingdom
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
Time frame: 6 months
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