Cataract, Primary Open-angle Glaucoma
Conditions
Keywords
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)
Brief summary
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
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.
Interventions
DEVICEPhacoemulsification combined with minimally invasive glaucoma surgery (MIGS)
The cataract surgery will be performed first and if successful, only then will the MINIject be placed into supraciliary space.
Sponsors
iSTAR Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP | 6 months | Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP from baseline to 6 months follow-up, with or without IOP lowering medications |
Countries
Panama, Spain, United Kingdom
Outcome results
None listed