Health Condition 1: null- PATIENTS WITH OPEN ANGLE GLAUCOMA UNCONTROLLED BY TOPICAL HYPOTENSIVE MEDICATIONS
Conditions
Interventions
Intervention1: MINIject: MINIject is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant and a Delivery Tool. Patients will be followed up for 24 months
Control Intervention
Sponsors
iSTAR Medical SA
Eligibility
Inclusion criteria
Inclusion criteria: • Males or females, 18 years of age or older. • Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier. • Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System. • Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg • Patients must be willing and able to return for scheduled study-related examinations. • Patients must provide written informed consent.
Exclusion criteria
Exclusion criteria: • Diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye. • Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System. • Neovascular glaucoma in the study eye. • Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant. • Prior glaucoma surgery in the study eye. Patient treated with argon laser trabeculoplasty or selective laser trabeculoplasty in the study eye are eligible if treatment was performed >= 90 days before screening visit. • Visual field defect in the 10-degree central field in the study eye. • Anticipated need for ocular surgery or retinal laser procedure in the study eye 12 months following surgery. • Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye. • Pre-existing ocular or systemic pathology that, in the opinion of the physician, is likely to cause postoperative complications following implantation of the device in the study eye. • Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye. • Pre-existing ocular or systemic pathology that, in the opinion of the physician, is likely to cause postoperative complications following implantation of the device in the study eye. • Evidence of crystalline lens subluxation or luxation in the study eye. • Evidence of vitreous loss in the anterior chamber in the study eye. • Clinically significant intra-ocular inflammation or infection, presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis, active proliferative/inflammatory retinopathy in the study eye. • Presence of silicone oil in the study eye. • Patients treated with systemic acetazolamide within 3 days before screening. • Patient with poor vision (LogMar score: +1.0) in non-study eye, unless there is an expected benefit for the study eye in the opinion of the investigator. • Participation in any study involving an investigational drug or device within the past 3 months. • Only for women of childbearing potential: positive urine pregnancy test at screening. • Individuals under tutorship or trusteeship.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in medicated mean diurnal IOP at 6 months follow-up compared to medicated diurnal IOP at screening visitTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute and relative reduction (in %) of medicated diurnal IOP compared to medicated diurnal IOP at screening visit.Timepoint: Day 1, Week 1, Week 2, Month 1, Month 3, Month 6, Month 12, Month 18, Month 24 | — |
Countries
India, Panama
Contacts
Public ContactMr Naresh Kumar Pagidimarry
Maxivision Super Speciality Eye Hospital
Outcome results
None listed