A Prospective, Open, Multicentre Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in European Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glaucoma, Open-Angle
- Sponsor
- iSTAR Medical
- Enrollment
- 29
- Locations
- 8
- Primary Endpoint
- Qualified success for lowering the IOP
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The study will evaluate the efficacy and safety of the MINIject glaucoma implant and Intraocular Pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.
Detailed Description
The primary endpoint is the 'qualified success' rate at 6 months after surgery greater than 60%. 'Qualified success' is defined as a diurnal IOP ≤ 21mmHg (millimeter mercury) and \> 5mmHg with a minimum 20% diurnal IOP reduction from baseline with or without the concomitant use of allowed glaucoma hypotensive medication at 6 months after surgery
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males or females, 50 years of age or older.
- •Diagnosis of primary open angle glaucoma during screening visit or earlier.
- •Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shafer Angle Grading System.
Exclusion Criteria
- •Diagnosis of glaucoma other than primary open angle glaucoma (e.g. angle closure glaucoma or secondary open angle 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 Shafer Angle Grading System.
- •Neovascular glaucoma in the study eye.
- •Corneal opacity or iridocorneal angle not visible through gonioscopy prisma in the study eye, preventing correct placement of the implant.
Outcomes
Primary Outcomes
Qualified success for lowering the IOP
Time Frame: at 6 months
The primary objective is the 'qualified success' rate at 6 months after surgery greater than 60%. 'Qualified success' is defined as a diurnal IOP ≤ 21 mmHg and \> 5 mmHg with a minimum 20% diurnal IOP reduction from baseline with or without the concomitant use of allowed glaucoma hypotensive medication at 6 months after surgery
Secondary Outcomes
- Safety assessment of device in terms of adverse events (AEs) and serious adverse events (SAEs) reported during duration of study(up to 24 months after surgery)