A Prospective, Open, Clinical Trial Analysing The Efficacy and Safety of MINIJECT (MINI SO627) In Patients With Open Angle Glaucoma Uncontrolled By Topical Hypotensive Medications Using A Single Operator Delivery Tool
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glaucoma, Open-Angle Glaucoma Eye
- Sponsor
- iSTAR Medical
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- Change in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The study will assess safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.
Detailed Description
The study will evaluate the efficacy and safety of MINI SO627 and IOP (Intra- ocular pressure) lowering effects with or without the use of glaucoma medications. The procedure will be a stand alone surgery. Patient follow up with several examinations up to 24 months after surgery. The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
- •Grade 3 or grade 4 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 \< IOP \< 35 mmHg in the study eye at baseline visit.
Exclusion Criteria
- •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 in the study eye.
- •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 in the stud eye.
- •Prior glaucoma surgery in the study eye.
Outcomes
Primary Outcomes
Change in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up
Time Frame: 6 month post surgey
The primary endpoint of the study is the reduction in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up compared to medicated or unmedicated (without washout) diurnal IOP at baseline visit.