A Prospective, Open, Multicentre 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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- iSTAR Medical
- Enrollment
- 25
- Locations
- 3
- Primary Endpoint
- medicated diurnal IOP
Study Overview
Brief Summary
Study to assess safety and performance of MINIject SO627 in patients with open angle glaucoma.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
MINIject CS627 implant
MINIject 627 implant is used to reduce intra-ocular pressure in the eye. It is implanted through a minimally-invasive glaucoma surgical intervention in a stand alone procedure.
Intervention: MINIject CS627 implant (Device)
Outcomes
Primary Outcomes
medicated diurnal IOP
Time Frame: 6 months post surgery
Change in medicated diurnal IOP
Secondary Outcomes
No secondary outcomes reported