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

iSTAR Medical3 sites in 3 countries25 target enrollmentJuly 23, 2019

ConditionsGlaucoma, Open-Angle Glaucoma Eye

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Glaucoma, Open-Angle
Sponsor: iSTAR Medical
Enrollment: 25
Locations: 3
Primary Endpoint: medicated diurnal IOP
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

July 23, 2019

End Date

February 10, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

iSTAR Medical

Responsible Party

Sponsor

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.