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COMPLETEDNANCT03996200

MINIject in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool

Study to assess safety and performance of MINIject SO627 in patients with open angle glaucoma.

Lead sponsor: iSTAR Medical•3 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

iSTAR Medical

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.

Age

18 - No limit years

Sex

ALL

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 3, 2023Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment25

Start dateJul 2019

Last updatedMay 3, 2023

Condition

Glaucoma, Open-Angle Glaucoma Eye

Locations shown

Clinica Oftalmologica del Caribe

Barranquilla

Maxivision Eye Hospital

Hyderabad, Telangana

Panama Eye Center

Panama City

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2023Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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