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MINIject in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool | Clinical Trials | Clareo Health

COMPLETEDNA

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

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

NCT03996200•iSTAR Medical

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (3)

Clinica Oftalmologica del Caribe

Barranquilla, Colombia

Maxivision Eye Hospital

Hyderabad, Telangana, India

Panama Eye Center

Panama City, Panama

Key Dates

Start Date

July 23, 2019

Primary Completion Date

February 14, 2020

Completion Date

February 10, 2022

Last Updated

May 3, 2023

Enrollment

ACTUAL participants

Conditions

Glaucoma, Open-AngleGlaucoma Eye

Interventions

MINIject CS627 implant

DEVICE

Feasibility Clinical Evaluation of the Calibreye System

NCT05885022

Glaucoma, Open-Angle

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RECRUITINGNA

Evaluation of Phacogoniotomy in Medically-controlled POAG

NCT06201455

Glaucoma, Open-AngleCataract Complicated+1 more

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RECRUITINGNA

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: March 29, 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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MINIject in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool

Inclusion Criteria

Exclusion Criteria

Feasibility Clinical Evaluation of the Calibreye System

Evaluation of Phacogoniotomy in Medically-controlled POAG

Results of Patients With Glaucoma Undergoing Minimally Invasive Glaucoma Surgery in Conjunction With Cataract Surgery

Evaluating Home Testing Devices for the Management of Glaucoma

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