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MINIject Glaucoma Implant in European Patients | Clinical Trials | Clareo Health

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MINIject Glaucoma Implant in European Patients

A Prospective, Open, Multicentre Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in European Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

NCT03624361•iSTAR Medical

View on ClinicalTrials.gov

Summary

The study will evaluate the efficacy and safety of the MINIject glaucoma implant and Intraocular Pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.

Detailed Description

The primary endpoint is the 'qualified success' rate at 6 months after surgery greater than 60%. 'Qualified success' is defined as a diurnal IOP ≤ 21mmHg (millimeter mercury) and \> 5mmHg with a minimum 20% diurnal IOP reduction from baseline with or without the concomitant use of allowed glaucoma hypotensive medication at 6 months after surgery

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males or females, 50 years of age or older.
•Diagnosis of primary open angle glaucoma during screening visit or earlier.
•Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shafer Angle Grading System.

Exclusion Criteria

•Diagnosis of glaucoma other than primary open angle glaucoma (e.g. angle closure glaucoma or secondary open angle glaucoma) in the study eye.
•Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shafer Angle Grading System.
•Neovascular glaucoma in the study eye.
•Corneal opacity or iridocorneal angle not visible through gonioscopy prisma in the study eye, preventing correct placement of the implant.

Locations (8)

Center Hospotalier Universitaire Genoble Alpes

Grenoble, France

Hôpital de la Croix Rousse

Lyon, France

Ludwig-Maximilians-University Munich

Munich, Bavaria, Germany

Uni-Augenklinik Bochum

Bochum, North Rhine-Westphalia, Germany

Uniklinik Köln

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Mainz

Mainz, Rhineland-Palatinate, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Hospital Clínico San Carlos

Madrid, Spain

Key Dates

Start Date

May 23, 2018

Primary Completion Date

December 31, 2019

Completion Date

September 23, 2021

Last Updated

August 9, 2022

Enrollment

ACTUAL participants

Conditions

Glaucoma, Open-AngleGlaucoma EyeIntraocular Pressure

Interventions

Glaucoma device implantation in a stand-alone procedure

DEVICE

Feasibility Clinical Evaluation of the Calibreye System

NCT05885022

Glaucoma, Open-Angle

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RECRUITING

24-hour Wear Performance and Safety Study of Smartlens miLens Contact Lens for IOP Monitoring

NCT06689696

GlaucomaGLAUCOMA 1, OPEN ANGLE, D (Disorder)+9 more

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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: August 9, 2022Data 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.

View ClinicalTrials.gov Terms and Conditions

MINIject Glaucoma Implant in European Patients

Inclusion Criteria

Exclusion Criteria

Feasibility Clinical Evaluation of the Calibreye System

24-hour Wear Performance and Safety Study of Smartlens miLens Contact Lens for IOP Monitoring

Evaluation of Phacogoniotomy in Medically-controlled POAG

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

Upper Extremity Position and Intraocular Pressure During Spinal Anesthesia

Clinical Study for TONOREF III Tested to ANSI Z80.10-2014