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MINIject Glaucoma Implant in European Patients — STAR-II  

Glaucoma, Open-Angle Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03624361
Study type Interventional
Source iSTAR Medical
Contact
Status Completed
Phase N/A
Start date May 23, 2018
Completion date September 23, 2021
View Details
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