NCT03624361

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: iSTAR Medical · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Conditions

• Glaucoma, Open-Angle
• Glaucoma Eye
• Intraocular Pressure

Interventions

Type	Name	Description
DEVICE	Glaucoma device implantation in a stand-alone procedure	MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery.

Timeline

• Start date: 2018-05-23
• Primary completion: 2019-12-31
• Completion: 2021-09-23
• First posted: 2018-08-10
• Last updated: 2022-08-09

Locations

8 sites across 3 countries: France, Germany, Spain