NCT05432245

MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract

A Prospective, Open, Multicenter Clinical Trial Evaluating the Efficacy and Safety of MINIject Combined With Cataract Surgery in Patients With POAG Uncontrolled by Topical Hypotensive Medications and Operable Age-related Cataract Diagnosis

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: iSTAR Medical · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The study will assess safety and performance of MINIject implant in patients with open-angle glaucoma uncontrolled by topical hypotensive medications in conjunction with cataract surgery.

Detailed description

The study aims to evaluate the safety and efficacy of the MINIject in the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) in conjunction with cataract surgery. The cataract surgery will be performed first and if successful, only then will the MINIject be placed. Patients will be followed for 2 years after the date of their implantation. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.

Conditions

• Primary Open-angle Glaucoma
• Cataract

Interventions

Type	Name	Description
DEVICE	Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS)	The cataract surgery will be performed first and if successful, only then will the MINIject be placed into supraciliary space.

Timeline

• Start date: 2023-01-18
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2022-06-27
• Last updated: 2025-02-28

Locations

4 sites across 3 countries: Panama, Spain, United Kingdom