Safety and Effectiveness Study of MINIject S Implant for Open Angle Glaucoma Using Different Insertion Tools

What this Trial Is About

Researchers are evaluating the safety, usability, implantation accuracy, and effectiveness of the MINIject S device in adults with open angle glaucoma. This study involves multiple centers across several countries and includes a first-in-man phase to identify the best insertion tool for the device. The trial also assesses the chosen tool in patients who have both glaucoma and operable cataracts undergoing combined surgery. The study is divided into two parts. Part 1 compares three different versions of the insertion tool to implant the MINIject S device into the supraciliary space, with participants and evaluators unaware of which tool is used. Part 2 expands the study to a larger group using the selected insertion tool during combined glaucoma and cataract surgery with intraocular lens implantation. Each participant receives one version of the investigational device. Participants will undergo assessments including checking device placement accuracy one week after surgery and evaluating ease of use during the procedure. Additional follow-up visits at 6, 12, and 24 months will measure changes in visual acuity, intraocular pressure, medication use, endothelial cell density, and rates of secondary surgeries and adverse events. Participants must be able to follow study instructions and attend scheduled visits. The study lasts until July 2028, with primary outcome data expected by August 2026.

A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma