Santa Rosa De Copan

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.

Researchers are evaluating a canaloplasty device for people with open-angle glaucoma undergoing cataract surgery. The study aims to assess the safety and effectiveness of this device in managing eye pressure in this condition. This first-in-human trial is conducted by New World Medical, Inc. and is designed to provide important information about this surgical system. Participants will be treated with a US FDA-approved canaloplasty device during their cataract surgery. The study focuses on how the device affects intraocular pressure IOP and the need for IOP-lowering medications over time. There is one treatment group involving the use of this canaloplasty and trabeculotomy surgical system. During the study, participants will have their intraocular pressure measured, with the main outcome being the change in IOP one year after surgery. Researchers will also monitor IOP levels and medication use at 12 months. The study begins in September 2025 and continues through October 2027, involving regular follow-up visits to track safety and effectiveness results.