OCT 19, 2017
The first human clinical trial to evaluate the MINIject glaucoma device has finished enrolling participants, according to a press release from developers iSTAR Medical.
Made of proprietary material, the MINIject is a porous silicone drainage tube that is implanted into the suprachoroidal space during a single-step, micro-invasive glaucoma surgery (MIGS). The material supposedly enhances bio-integration, fluid drainage and conformability to patient anatomy compared with previous MIGS devices—enabling safe and comfortable long-term aqueous humour outflow.
The multicenter, open-label trial recruited 25 subjects with mild to moderate open-angle glaucoma that was not controlled on topical hypotensive medications. Patients will be followed for 2 years after implantation, with initial safety and efficacy findings reported at 6 months.
"I am excited to be investigating this novel, next-generation, intuitive MIGS device with the iSTAR Medical team,” said Ike Ahmed, MD, of the University of Toronto. “MINIject offers the potential of an efficacious treatment which may be less fibrotic and thus more sustainable in the long-term."