Sight Sciences has begun enrolment procedures for the Gemini clinical trial.
The study will evaluate the safety and efficacy of the OMNI Surgical System for use in micro-invasive glaucoma surgery (MIGS), including transluminal viscoelastic delivery and trabeculotomy procedures.
The system is designed to deliver small amounts of viscoelastic fluid during ophthalmic surgery and can be used to cut trabecular meshwork tissue during a trabeculotomy.
Mild-to-moderate primary open angle glaucoma (POAG) patients that are set to undergo cataract surgery will be invited to take part in the trial. A total of up to 130 subjects will be enrolled at ten to 15 centres across the US.
The study involves a one year follow-up period and interim analysis will be carried out at six months.
The first subject in the study was treated at Vold Vision medical centre. Director Steve Vold said: “Through this rigorously designed study, we hope to further validate the long-term treatment benefits associated with performing multiple MIGS procedures during one surgery.
“The OMNI Surgical System targets the three points of resistance in the conventional outflow pathway; this medical technology has the potential to become a leading option in the MIGS space.”
The OMNI System allows surgeons to target the trabecular meshwork, Schlemm’s canal and distal collector channels, which are the three points of resistance in the conventional outflow pathway. The device’s short and long term benefits have been validated in several studies.
Sight Sciences chief medical officer Reay Brown said: “Sight Sciences is committed to building upon a strong foundation of scientific evidence to help inform surgeons’ clinical decisions and help them select technologies that are best suited for their individual patients.
“We look forward to further confirming, via this large-scale, prospective, multicenter trial, that our sophisticated technology offers a compelling alternative to traditional treatments.”
The company’s portfolio also includes a non-surgical dry eye product called TearCare, which is a software-controlled, wearable eyelid technology to deliver thermal energy to the meibomian glands.