Sight Sciences has started enrollment in the Gemini clinical study, a prospective, multi-center study to evaluate the safety and efficacy of the OMNI Surgical System for multiple micro-invasive glaucoma surgery (MIGS) procedures.
Sight Sciences said that the Omni Surgical System is capable of performing two sequential MIGS procedures, namely transluminal viscoelastic delivery and trabeculotomy.
The company has enrolled subjects with mild-to-moderate primary open angle glaucoma (POAG) and scheduled to undergo cataract surgery to participate in the study.
Vold Vision medical director Dr. Steve Vold has treated the first subject in the Gemini study to have surgery performed with the OMNI Surgical System in March 2019.
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. Our goal of intervening earlier in the disease stage with multiple mechanisms of action is to generate the most efficacies possible while maintaining the optimal safety profile of MIGS.
“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 company said that the Gemini study forms the largest clinical study ever to evaluate the OMNI Surgical System, with more than 130 subjects enroll from 10 to 15 medical centers in the United States.
As part of the study, the participants are to be followed for one year with an interim analysis performed at six months.
Sight Sciences said that OMNI surgical system facilitates numerous short and long-term benefits for the procedures transluminal viscoelastic delivery and trabeculotomy have been established through multiple studies.
The company claims that it has a growing compendium of clinical experience with devices totaling more than 14,000 procedures conducted, between the OMNI Surgical System and its predicate devices Trab360 and Visco360.
The procedures are expected to target the three potential points of resistance in the conventional outflow pathway, including trabecular meshwork, which accounts for approximately 60% of the resistance, Schlemm’s canal and the distal collector channels which make up approximately the other 40% of resistance.
Sight Sciences chief medical officer and board-certified ophthalmologist Dr. 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.”