A First-In-Human Clinical Investigation Using The Polaris System To Conduct Robot-Assisted Cataract Surgery With Intraocular Lens Implantation

This was a first-in-human clinical investigation of robot-assisted cataract surgery using the Polaris System (Horizon Surgical Systems, Inc.). The Polaris System is designed to be used by the surgeon for enhanced visualization of anterior segment structures while performing surgical procedures from corneal incision to intraocular lens implantation via surgical cockpit.

The study was conducted at a private ophthalmology clinic in El Salvador.

Adult patients with planned cataract surgery were recruited for the study. After giving written informed consent, subjects were evaluated for eligibility according to the inclusion and exclusion criteria  Eligible subjects were to undergo unilateral femtosecond laser-assisted cataract surgery in the study eye. The surgeon was to use the Polaris System to visualize the anterior segment while remotely controlling the robotic arm, which held standard surgical instruments used in routine cataract surgery.  Surgical procedures included incision placement, removal of the crystalline lens by phacoemulsification, and intraocular lens implantation. Ten consented eligible subjects successfully underwent unilateral cataract surgery with IOL implantation in the study eye.  Subjects ranged from 52 to 71 years of age, with a mean age of 62.8 years.

All surgical procedures were successfully completed for 10 eyes using the Polaris system, with no conversions from robot-assisted to manual, and no surgical complications.  One observation was noted for a subject with an anatomical challenge for surgical access, but surgery was completed uneventfully. There were no adverse events, slit lamp findings were within normal limits, and all subjects had good visual acuity outcomes (BCDVA 20/28 or better) through 1 month of postoperative follow-up. 

The Polaris System was successfully used to complete robot-assisted cataract surgery, which resulted in no adverse events and excellent visual outcomes through 1 month postoperative.