Clinical Performance, Safety, And User Experience Of The Sophi® Phacoemulsification System In Cataract Surgery: A Prospective Single-Center Study

To prospectively evaluate the intraoperative efficiency, phacodynamic stability, postoperative visual outcomes, corneal endothelial safety, inflammatory response, and user experience associated with the Sophi® closed-fluidics phacoemulsification system in patients undergoing bilateral age-related cataract surgery. Primary endpoints included effective phacoemulsification time, cumulative dissipated energy, irrigation fluid usage, total surgical time, and postoperative visual acuity. Secondary endpoints included endothelial cell density, coefficient of variation, hexagonality, central corneal thickness, intraocular pressure, anterior chamber inflammation (SUN grading), complications, patient pain perception and surgeon-reported usability.

This prospective, single-center study was conducted at The Medical City Eye and Vision Institute, a tertiary ophthalmology center in the Philippines. All procedures were performed in a standardized operating suite by experienced cataract surgeons using uniform surgical techniques and postoperative protocols. Participants underwent sequential bilateral phacoemulsification within a 7-10 day interval, with structured follow-ups at 1 day, 1-2 weeks, 1 month, and 3 months postoperatively.

14 patients (28 eyes) with moderate nuclear sclerotic cataracts (LOCS III Gr 2-3+) underwent phacoemulsification using the Sophi® system. Pre- and postoperative assessments included ETDRS-based visual acuity, specular microscopy (ECD, coefficient of variation, hexagonality), central corneal thickness, intraocular pressure and SUN-based anterior chamber inflammation grading. Intraoperative metrics included EPT, CDE, irrigation fluid volume, torsional ultrasound amplitude, vacuum, aspiration flow rate, intraoperative IOP, phacoemulsification + I/A time and total surgical time. Patient pain and satisfaction surveys and surgeon usability questionnaires were administered. Outcomes were compared with baseline using appropriate statistical tests.

All 28 eyes completed the 3-month follow-up. Mean EPT was 5.68 ±2.17 seconds and mean CDE was 4.92 ±1.61, reflecting efficient energy utilization. Mean total surgical time was 15.4 ±2.3 minutes. UDVA improved from 0.48±0.21 to 0.06±0.08 logMAR at 1 month (p<0.001); CDVA improved from 0.32±0.18 to 0.02±0.05 logMAR (p<0.001). Mean ECD decreased by 5% at 1 month (p<0.05). Mean CCT increased transiently by 8-12 µm on Day 1-7, returning to near baseline by Month 1. Postoperative IOP remained stable. AC inflammation was mild (≤1+ SUN) and resolved by Week 2. No sight-threatening intraoperative or postoperative complications occurred. Patient pain scores were low, and surgeon-reported chamber stability and usability were rated highly favorable.

The Sophi® phacoemulsification system demonstrated efficient intraoperative energy delivery, stable fluidics, favorable endothelial safety, rapid visual recovery and excellent usability in routine bilateral cataract surgery. Observed endothelial cell loss and corneal thickness changes were within accepted clinical benchmarks and postoperative inflammation and complication rates were low. The system’s integrated fluidics architecture and automated parameter recording supported reproducible surgical performance and high surgeon satisfaction. These findings demonstrate consistent efficiency, stable fluidics and favorable safety outcomes, supporting the clinical utility of the Sophi® closed-fluidics platform in contemporary cataract surgery.