A Multicenter Time And Motion Study Assessing The Efficiency Impact Of The Next Generation Of Phacoemulsification System On Cataract Surgery

UNITY™ Vitreoretinal Cataract System (UNITY VCS) received US-FDA 510k clearance in June 2024. The UNITY VCS console ophthalmic system is indicated for use during both anterior segment and posterior segment ophthalmic surgery. This real-world, prospective, multicenter, comparative time and motion study aimed to evaluate the impact of UNITY VCS cataract functionality compared to CENTURION™ Vision System with ACTIVE SENTRY™ (CENTURION with AS) on surgical workflow efficiency, including the duration of set-up and tear-down activities. 

Two ambulatory surgery centers located in Atlanta, GA and Los Angeles, CA.

240 cataract procedures at two US ambulatory surgical centers (Georgia, California) performed by four surgeons on adult patients with non-complicated age-related cataracts will be enrolled. Prospective observational data will be collected via videographic analysis. Outcomes include comparisons of console set-up time (primary endpoint), overall procedure duration (sterile field set-up, phacoemulsification, and sterile field tear-down time) and surgery turnover time (secondary endpoints). Exploratory outcomes include proxy measures of procedural efficiency (CDE, BSS fluid use, and ultrasound time), OR staff utilization rates, and perceived workload of OR staff. Descriptive and comparative statistical analyses will be performed.

Enrollment, data collection, and video analysis are currently ongoing with statistical analyses planned once all data are available. For the baseline CENTURION with AS arm, interim data for 77 cases were analyzed. The mean age of patients was 69.6 years, and most patients had a cataract density of 2+ (81.8%). Femtosecond laser and image guidance systems were used in 28.6% of cases. Mean console set-up time was 5.60 ± 2.13 minutes and mean surgery turnover time was 12.09 ± 3.55 minutes in the CENTURION with AS arm. Final results will be presented comprising the full cohort of 240 subjects from both sites.

This study will offer real-world OR insights into potential procedural efficiencies associated with UNITY VCS compared to CENTURION with AS. Future analyses will determine if the UNITY VCS console is associated with increased OR procedure efficiency compared to CENTURION with AS. With aging populations, increased demand for cataract surgery is anticipated in addition to the current challenge with surgical backlog and waitlists. Time savings associated with increased OR efficiencies may help practices to address the current backlog and future demand for cataract procedures.