Evaluation Of A Phacoemulsification Handpiece With A Built-In Fluidics Pressure Sensor: The Sasca Multicenter Study (Study Of Active Sentry In Cataract Surgery)

The prevention of pressure fluctuations in the anterior chamber is an important factor for the safety of cataract surgery. Modern phacoemulsifiers are designed to prevent occlusion break surges to stabilize the anterior chamber. We compared phacoemulsifications performed with a pressure sensor built in the handpiece (Active Sentry®) with procedures using a traditional sensor placed in the phacoemulsifier. Our primary objective was to assess whether the effect of the immediate pressure adjustments provided by the Active Sentry system could result in a reduction of the energy used during phacoemulsification.

The SASCA study (Study of Active Sentry in CAtaract surgery) was a multicenter prospective clinical trial (ClinicalTrials.gov Identifier: NCT04732351). The study involved 4 surgeons in 3 French centers (2 private practices and 1 university hospital). All participants used the Centurion® phacoemulsification system in real life conditions alternatively with the handpiece-based sensors (Active Sentry system) or with the traditional phacoemulsifier-based sensors.

The following preoperative data were recorded: age, best-corrected visual acuity, axial length, anterior chamber depth and nuclear opacities based on the WHO grading scale. Consecutive procedures were performed alternatively with Centurion phacoemulsifiers using Active Sentry (AS) or non-Active Sentry (non-AS) handpieces. The primary outcome measure was the mean Cumulated Dissipated Energy (CDE) during the procedures. Secondary outcome measures were the total procedure duration, the total ultrasound time (US time) and the frequency of adverse events. These parameters were also analyzed according to the cataracts’ grades. This interim analysis was planned at 50% of inclusions with a significance level of 0.54% to account for risk inflation.

This was an interim assessment based on the study’s first 988 cases (551 AS and 437 non-AS). The mean patient age was 72.7 ± 9.8 years. The nuclear cataract grades were 0-1 in 347 (35.1%), 2 in 484 (49.0%), 3 in 139 (14.1%) and unrecorded in 18 (1.8%) cases. There were no differences between the AS and non-AS groups at baseline. The median CDE was respectively 6.2 (range 3.7-9.8) and 6.7 (4.6-12.3) with AS and without AS (p=0.0001). This significant lower CDE was consistent within each cataract grades. The median US time was respectively 48.0 (range 35.0-69.0) and 57.0 (39.0-84.5) with and without AS (p<.0001). Both torsional and longitudinal US time were reduced with AS. No adverse events were recorded in either group.

 

The analyses confirmed that phacoemulsification with Active Sentry significantly reduced the amount of energy used during the procedures and shortened their duration. Although in our study no complications were recorded in either group, on a larger scale we anticipate that the significant energy reduction linked to using the AS system will increase the overall safety of cataract surgery. The benefits of the AS-based low energy strategy for phacoemulsification will be further investigated.

This work was supported by an investigator-initiated study grant funded by Alcon (IIT#57203277). APB, DM, FL and PR are consultants for Alcon.