Testing a novel device for accurate ultrasound delivery during crystalline lens phacoemulsification surgery

Rossi Tommaso;Saffioti S.;Angelini G.;Querzoli G.;Telani S.;Rossi A.;Ripandelli G.

2020-01-01

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Abstract

Purpose: To assess whether the use of a patented, novel feedback device intended to accurately control phacoemulsification tip elongation is effective under varying machine settings and material resistance. Methods: Sculpt mode phaco (550-mm Hg Venturi pump; elongations, 35 and 70 μm) and quadrant settings (550-mm Hg Venturi pump; elongations, 15, 30, and 60 μm) were used in agar gel of incremental density (1%, 2%, 3%, and 6% in demineralized water). Dispersed lens fragments were also simulated with 6% agar gel spherules (2–5 mm in diameter; 550-mm Hg vacuum, and 60-μm elongation). Actual phaco tip elongation was measured on voltage readings from the piezoelectric crystals and compared to nominal elongation with feedback control off and on. Results: Mismatch between nominal and actual elongation when feedback control was off in sculpt mode varied between –13.51 μm and –23.07 μm of nominal elongation; in quadrant mode, mismatch varied between –2.79 μm and –20.41 μm. When the feedback control system was switched on, mismatch varied between –0.02 μm and +0.43 μm (P < 0.001 for all matchings). When the feedback system was off, the elongation mismatch among the 1%, 3%, and 6% agar was also statistically significant (P < 0.001). Elongation was 44.72 ± 4.16 μm with feedback control off and 60.02 ± 1.63 μm with it on (nominal elongation 60 μm; P < 0.001) when emulsifying agar 6% gel fragments. Dispersion of elongation data was also significantly wider when feedback control was turned off. Conclusions: A novel feedback control system effectively controls elongation accuracy regardless of the resistance offered by incremental agar gel concentrations. Translational Relevance: Implementing feedback control in phaco handpieces dramatically improves surgical accuracy. The translational value of this research relies on its immediate applicability to routine cataract surgery, resulting in a more appropriate use of ultrasound energy.