Young Jeung Park, M.D. Ph.D. Won Suk Choi, M.D.

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Continuous-Mode Versus Custom-Pulse Mode Phacoemulsification of Hard Nucleus Young Jeung Park, M.D. Ph.D. Won Suk Choi, M.D. Kyoo Won Lee, M.D. Ph.D. Cheil Eye Hospital , Daegu, Korea Financial Disclosure: All authors declares no financial interest 2010 ASCRS Annual Meeting, Boston, Massachusetts

Background and purpose OZil® continuous mode has following advantages: Reduction of repulsion and chattering during phacoemulsification resulting in increased efficacy , and reduction of tissue damage by reducing heat generation. There are some reports describing the superiority of Ozil ® torsional phacoemulsification over conventional phacoemulsification in soft~ medium-hard nucleus. In case of hard nucleus, Ozil ® torsional phacoemulsification presents disadvantages due to difficulty in initial impalement, resulting in difficult chopping, and induces clogging effect during phacoemulsification. Ozil ® custom pulse mode is conventional phacoemulsification mixed into the main mechanism of Ozil ® torsional mode To compare short-term post-operative results in OZil ® continuous mode versus OZil ® custom pulse mode phacoemulsification in cataract patients with hard nucleus.

Materials and Methods Prospective study Patients having cataract with Lens Opacities Classification System III( above NO5,NC5) and a corneal endothelial count greater than 2000 cells/mm2 (49 patients, 53 eyes) Patients were excluded if they had other eye or general disorders affecting their vision; eg, diabetic retinopathy, glaucoma, uveitis, or previous intraocular surgery. Phaco system: OZil ®, Infiniti Vision System, Alcon Labs Group 1: OZil ® continuous mode in 24 patients (25 eyes) Group 2: OZil ® custom pulse mode in 25 patients (29 eyes) All surgeries were performed by the one surgeon with lots of experience (Y J Park). Chylack LT, et al. The Lens Opacities Classification System III. The Longitudinal Study of Cataract Study Group. Arch Ophthalmol. 1993 Jun;111(6):831-6.

Evaluations US time (UST), US%, aspiration time, estimated fluid used, and cumulative dissipated energy (CDE) were compared in the above two groups. Post-op central corneal thickness (CCT), endothelial cell count, and corneal clarity were compared at pre-op, 1day, 3days post-op, 1 week, 2weeks, 1month, 2months, and 3month post-op. Statistics: Mann-Whitney U-test: p˂ 0.05

Surgical parameters used in the study with Infiniti phacoemulsification platform Group 1† Group 2‡ Incision size (mm) 2.8 Continuous capsulorrhexis diameter (mm) 5.0-5.5 Phacoemulsification tip(0.9mm micorotip ABS) Mini-flared 45° Kelman ,Bevel down Mini-flared 45° Kelman, Bevel down Chopping technique Counter prechop + Horizontal chop Viscoelastic material(OVD): Hyal 2000®‡ 1% sodium hyaluronate Settings Phaco Power (%) / Torsional amplitude (%) • / 100 30~60 / 100 Aspiration flow (cm3/minute) 35 Vacuum (mmHg) 400 Mode/dynamic rise Continuous /0 Custom-pulse/0 Phaco (on/off) (msec) • 50 / 0 Ultrasonic oscillations (on/off) (msec) 150 / 0 † Group 1= OZil ® continuous mode phacoemulsification ‡ Group 2= OZil ® custom pulse mode phacoemulsification # Hyal 2000 ®, LG life science, Korea

Results Patients characteristics (mean±SD) Group 1† Group 2‡ p-value§ Eye(Patients) 25(24) 29(25) 0.36 Gender (male / female) 10 / 14 5 / 20 0.98 AGE (range) (years) 77.1±8.7 (60~97) 75.5±9.4(56~94) Mean nucleus density 5.3±0.5 Central corneal thickness(µm) 531.7±28.6 526.5±31.8 0.44 Endothelial cell count(cell/mm2 ) 2472±371 2514±302 0.78 Comparison of mean surgical parameters between OZil ® continuous mode and OZil ® custom pulse mode (mean±SD) Group 1† Group 2‡ p-value§ US§ time (sec) 125.7 ±49.2 96.3 ±58.2 0.01 US % 25.3 ± 2.2 27.5 ±5.4 0.14 CDE∏ (sec) 32.7 ±14.4 23.6 ±17.8 0.03 Aspiration time (sec) 313.9 ±123.6 245.6 ±131.6 Estimated fluid used (cc) 114.7 ±46.1 92.1 ±49.6 0.04 † Group 1= OZil ® continuous mode phacoemulsification ‡ Group 2= OZil ® custom pulse mode phacoemulsification § Mann-Whitney U-test ; § US=ultrasound ∏ CDE=cumulative dissipated energy = torsional amplitude x torsional timex0.4

Results Patients characteristics (mean±SD) Group 1† Group 2‡ p-value§ Eye(Patients) 25(24) 29(25) 0.36 Gender (male / female) 10 / 14 5 / 20 0.98 AGE (range) (years) 77.1±8.7 (60~97) 75.5±9.4(56~94) Mean nucleus density 5.3±0.5 Central corneal thickness(µm) 531.7±28.6 526.5±31.8 0.44 Endothelial cell count(cell/mm2 ) 2472±371 2514±302 0.78 Comparison of mean surgical parameters between OZil ® continuous mode and OZil ® custom pulse mode (mean±SD) Group 1† Group 2‡ p-value§ US§ time (sec) 125.7 ±49.2 96.3 ±58.2 0.01 US % 25.3 ± 2.2 27.5 ±5.4 0.14 CDE∏ (sec) 32.7 ±14.4 23.6 ±17.8 0.03 Aspiration time (sec) 313.9 ±123.6 245.6 ±131.6 Estimated fluid used (cc) 114.7 ±46.1 92.1 ±49.6 0.04 † Group 1= OZil ® continuous mode phacoemulsification ‡ Group 2= OZil ® custom pulse mode phacoemulsification § Mann-Whitney U-test ; § US=ultrasound ∏ CDE=cumulative dissipated energy = torsional amplitude x torsional timex0.4

Difference between preoperative and postoperative changes in central corneal thickness(CCT) (mean±SD) Pre-op Post-op 1day 3days 1week 2weeks 1month 2months 3months Group 1† µm/(∆* %) 531.7±28.6 596.4±78.2 (+12.0) 575.2±46.9 (+8.1) 564.3±49.1 (+6.0) 561.2±44.1 (+5.5) 541.3±34.1 (+1.8) 526.6±28.5 (-0.8) 525.2±29.2 (-1.1) Group 2‡ 526.5±31.8 565.7±39.1 (+7.5) 560.4±41.5 (+6.4) 548.8±39.6 (+4.2) 546.4±39.8 (+3.8) 534.6±38.5 (+1.5) 515.6±35.2 (-1.9) 517.0±34.5 (-1.6) P-value§ 0.44 0.26 0.28 0.16 0.20 0.65 0.39 0.84 † Group 1= OZil ® continuous mode phacoemulsification ‡ Group 2= OZil ® custom pulse mode phacoemulsification * Differences between pre-op and post-op changes in CCT; § Mann-Whitney U-test

Difference between preoperative and postoperative changes in endothelial cell count (mean±SD) Pre-op Post-op 1day 3days 1week 2weeks 1month 2months 3months Group 1† cell/mm2( ∆* %) 2472±371 1966±498 (-20.0) 1978±534 (-19.9) 2002±545 (-18.9) 2000±481 (-19.1) 2050±466 (-16.6) 2076±478 (-15.6) 2074±525 (-15.7) Group 2‡ 2514±302 2194±357 (-12.7) 2232±435 (-11.2) 2250±396 (-10.3) 2186±396 (-13.1) 2215±423 (-12.0) 2148±388 (-13.7) 2218±392 P-value§ 0.78 0.25 0.1 0.09 0.23 0.42 0.73 0.35 * * (cell/mm2) † Group 1= OZil ® continuous mode phacoemulsification; ‡ Group 2= OZil ® custom pulse mode phacoemulsification * Differences between pre-op and post-op changes in endothelial cell count § Mann-Whitney U-test

Difference between preoperative and postoperative changes in Descemet’s folds (mean±SD) Post-op 1day 3days 1week 2weeks 1month 2months 3months Group 1† 1.00±1.1 0.44±0.7 0.42±0.7 0.32±0.5 0.08±0.3 Group 2‡ 0.37±0.6 0.14±0.4 0.12±0.4 P-value§ 0.08 0.07 0.09 0.57 1.00 * * * * † Group 1= OZil ® continuous mode phacoemulsification; ‡ Group 2= OZil ® custom pulse mode phacoemulsification § Mann-Whitney U-test Descemet’s folds parameter : none (0), trace (1) , mild (2), moderate (3), severe (4)

Summary OZil ® custom pulse mode group exhibited significantly lower UST, aspiration time, estimated fluid used, and CDE. There were no significantly difference between the two groups in CCT increment, but OZil ® custom pulse mode group showed less CCT increase than OZil ® continuous mode group. OZil ® custom pulse mode group had significantly less endothelial cell count decline at 1 day and 1 week post-op. OZil ® custom pulse mode group had significantly lower corneal edema at 1 day ~ 2 weeks post-op. §

Conclusion In case of cataract surgeries involving hard nucleus(above NO5), the OZil® custom pulse mode used less ultrasound energy, and in turn reduced endothelial cell damage, leading to reduced corneal edema in early post-op period. Therefore, in surgery involving hard nucleus OZil® custom pulse mode is recommended to induce faster visual rehabilitation after surgery