Kerry D Solomon1, Ramón Lorente2, Doug Fanney2, Robert J Cionni2. 1. From the Carolina Eyecare Physicians (Solomon), Charleston, South Carolina, Alcon Research, Ltd. (Fanney), Irvine, California, and the Eye Institute of Utah (Cionni), Salt Lake City, Utah, USA; Complejo Hospitalario Universitario Orense (Lorente), Orense, Spain. Electronic address: kerry.solomon@carolinaeyecare.com. 2. From the Carolina Eyecare Physicians (Solomon), Charleston, South Carolina, Alcon Research, Ltd. (Fanney), Irvine, California, and the Eye Institute of Utah (Cionni), Salt Lake City, Utah, USA; Complejo Hospitalario Universitario Orense (Lorente), Orense, Spain.
Abstract
PURPOSE: To compare cumulative dissipated energy (CDE), aspiration fluid used, and aspiration time during phacoemulsification cataract extraction using 2 surgical configurations. SETTING: Two clinical sites in the United States and 1 in Spain. DESIGN: Prospective randomized clinical case series. METHODS: For each patient, the first eye having surgery was randomized to the active-fluidics configuration (Centurion Vision System with Active Fluidics, 0.9 mm 45-degree Intrepid Balanced tip, and 0.9 mm Intrepid Ultra infusion sleeve) or the gravity-fluidics configuration (Infiniti Vision System with gravity fluidics, 0.9 mm 45-degree Mini-Flared Kelman tip, and 0.9 mm Ultra infusion sleeve). Second-eye surgery was completed within 14 days after first-eye surgery using the alternate configuration. The CDE, aspiration fluid used, and aspiration time were compared between configurations, and adverse events were summarized. RESULTS: Patient demographics and cataract characteristics were similar between configurations (100 per group). The CDE was significantly lower with the active-fluidics configuration than with the gravity-fluidics configuration (mean ± standard error, 4.32 ± 0.28 percent-seconds) (P < .001). The active-fluidics configuration used significantly less aspiration fluid than the gravity-fluidics configuration (mean 46.56 ± 1.39 mL versus 52.68 ± 1.40 mL) (P < .001) and required significantly shorter aspiration time (mean 151.9 ± 4.1 seconds versus 167.6 ± 4.1 seconds) (P < .001). No serious ocular adverse events related to the study devices or device deficiencies were observed. CONCLUSION: Significantly less CDE, aspiration fluid used, and aspiration time were observed with the active-fluidics configuration than with the gravity-fluidics configuration, showing improved surgical efficiency. FINANCIAL DISCLOSURES: Drs. Solomon and Cionni are consultants to Alcon Research, Ltd., and received compensation for conduct of the study. Dr. Lorente received compensation for clinical work in the study. Mr. Fanney is an employee of Alcon Research, Ltd.
RCT Entities:
PURPOSE: To compare cumulative dissipated energy (CDE), aspiration fluid used, and aspiration time during phacoemulsification cataract extraction using 2 surgical configurations. SETTING: Two clinical sites in the United States and 1 in Spain. DESIGN: Prospective randomized clinical case series. METHODS: For each patient, the first eye having surgery was randomized to the active-fluidics configuration (Centurion Vision System with Active Fluidics, 0.9 mm 45-degree Intrepid Balanced tip, and 0.9 mm Intrepid Ultra infusion sleeve) or the gravity-fluidics configuration (Infiniti Vision System with gravity fluidics, 0.9 mm 45-degree Mini-Flared Kelman tip, and 0.9 mm Ultra infusion sleeve). Second-eye surgery was completed within 14 days after first-eye surgery using the alternate configuration. The CDE, aspiration fluid used, and aspiration time were compared between configurations, and adverse events were summarized. RESULTS:Patient demographics and cataract characteristics were similar between configurations (100 per group). The CDE was significantly lower with the active-fluidics configuration than with the gravity-fluidics configuration (mean ± standard error, 4.32 ± 0.28 percent-seconds) (P < .001). The active-fluidics configuration used significantly less aspiration fluid than the gravity-fluidics configuration (mean 46.56 ± 1.39 mL versus 52.68 ± 1.40 mL) (P < .001) and required significantly shorter aspiration time (mean 151.9 ± 4.1 seconds versus 167.6 ± 4.1 seconds) (P < .001). No serious ocular adverse events related to the study devices or device deficiencies were observed. CONCLUSION: Significantly less CDE, aspiration fluid used, and aspiration time were observed with the active-fluidics configuration than with the gravity-fluidics configuration, showing improved surgical efficiency. FINANCIAL DISCLOSURES: Drs. Solomon and Cionni are consultants to Alcon Research, Ltd., and received compensation for conduct of the study. Dr. Lorente received compensation for clinical work in the study. Mr. Fanney is an employee of Alcon Research, Ltd.
Authors: Roberto Gonzalez-Salinas; Manuel Garza-Leon; Manuel Saenz-de-Viteri; Juan C Solis-S; Rosario Gulias-Cañizo; Hugo Quiroz-Mercado Journal: Int Ophthalmol Date: 2017-08-22 Impact factor: 2.031
Authors: Wilson Takashi Hida; Patrick Frenzel Tzelikis; César Vilar; Mario Augusto Pereira Dias Chaves; Antônio Francisco Pimenta Motta; Pedro Carlos Carricondo; Bruna Vieira Ventura; Renato Ambrosio; Walton Nosé; Milton Ruiz Alves Journal: Clin Ophthalmol Date: 2017-09-25