Subject(s)
Cross-Cultural Comparison , Ethics, Medical , General Surgery/ethics , Patient Selection/ethics , Triage/ethics , Decision Making/ethics , Developed Countries , Developing Countries , General Surgery/methods , Health Status Disparities , Healthcare Disparities , Humans , International Cooperation , Medically Underserved Area , Ophthalmologic Surgical Procedures/ethics , Ophthalmologic Surgical Procedures/methods , Risk Assessment , Standard of Care/ethics , Triage/methods , VolunteersABSTRACT
PURPOSE: To compare the postoperative outcomes of cataract surgery performed with the Sovereign 4.0 system or the Sovereign system with WhiteStar power modulation. SETTING: Ambulatory surgery centers at 4 sites in the United States. METHODS: This was a 3-month, open-label, randomized, parallel-group comparative clinical trial in patients with visually interfering cataract. Surgeons used the divide-and-conquer phacoemulsification technique for nuclear removal. An intraocular lens was implanted using the recommended insertion system. Primary operative outcome measures were equivalent phaco time (EPT), percentage of phaco power, amount of balanced salt solution used, and surgical complications. Patients were seen 1 day and 3 months after surgery. Postoperative outcome measures were the change in endothelial cell count from the preoperative visit to 3 months, corneal clarity, inflammation, and corneal thickness. RESULTS: The Sovereign with WhiteStar group had 48 patients and the Sovereign 4.0 group, 49 patients. Mean EPT and mean percentage of power were significantly lower in the Sovereign with WhiteStar group. Mean EPT was 6.67 seconds +/- 8.2 (SD) in the Sovereign with WhiteStar group and 8.59 +/- 9.3 seconds (P = .01) in the Sovereign 4.0 group. Mean percentage of phaco power was 6.41% +/- 3.3% in the Sovereign with WhiteStar group and 8.51% +/- 4.9% in the Sovereign 4.0 group (P = .01). The Sovereign with WhiteStar group lost significantly fewer endothelial cells (-319.6 +/- 634.2 cells/mm(2)) than the Sovereign 4.0 group (-430.3 +/- 594.6 cells/mm(2)) (P = .01). Corneal clarity, cells and flare, and pachymetry were comparable with the exception of the 3-month visit. The mean change in baseline central pachymetry showed significantly less corneal thickening in the Sovereign with WhiteStar group. CONCLUSIONS: The Sovereign with WhiteStar power modulation system provides effective lens removal at lower levels of phaco power and ultrasound energy than the Sovereign 4.0 system. Lower ultrasound levels may reduce the risk for endothelial cell loss during phacoemulsification.
Subject(s)
Phacoemulsification/methods , Cell Count , Endothelium, Corneal/pathology , Humans , Intraoperative Complications , Lens Implantation, Intraocular , Phacoemulsification/instrumentation , Postoperative Complications , Treatment OutcomeABSTRACT
PURPOSE: To assess intraoperative thermal levels at the wound site during divide-and-conquer phacoemulsification with the Sovereign with WhiteStar (SWS) system or the Legacy with AdvanTec and NeoSoniX (LAD) system. DESIGN: Prospective, randomized, parallel-group, comparative study. METHODS: Twenty-six subjects from a private clinical practice underwent divide-and-conquer phacoemulsification with either the SWS system or the LAD system. CB/CF settings (60%/33% duty cycles) were utilized with SWS and 12 pulses per second with the LAD system. Key criteria assessed were peak wound-site temperature, mean temperature change at the wound site, effective phaco time, average phaco power, procedure time, amount of BSS used, and surgical complications. RESULTS: Mean temperature change at the wound site was greater for the LAD than the SWS group. There was a statistically significant difference (P=.0002) in mean peak wound temperatures, with the LAD group having higher mean peak temperatures (42.47+/-5.33 degrees C) than the SWS group (36.59+/-1.33 degrees C). Highest wound-site temperature was 51 degrees C for the LAD group and 39.3 degrees C for the SWS group. A statistically significant difference (P=.0031) in mean peak temperature was found between the LAD and SWS systems for subjects with a cataract density of 4: higher mean peak temperatures were observed for LAD patients with a cataract density of 4. CONCLUSIONS: Our findings show that phacoemulsification using the SWS system results in lower peak temperatures and less temperature change at the phaco wound site compared with the LAD system.
