Comparing surgical efficiencies between phacoemulsification systems: a single surgeon retrospective study of 2000 eyes
2022-04-19LuisEscafJarabaJorgeEscobarDiazGranadosBartolomValdemarn
INTRODUCTION
Age-related cataract is the most common cause of reversible blindness in the world
, with its first successful extraction of a cataract performed by Jacques Daviel in 1747
. In 1967, Charles Kelman
introduced phacoemulsification, a technique that uses ultrasonic waves to break down the cataract. Surgical extraction of the natural lens has progressed along time, leading to more than 20 million cataract surgeries performed worldwide each year
.Phacoemulsification is the gold standard for cataract surgeries globally and breakthroughs in different systems, ultrasound tips and sleeves continue to improve surgical efficiencies and results
.
Parameters for phacoemulsification for the active fluidics dynamic system were set as follows: IOP 65-70 mm Hg, vacuum 350-575-400 mm Hg, aspiration flow rate 38-52-41 mL/min and 20%-75% torsional amplitude. Fluid parameters for the gravitybased system were vacuum limit 100-450 mm Hg, aspiration flow rate 40 mL/min, bottle height 70-90 cm. Ultra sound parameters were set at 20%-80% of torsional amplitude.
Changes in aspiration and infusion flow rates can cause fluctuations in intraocular pressure (IOP)
. Wide fluctuations of IOP may cause the anterior chamber to collapse and damage the cornea, the iris, and the lens capsule
. Phacoemulsification systems such as active fluid dynamics and gravity-based fluidic, are used to perform cataract surgeries. Active fluid dynamics systems apply or release bag pressure in response to varying irrigation, to maintain a target IOP during surgery despite varying aspiration flow rates
. Maintaining anterior chamber stability and decreasing fluctuations in IOP is essential to reduce complications and improve postoperative outcomes
. A study conducted by de Giacinto
demonstrated a statistically significant transient increase in IOP during femtosecond laser-assisted cataract surgery. Even though IOP values decreased and came back to preoperative values at 1d postoperatively, sudden increases of IOP can be dangerous for the ocular structures
.
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The purpose of this study was to compare intraoperative surgical efficiency metrics between two phacoemulsification systems under similar conditions as previous studies comparing phacoemulsification systems failed at comparing surgical efficiencies using different parameters, phacoemulsification tip and sleeve. CDE and aspiration fluids were compared between an active fluidics dynamic system and a gravity-based fluidic system configured with the same ultrasound tip and sleeve.Surgery was performed by a single surgeon to 2000 eyes,during routine phacoemulsification extraction of cataracts graded with the Lens Opacities Classification System III(LOCS III).
SUBJECTS AND METHODS
This study was approved by the Institutional Ethics Committee of Research (Clínica Oftalmológica del Caribe, Barranquilla, Colombia) with code and number of approval CEFQX-01 and adhered to the Declaration of Helsinki's tenets.
This retrospective study of 2000 eyes was conducted in Barranquilla, Colombia from August 2017 to December 2019. A single surgeon operated all eyes and cataracts were graded using the LOCS III a standardized photographic comparison system for grading the features of the human age-related cataract
.
All consecutive cases of cataract extraction with phacoemulsification and intraocular lens (IOL) implantation were performed in a single ambulatory surgical center (Clínica Oftalmológica del Caribe, Barranquilla, Colombia). A total of 2000 eyes of adult patients who were diagnosed with a cataract were included in the study. The 1000 surgeries were performed using the Centurion Phacoemulsification System (active fluidics dynamic) and 1000 surgeries using the Infiniti Phacoemulsification System (gravity-based fluidic dynamics). All surgeries were performed by a single surgeon(Valdemarín B) and all patients were allocated randomly to each of the two systems depending on the operation room assigned. Both phacoemulsification systems were used to equal extent throughout the study period. The inclusion criteria were the following: patients diagnosed with cataract classified according to the LOCS III, corrected distance visual acuity (CDVA) inferior to 20/40 according to the Snellen Chart and individuals over 18 years of age. Patients were excluded from the study if they had a history of severe retinal disorders or detachment, clinically significant corneal endothelial dystrophy or history of corneal disease and ocular inflammatory conditions.
The study included 2000 eyes. Table 1 shows patient characteristics comparing both phacoemulsification systems.Phacoemulsification was performed in 1000 (50%) eyes with an active fluidics dynamic system and in 1000 (50%) eyes with a gravity-based fluidic system. Mean patient age was 69 years old for both systems. The 591 (59%) of patients operated with the active fluidics dynamic system and 554 (54%) of patients operated with the gravity-based fluidic system were female.Cataracts were graded with the LOCS III, 165 (16%) cataracts and 183 (18%) cataracts were graded between LOCS I and LOCS III in active fluidics dynamic system and gravity-based fluidic system, respectively. The majority of surgeries were performed on cataracts graded between LOCS IV and LOCS VI, 814 (81%) cataracts were operated using an active fluidics dynamic system and 789 (79%) cataracts were operated using a gravity-based fluidic system. White cataracts were classified as LOCS VII for analysis, 21 (2%) cataracts and 28(3%) cataracts were operated using an active fluidics dynamic system and gravity-based fluidic system, respectively.Table 2 shows a comparative analysis between phacoemulsification systems. Independent
-tests were performed to compare normally distributed variables. Mean CDE until fracture of the lens was 1.1 and 1.9 percent-seconds and total mean CDE used was 5.6 and 7.2 percent-seconds using an active fluidics dynamic system and gravity-based fluidic system, respectively(
<0.001). Both comparisons were calculated with a 95%confidence interval (CI). A reduction of 22% of CDE used was evidenced between phacoemulsification systems using the same tip and sleeve. Additionally, a reduction in the use of aspiration fluids was evidenced between phacoemulsification systems, mean fluids used were 70 and 84 mL using an active fluidics dynamic system and gravity-based fluidic system,respectively. A reduction of 16% of fluids used was evidenced using the active fluidics system (
<0.001).
Moreover, the rate of complications was 0.2% using the active fluidics system [1 posterior capsule rupture (PCR) and 1 zonular dialysis] and 0.9% using the gravity-based system (3 PCR, 5 zonular dialysis and 1 IOL change).
Cumulative dissipated energy (CDE) is the total ultrasound used during surgery to break down a cataract. CDE used during phacoemulsification is delivered by different ultrasound tips,that use longitudinal and torsional displacement to improve efficiencies, decreasing energy and fluids used
. Better outcomes in phacoemulsification surgeries are determined by the amount of ultrasound energy and fluids delivered to the eye
, lower ultrasound energy used during surgery results in less endothelial cell loss, less postoperative corneal edema and better immediate postoperative visual acuities
.
Both phacoemulsification systems used the same 0.9 mm 45-degree aspiration bypass system Intrepid Balanced tip and the 0.9 mm Intrepid Ultra infusion sleeve (Alcon Laboratories,2017).
CDE is displayed automatically on the Centurion (active fluidics dynamic system) and Infiniti(gravity-based system) interface and is measured in percentseconds. The CDE was calculated using the same formula for the active-fluidics system and the gravity-fluidics system(CDE=average energy amplitude times duty cycle times time in foot position 3). The amount of CDE used was measured when the lens was fractured entirely, and when all fragments had been removed. Aspiration fluids (mL/min) used were recorded from the display on each phacoemulsification system's user interface. All cataracts were graded using the LOCS III classification system. Additionally, grade VII in the LOCS III was included to classify white cataracts for statistical analysis.
Descriptive statistics were used to analyze patients' characteristics. Efficiency times were averaged, and Standard Deviation (SD). An independent
-test was performed to analyze normally distributed variables and detect statistically significant differences between phacoemulsification systems regarding CDE and aspiration fluids delivered. A scatter plot with a trend line comparing CDE used between Centurion
infiniti phacoemulsification system using the modified LOCS III classification system was performed.
values less than 0.05 were considered to be statistically significant. Statistical analysis was performed using the SPSS software (version 25;SPSS Inc., Chicago, IL, USA).
The estimated fluids used in the active-fluidic configuration were significantly lower compared to the gravity-fluidic systems (
<0.001). Reducing aspiration fluids during surgery may diminish heat production in the wound, minimizing unwanted corneal stromal changes, wound leaks and shifts in astigmatism
. Additionally, maintaining a safe and stable anterior chamber by controlling fluctuations in IOP may reduce instability or collapse, minimizing the risk of trauma to the cornea, the iris, or the lens capsule
. Transient increase in IOP is expected during surgery, hence, improving surgical efficiencies may help reduce unwanted damage to ocular structures
. A reduction of 16% of fluids used was evidenced using the active fluidics system when compared to the gravity fluidics system. Likewise, Gonzalez-Salinas
evidenced a decrease of 9.28% in aspiration fluids used between phacoemulsification systems by a single surgeon.
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RESULTS
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Figure 1 shows a scatter plot with a trend line comparing both phacoemulsification systems. The CDE used was compared between phacoemulsification systems and the cataract classification according to the modified LOCS III. Our findings evidenced that harder cataracts required higher amounts of CDE, as the nucleus is harder to emulsify. The trend line evidenced a more efficient use ultrasound and irrigation in the active fluidic system compared to the gravity-based system in all cataract classifications.
Surgery was performed according to site-specific standard operating procedures following the next steps: 1) Clear corneal incisions with MVR-Lance 20G at 40 degrees. 2) Application of intracameral Roxicain and Epinephrine 1%. 3) Injection of Trepan Blue for 30s.4) Injection of balanced salted solution and an ophthalmic viscosurgical device (OVD) sodium hyaluronate 1.4% (Bio-Hialur Plus). 5) Corneal incision of 2.75 mm at 140 degrees.6) Continuous curvilinear capsulorhexis of 5.0 to 5.5 mm with an Utrata forceps was created. 7) Hidrodissection and hidrodelamination until rotation of the lens was performed. 8)Both phacoemulsification systems used the 0.9 mm 45-degree aspiration bypass system Intrepid Balanced tip and the 0.9 mm Intrepid Ultra infusion sleeve (data on file, Alcon Laboratories,2017). 9) Phacoemulsification using vertical chop or horizontal chop was performed. 10) Aspiration of lens material and an OVD was applied to protect corneal endothelium:(hydroxypropylmethylcellulose 2%, Biocelulent). 11) Injection of the IOL provided by the institution. 12) Aspiration of the OVD and injection of intracameral antibiotic (moxifloxacin 0.5%). 13) Hydration of the incisions. 14) 10-0 nylon suture on main incision.
企业内控体系主要是对企业在经营中可能会发生的风险进行控制,这是其价值的重要体现。财务数据可以最直观地反映企业经营成果,它贯穿于企业的每一个工作部门,财务管理可以对各项财务指标与财务信息进行系统地分析,可以发现企业的财务风险,这正是企业内部控制所需要的。以往财务管理只对会计事项事中和事后进行管理,一些发生或者即将发生的财务风险就不能有效地解决和规避,在企业内控体系中的财务管理强调在会计事项事前就对可能产生的风险进行防范,在风险初期就能及时遏制,大力降低企业的经营风险,提升企业内部控制水平,保障企业资产的安全。
澳大利亚、加拿大等国在矿山治理和矿业绿色实践上有不少创新。澳大利亚实施生态可持续发展和生物多样性保护战略,制定了矿业可持续发展框架[10],并建立“矿山关闭基金”,要求矿山企业边开采、边恢复。同时还要求矿山企业缴纳土地复垦抵押金和年度环境报告,建立了监察员巡检制度 [11]。
DISCUSSION
Our study's main findings suggest that under similar conditions active fluidics phacoemulsification systems could improve surgical outcomes in cataract surgeries. Advances in technology and surgical techniques have improved surgical efficiencies by reducing energy dissipated at the incision site,fluids circulation through the anterior chamber and surgery time. There was a reduction of 22% in CDE using the active fluidics system when compared to the gravity-based fluidics system (
<0.001). These findings are consistent with Chen
's
and Solomon
's
studies, where a reduction of 40% and 38% in CDE between phacoemulsification systems was evidenced, respectively. Additionally, Lawrence
conducted a single surgeon, prospective study which evidenced a reduction of 13.5% in CDE used in phacoemulsification surgeries using the active fluidics dynamic system.
2.各组大鼠海马区组织中SOD和MDA水平比较:与假手术组比较,模型组大鼠SOD水平明显降低,MDA水平明显升高,差异有统计学意义(P<0.05);与模型组比较,有氧运动预处理组、HBO处理组、有氧运动+HBO处理组大鼠SOD水平明显升高,MDA含量明显降低,差异有统计学意义(P<0.05),且有氧运动+HBO处理组效果最明显(P<0.01)。见表2。
阅读前的调查显示青少年会花精力去查找他们要读什么。主要有三方面行为的调查:目标锁定行为的调查结果显示,大部分青少年都有自己非常喜欢的书籍类型,已经形成自己的阅读内容偏好,并将这种偏好作为自己锁定阅读目标的重要考虑因素;阅读决策行为的调查结果显示,65%的被调查者认为参考他人、查找评论、试读、书籍比较是其普遍选择,同时,查找网络评价、网上试读两个选项的调查结果差异较大;书籍获取行为的调查结果显示,68%的被调查者使用手机、iPad等移动设备进行阅读,65%的被调查者通过搜索引擎查找想读的书籍。
Hayashi
identified more complicated cataracts and significant infusion volumes as substantial risk factors for endothelial cell loss. Additionally, Pirazolli
evidenced that the phaco-chop technique requires lower CDE and aspiration fluids to break down a cataract; therefore, it may reduce endothelial cell damage. Consequently, increasing the safety of phacoemulsification surgeries by reducing CDE and aspiration fluids, may improve surgical results and patients postoperative visual acuities
.
Adequate cataract classification should contribute to more predictable and effective cataract surgeries, as dense cataracts require more energy to emulsify
. Although, the relationship between phacoemulsification energy expenditure and cataract classification may vary between surgeons, technique and equipment used
. While the active fluidics dynamic phacoemulsification system demonstrated better surgical efficiencies than the gravity-based fluidics system, both systems' rate of complications is low. Different studies have shown no statistically significant differences between the intraoperative complication rate of phacoemulsification systems, as both types of equipment deliver a relatively safe surgical procedure, varying between patients and surgeon
.
This study compared cataract surgeries performed with two phacoemulsification systems under similar conditions which may contribute to better understanding of phacoemulsification surgical parameters. A particular strength of this study is the large number of cases included, performing surgeries using similar ultrasound settings, and surgical techniques with the same phacoemulsification tip and sleeve. These findings were consistent suggesting that the results may be broadly applicable. Nonetheless, this study has some limitations. To identify better surgical results between phacoemulsification system, a prospective study is required to compare postoperative visual acuities, postoperative changes in central corneal thickness and endothelial cell density. These findings are needed to understand further the clinical relevance for preforming cataract surgeries using an active fluidics phacoemulsification system.
In conclusion, surgeries performed under similar conditions(same surgeon, phaco tip and sleeve) with the active fluidics dynamic system required significantly lower CDE and aspiration fluids than the gravity fluidics system. Cataract blindness has a significant impact on the socio-economic development of individuals and societies
; therefore, better surgical outcomes are sought to improve postoperative results.
None;
None;
None.
1 WHO. Global data on visual impairments 2010. World Health Organization http://www.whoint/blindness/GLOBALDATAFINAL.
2 Kelman CD, Kwitko ML.
.Hague, Netherlands: Kugler Publications; 1998.
3 Jensen JD, Shi DS, Robinson MS, Kramer GD, Zaugg B, Stagg BC,Pettey JH, Barlow WR Jr, Olson RJ. Torsional power study using CENTURION phacoemulsification technology.
2016;44(8):710-713.
4 Salman S, Mourad M, ElGhazawy R, Rihan R. Comparative study of conventional versus torsional phacoemulsification in management of hard nucleus.
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2016;42(1):157-162.
8 de Giacinto C, D'Aloisio R, Bova A, Candian T, Perrotta AA, Tognetto D. Intraocular pressure changes during femtosecond laser-assisted cataract surgery: a comparison between two different patient interfaces.
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9 Chylack LT Jr, Wolfe JK, Singer DM, Leske MC, Bullimore MA, Bailey IL, Friend J, McCarthy D, Wu SY. The lens opacities classification system III. the longitudinal study of cataract study group.
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11 Lawrence JO, Chu Luan N, Eugene W, Samuel SYW, Ian CF.Prospective study of Centurion
versus Infiniti
phacoemulsification systems: surgical and visual outcomes.
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12 Gonzalez-Salinas R, Garza-Leon M, Saenz-de-Viteri M, Solis-S JC,Gulias-Cañizo R, Quiroz-Mercado H. Comparison of cumulative dissipated energy delivered by active-fluidic pressure control phacoemulsification system versus gravity-fluidics.
2018;38(5):1907-1913.
13 Hayashi K, Hayashi H, Nakao F, Hayashi F. Risk factors for corneal endothelial injury during phacoemulsification.
1996;22(8):1079-1084.
14 Pirazzoli G, D'Eliseo D, Ziosi M, Acciarri R. Effects of phacoemulsification time on the corneal endothelium using phacofracture and phaco chop techniques.
1996;22(7):967-969.
15 Davison JA, Chylack LT. Clinical application of the lens opacities classification system III in the performance of phacoemulsification.
2003;29(1):138-145.
16 Kaur M, Bhai N, Titiyal JS. Risk factors for complications during phacoemulsification cataract surgery.
2020;15(5):303-312.
17 Gupta M, Ram J, Jain A, Sukhija J, Chaudhary M. Correlation of nuclear density using the Lens Opacity Classification System III versus Scheimpflug imaging with phacoemulsification parameters.
2013;39(12):1818-1823.
18 Wan Y, Wang YH, Zhao LM,
. The association between socioeconomic factors and visual function among patients with agerelated cataracts.
2020;2020:7236214.
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