Safety of cataract surgery in patients treated with the new oral anticoagulants (NOACs).

PURPOSE: To evaluate the safety of phacoemulsification of cataract in patients taking new oral anticoagulants (NOACs). METHODS: In a prospective case series, consecutive patients on NOACs (dabigatran, rivaroxaban, or apixaban) who were referred for uncomplicated cataract surgery to the eye institute underwent a thorough ophthalmological and hematological evaluation. Rivaroxaban and apixaban anti-factor Xa tests, and diluted thrombin time for dabigatran, were used for monitoring anticoagulation levels in blood. Blood was drawn for these tests just prior to surgery and at a peak level of the drug at about 4 h post-surgery (2 h after the drug was given). All surgeries were videotaped and patients were examined at 1 and 7 days after the operation. The main outcome measures included assessment of intra-operative, postoperative ocular bleeding, and other related complications. RESULTS: Thirty-five eyes of 25 unrelated patients ranging in age from 63 to 92 years (mean 77.6 years) underwent phacoemulsification. Intra-operative bleeding was observed in 5 eyes from the conjunctiva or limbus at the main incision site. No intraocular bleeding occurred. No hemorrhagic complications were observed during the 1-week follow-up. According to anti-factor Xa levels prior to surgery and following surgery, 85% of the patients were on therapeutic levels of NOACs. CONCLUSIONS: Clear corneal incision phacoemulsification performed under topical anesthesia can be safely performed in simple cases of cataract without discontinuing NOAC treatment.

How close are we? An audit of biometry of a tertiary care hospital in Karachi.

OBJECTIVE: To evaluate the accuracy of biometry in the post-op phase of cataract surgery. METHODS: This study was conducted at Liaquat National Hospital, Karachi, from June 2015 to July 2016, and comprised the audit of patients who underwent cataract surgery during the period. Keratometry was done on Haag-Strait manual keratometer and A-scan was done by applanation contact method on SonoMed machine. Theoretic-T formula was used to calculate desired intraocular lens power for all kinds of axial lengths. A single surgeon operated upon the same Alcon Constellation phacoemulsification machine. Postoperative follow-up was done by monitoring auto refraction and visual acuity on days 1, 7, 30 and 90. SPSS 21 was used for data analysis.. RESULTS: Of 244 patients, 121(49.60%) were males and 123(50.40%) were females. There were 123(50.40%) right eyes and 121(49.60%) left eyes. Overall, 132(54.10%) achieved postoperative refraction within ±0.5 D of target and 193(79.10%) within ±1 D of target. Age, gender and laterality had no significant effect on outcomes (p>0.05 each). CONCLUSIONS: Postoperative refraction corresponded quite closely with global recommendations.

Office-Based Cataract Surgery: Population Health Outcomes Study of More than 21 000 Cases in the United States.

PURPOSE: To identify safety and effectiveness outcomes of office-based cataract surgery. Each year, approximately 3.7 million cataract surgeries in the United States are performed in Ambulatory Surgery Center (ASC) and Hospital Outpatient Department (HOPD) locations. Medicare in July 2015 published a solicitation for expert opinion on reimbursing office-based cataract surgery. DESIGN: Large-scale, retrospective, consecutive case series of cataract surgeries performed in Minor Procedure Rooms (MPRs) of a large US integrated healthcare center. PARTICIPANTS: More than 13 500 patients undergoing elective office-based cataract surgery. METHODS: Phacoemulsification cataract surgery performed in MPRs of Kaiser Permanente Colorado from 2011 to 2014. MAIN OUTCOME MEASURES: Postoperative visual acuity and intraoperative and postoperative adverse events (AEs). RESULTS: Office-based cataract surgery was completed in 21 501 eyes (13 507 patients, age 72.6±9.6 years). Phacoemulsification was performed in 99.9% of cases, and manual extracapsular extraction was performed in 0.1% of cases. Systemic comorbidities included hypertension (53.5%), diabetes (22.3%), and chronic obstructive pulmonary disease (9.4%). Postoperative mean best-corrected visual acuity measured 0.14±0.26 logarithm of the minimum angle of resolution units. Intraoperative ocular AEs included 119 (0.55%) cases of capsular tear and 73 (0.34%) cases of vitreous loss. Postoperative AEs included iritis (n = 330, 1.53%), corneal edema (n = 110, 0.53%), and retinal tear or detachment (n = 30, 0.14%). No endophthalmitis was reported. Second surgeries were performed in 0.70% of treated eyes within 6 months. There were no life- or vision-threatening intraoperative or perioperative AEs. CONCLUSIONS: This is the largest US study to investigate the safety and effectiveness of office-based cataract surgery performed in MPRs. Office-based efficacy outcomes were consistently excellent, with a safety profile expected of minimally invasive cataract procedures performed in ASCs and HOPDs.

Outpatient cataract surgery: incident and procedural risk analysis do not support current clinical ophthalmology guidelines.

OBJECTIVE: To evaluate whether an ophthalmologist-led, non-anesthesia-supported, limited monitoring pathway for phacoemulsification/intraocular lens cataract surgery, can be performed safely with only a medical emergency team providing support. DESIGN: Retrospective, observational, cohort study. PARTICIPANTS: All patients who underwent elective phacoemulsification/intraocular lens surgery under topical anesthesia in the ophthalmology outpatient unit between January 1, 2011, and December 31, 2012. METHODS: Cataract surgery was performed by phacoemulsification under topical anesthesia. The intake process mainly embraced ophthalmic evaluation, obtaining a medical history, and proposing the procedure. A staff ophthalmologist performed the procedure assisted by 2 registered nurses in an independent outpatient clinic operating room within the hospital. The clinical pathway was without dedicated presence of or access to anesthesia service. Perioperative monitoring was limited to blood pressure and plethysmography preoperatively and intraoperatively. Patients were offered supportive care and instructed to avoid fasting and continue all their chronic medication. MAIN OUTCOME MEASURES: The primary outcome measure was the incidence of adverse events requiring medical emergency team (MET) interventions throughout the pathway. Secondary outcome measures were surgical ocular complication rates, use of oral sedatives, and reported reasons to perform the surgery in the classical operation room complex. RESULTS: Within the cataract pathway, 6961 cases (4347 patients) were eligible for analysis. Three MET interventions related to the phacoemulsification/intraocular lens pathway occurred in the 2-year study period, resulting in an intervention rate of 0.04%. None of the interventions was intraoperative. All 3 patients were diagnosed as vasovagal collapse and recuperated uneventfully. No hospital admittance was required. Eight other incidents occurred within the general ophthalmology outpatient unit population during the study period. CONCLUSIONS: Cataract surgery can be safely performed in an outpatient clinic, in the absence of the anesthesia service and with limited workup and monitoring. Basic first aid and basic life support skills seem to be sufficient in case of an adverse event. An MET provides a generous failsafe for this low-risk procedure.

Cataract surgery audit at an Australian urban teaching hospital.

BACKGROUND: To provide local data on visual acuity and surgical outcomes for cataract surgery performed in an Australian teaching hospital. DESIGN: Continuous audit over 7 years in a public teaching hospital. PARTICIPANTS: A total of 3740 eyes had cataract surgery performed at The Queen Elizabeth Hospital, South Australia, from May 2006 to September 2013. METHODS: Visual acuity and complication rates were recorded for cataract surgery cases operated on between May 2006 and September 2013 on a digital database with data entry contemporaneous with final follow-up. MAIN OUTCOME MEASURES: Visual acuity and surgical complications. RESULTS: Of the patients, 91.4% achieved postoperative best-measured vision better than preoperative best-measured vision. The rate of posterior capsular tear was 2.59%, endophthalmitis was 0.11% and the overall complication rate was 11.7%. CONCLUSIONS: This audit is the first to document modern cataract surgery, overwhelmingly dominated by phacoemulsification in an Australian population and can be used to benchmark cataract surgery outcome in an urban Australian population.

Phacoemulsification versus peripheral iridotomy in the management of chronic primary angle closure: long-term follow-up.

Primary angle closure occurs as a result of crowded anterior segment anatomy, causing appositional contact between the peripheral iris and trabecular meshwork, thereby obstructing aqueous outflow. Several studies highlight the role of the crystalline lens in its pathogenesis. The objective of this work is to compare the long-term efficacy of phacoemulsification versus laser peripheral iridotomy (LPI) in the management of chronic primary angle closure (CPAC). Prospective case-control study with 30 eyes of 30 patients randomly divided in two groups: 15 eyes in the LPI group and 15 eyes in the IOL group. Patients in the LPI group underwent LPI using argon and Nd:YAG laser. Patients in the IOL group underwent phacoemulsification with posterior chamber intraocular lens (IOL) implantation. Examinations before and after the procedure included gonioscopy, Goldmann applanation tonometry, and anterior chamber evaluation using the Pentacam rotating Scheimpflug camera. The mean follow-up time was 31.13 ± 4.97 months. There was a statistically significant reduction in the intraocular pressure (IOP) and number of anti-glaucoma medications (p < 0.01) only in the IOL group. Anterior chamber depth, angle, and volume were all higher in the IOL group (p < 0.01) at the end of the follow-up period. Phacoemulsification with posterior chamber IOL implantation results in a higher anterior chamber depth, angle, and volume, when compared to LPI. Consequently, phacoemulsification has greater efficacy in lowering IOP and preventing its long-term increase in patients with CPAC and cataract.

Phaco-efficiency test and re-aspiration analysis of repulsed particle in phacoemulsification.

BACKGROUND: To measure the efficiency of phacoemulsification, we have developed a new experimental model for testing phaco-efficiency and analyzed re-aspiration of repulsed particles. METHODS: Using a Kitaro wetlab system, a piece of blood agar (BA) was placed in an artificial chamber and the phacoemulsifier was placed horizontally. The settings of the phacoemulsifier (Infiniti, Alcon Laboratories) were 26 cc/min for aspiration, 350 cc/min for vacuum, and 95 cm of bottle height. The time to remove BAs was measured using Ozil 100 %, Ozil 40 %, and longitudinal 40 % of phaco power. The angle between the re-aspirated BA particles and the axis of the phacoemulsifier (re-aspiration zone, degree) was analyzed. RESULTS: The average time (seconds) to remove BAs was lower in the Ozil 100 % and the Ozil 40 % mode than in the longitudinal mode (0.37 ± 0.39, 0.85 ± 0.57, and 2.22 ± 1.40 respectively, P value < 0.01). Repulsion exceeding 1 mm occurred more frequently in the longitudinal mode than in the Ozil 100 % mode (100 % vs 40 %, P value = 0.01, Fisher's exact test). The average of re-aspiration zone was 25.9 ± 14.5 in the longitudinal 40 % and 54.0 ± 23.0 in the Ozil 40 % (P value = 0.016). CONCLUSIONS: The Ozil mode was more efficient than the longitudinal mode. In addition, the Ozil mode provided less repulsion and wider aspiration zone.

Long-term outcomes of phacoemulsification cataract surgery performed by trainees and consultants in an Australian cohort.

BACKGROUND: It is unclear whether differences exist in surgical complication rates and long-term visual acuity outcomes between patients whose phacoemulsification cataract surgery was performed by ophthalmological trainees and those performed by consultants. DESIGN: Prospective clinical cohort study. PARTICIPANTS: 1851 participants of the Cataract Surgery and Age-related Macular Degeneration study, aged ≥64 years, had cataract surgery performed at Westmead Hospital, Sydney. METHODS: Surgical complication rates and visual acuity at 24-month postoperative visits were compared between patients who were operated on by trainees and those operated on by consultants. MAIN OUTCOME MEASURES: Surgical outcomes included operative complications recorded in surgical audit forms and 24-month postoperative visual acuity. RESULTS: Of 1851 patients, 1274 (68.8%) were reviewed 24 months after surgery. Of these, 976 had data on the type of surgeon who performed the operation. After excluding 152 challenging cases and three cases operated on by first-year trainees at the beginning of their training, 821 patients were included in this study, of those, 498 were operated on by trainees and 323 by consultants. Habitual visual acuity ≥6/12 was achieved in 77.3% (n = 385/498) and 74.3% (n = 240/323), respectively, of the two groups of patients 24 months postoperatively. Of 514 patients who had surgical audit data, the major complication rate was numerically greater, but not significantly different for the 330 trainee-operated (6.1%) patients, compared with the 184 consultant-operated patients (2.7%, P = 0.091). CONCLUSIONS: We found relatively comparable complication rates and visual outcomes after 2 years between patients operated on by ophthalmological trainees and those by consultants, in a cataract surgical cohort at Westmead Hospital.

Corneal wound architecture and integrity after torsional and mixed phacoemulsification: evaluation of standard and microincisional coaxial techniques.

BACKGROUND AND OBJECTIVE: To compare the effects of torsional and mixed ultrasound on clear corneal incision architecture, wound integrity, and apposition using standard (2.75 mm) and microincisional (2.2 mm) coaxial phacoemulsification. SUBJECTS AND METHODS: Twenty human cadaver eyes (4 groups of 5 eyes) underwent simulated coaxial phacoemulsification for 45 seconds of ultrasound time (group 1 = 2.75 mm, 100% torsional; group 2 = 2.2 mm, 70% torsional; group 3 = 2.2 mm, 100% torsional; group 4 = 2.2 mm, mixed ultrasound). All phacoemulsification settings were kept constant across each group. Following phacoemulsification, intraocular pressure (IOP) was cyclically raised and lowered from 0 to 125 mm Hg. Two eyes from each group had India ink placed over the wound and were observed for leakage and for histopathologic examination. Eyes not exposed to India ink (three eyes of each group) were examined using anterior segment optical coherence tomography (OCT) and scanning electron microscopy (SEM). RESULTS: Wound leakage was evident in one eye from group 1 and no eyes from the other three groups. Histopathologic examination revealed no India ink penetration in any of the eyes studied. Anterior segment OCT showed good wound apposition in each group. SEM demonstrated partially compromised endothelium and Descemet's membrane in all eyes studied from each group. CONCLUSION: No differences in corneal wound architecture and integrity were observed. Torsional and mixed ultrasound settings do not appear to induce any adverse effects on corneal wound architecture and integrity in standard and microincisional coaxial phacoemulsification techniques.

Risk factors for dropped nucleus in cataract surgery as reflected by the European Registry of Quality Outcomes for Cataract and Refractive Surgery.

PURPOSE: To analyze the incidence, risk factors, and outcomes of cataract surgery complicated by a dropped nucleus. SETTING: Patients who have received cataract surgery in 18 European countries. DESIGN: Retrospective cross-sectional register-based study. METHODS: Data from the European Registry of Quality Outcomes for Cataract and Refractive Surgery (EUREQUO) were analyzed. The EUREQUO contains preoperative baseline, intraoperative, and follow-up data. Intraoperative data include dropped nucleus as a complication. Baseline data such as demographic data, ocular comorbidities, surgical difficulties, and visual and refractive outcomes were tested for association with a dropped nucleus for the study period from January 1, 2008, to December 31, 2018. RESULTS: The number of reported patients with complete data was 1 715 348. Dropped nucleus was reported in 1221 eyes (0.071%) during the study period. White cataract, previous vitrectomy, poor preoperative visual acuity, small pupil, pseudoexfoliation, diabetic retinopathy, and male sex were significantly related to dropped nucleus. Year of surgery showed a significant trend of decreasing occurrence of dropped nucleus over time. Eyes with the complication of a dropped nucleus also had a poorer visual and refractive outcome compared with eyes with existing risk factors but no such complication. CONCLUSIONS: Many risk factors for dropped nucleus complications were identified. A significant trend of decreasing occurrence of dropped nucleus was found for the study period. The visual and refractive outcome was poorer for eyes with a dropped nucleus.

Quantification of intraocular surgery motions with an electromagnetic tracking system.

Motion tracking was performed during a combined phacoemulsification (PKE) and pars plana vitrectomy (PPV) procedure on a pig eyeball. The UCLA Laparoscopic Training System (UCLA-LTS), which consists of electromagnetic sensors attached to the surgical tools to measure three-dimensional spatial vectors, was modified to enable quantification of intraocular surgery motions. The range of motion and time taken to complete the given task were successfully recorded.

Human Reliability Analysis of Cataract Surgery.

OBJECTIVE: To evaluate the use of the Human Reliability Analysis of Cataract Surgery tool to identify the frequency and pattern of technical errors observed during phacoemulsification cataract extraction by surgeons with varying levels of experience. DESIGN: Observational cohort study. Thirty-three consecutive phacoemulsification cataract operations were performed by 33 different ophthalmic surgeons with varying levels of operative experience: group 1, fewer than 50 procedures; group 2, between 50 and 250 procedures; and group 3, more than 250 procedures. Face and content validity were surveyed by a panel of senior cataract surgeons. The tool was applied to the 33 randomized and anonymous videos by 2 independent assessors trained in error identification and correct tool use. Task analysis using 10 well-defined end points and error identification using 10 external error modes were performed for each case. The main outcome measures were number of errors performed per task, nature of performed errors (executional or procedural), and surgical experience of operating surgeon. RESULTS: Analysis of 330 constituent steps of 33 operations identified 228 errors, of which 151 (66.2%) were executional and 77 (33.8%) were procedural. The overall highest error probability was associated with sculpting, followed by fragmentation of the nucleus; this was most evident in group 1. Surgeons in group 3 proportionally performed more errors during removal of soft lens matter than those in group 1 or 2. Surgical experience had a significant effect on the number of errors, with a statistically significant difference among the 3 groups (P < .001). CONCLUSIONS: The Human Reliability Analysis of Cataract Surgery tool is useful for identifying where technical errors occur during phacoemulsification cataract surgery. The study findings, including the high executional error rate, could be used to enhance and structure resident surgical training and future assessment tools. Face, content, and construct validity of the tool were demonstrated.

Comparison of the Infiniti vision and the series 20,000 Legacy systems.

PURPOSE: To compare the efficiency of the Infiniti vision system and the Series 20,000 Legacy system phacoemulsification units during routine cataract extraction. METHODS: Thirty-nine eyes of 39 patients were randomized to have their cataract removed using either the Infiniti or the Legacy system, both using the Neosonix handpiece. System settings were standardized. Ultrasound time, amount of balanced salt solution (BSS) used intraoperatively, and postoperative visual acuity at postoperative days 1, 7 and 30 were evaluated. RESULTS: Preoperatively, best corrected visual acuity was significantly worse in the Infiniti group compared to the Legacy group (0.38 +/- 0.23 and 0.21 +/- 0.16, respectively; p = 0.012). The mean phacoemulsification time was 39.6 +/- 22.9 s (range 6.0-102.0) for the Legacy group and 18.3 +/-19.1 s (range 1.0-80.0) for the Infiniti group (p = 0.001). The mean amounts of intraoperative BSS used were 117 +/- 37.7 ml (range 70-195) in the Legacy group and 85.3 +/- 38.9 ml (range 40-200) in the Infiniti group (p = 0.005). No differences in postoperative visual acuity were found. CONCLUSION: The ability to use higher flow rates and vacuum settings with the Infiniti vision system allowed for cataract removal with less phacoemulsification time than when using the Legacy system.

Bimanual microincision phacoemulsification in treating hard cataracts using different power modes.

PURPOSE: To compare the performance of the Multiburst mode, the Shortpulse mode and the Whitestar technology of the Sovereign platform in treating hard cataracts with bimanual microincision phacoemulsification. METHODS: 101 eyes with hard cataracts (nuclear density Grade 3 and Grade 4 or above) were randomized into three groups. Bimanual microincision phacoemulsification was performed using the Multiburst mode, the Shortpulse mode and the Whitestar technology of the Sovereign phacoemulsification machine respectively. The average power, total duration of ultrasonic power release (US Time), effective phaco time, complications, best-corrected visual acuity and rate of corneal endothelial cell loss were measured and compared among the study groups. RESULTS: For hard cataracts of various nuclear densities, average ultrasonic power was highest in the Whitestar group followed by the Shortpulse group. The Multiburst group had the highest US Time, effective phaco time and rate of corneal endothelial cell loss whereas the Whitestar Group had the lowest.The differences between the groups were found to be statistically significant by variation analysis and the Fisher's least significant difference procedure. However, there were no significant differences between the USTime values of the Shortpulse Group and the Whitestar Group (P = 0.051). In the Multiburst Group, wound burn occurred in one eye, and three eyes had abnormal fluctuations in the anterior chamber depth. CONCLUSIONS: The Whitestar technology showed the best performance in this study.The Multiburst mode was proved to be a relatively unsuitable ultrasonic power mode in treating hard cataracts with bimanual microincision phacoemulsification.

Raising the benchmark for the 21st century--the 1000 cataract operations audit and survey: outcomes, consultant-supervised training and sourcing NHS choice.

PURPOSE: Clinical outcomes for phacoemulsification surgery are still compared with the almost 10-year-old benchmark of the 1997-98 National Cataract Surgery Survey (NCSS) published in this journal. Extraneous to the peer-reviewed research literature, more recent databases suggest much better results may be being obtained. This offered the rare opportunity to perform an audit as research investigating if this was indeed the case and a new benchmark is needed, with the additional standard of rigorous study peer review by independent senior ophthalmologists. At this pilot centre for Patient Choice provision, all cataract surgery was performed on Consultant-supervised training lists, a novel extension in-sourcing care using public resources rather than to an independent sector that may not be supervised by NHS Consultants. Patient satisfaction was also surveyed. We asked whether the NCSS is out-of-date, and whether good outcomes on Choice schemes are compatible with Consultant-led training within the National Health Service? METHODS: An audit of 1000 consecutive patients undergoing cataract surgery on Patient Choice at the Western Eye Hospital between October 2002 and September 2004. All subjects were scheduled for phacoemulsification. A novel policy was extending "choice" onto training list slots for this period. A validated questionnaire assessed patient satisfaction. RESULTS: A best corrected visual acuity of 6/12 or better was obtained in 93% of cases. Over 80% of cases were +/-1 D of target refraction (65.7% within 0.5 D). The total incidence of complications was 8.7%. Overall incidence of major complications was 2.4%. Incidence of vitreous loss was 1.1% and that of endophthalmitis 0.1%. Complications rates were lowest for consultants (less than 1%). User satisfaction with having cataract surgery on "patient choice" was high. CONCLUSIONS: Cataract surgery under patient choice on supervised training lists is associated with a visual outcome and an incidence of complications at least as good as the published national average. User satisfaction is high. Cataract surgery under patient choice is compatible with training activity in receiving hospitals. The improvement in outcomes since the 1997-98 NCSS suggest that the accepted standards for complication rates should be updated to reflect the fact that phacoemulsification has become an established procedure.

A comparison of the efficacy of cataract surgery using Aqualase with phacoemulsification using MicroFlow system.

PURPOSE: To compare the outcomes after phacoemulsification performed with the AquaLase and phacoemulsification in MicroFlow system, including surgically induced astigmatism (SIA), corneal endothelial cell damage and postoperative recovery of visual acuity. METHODS: The cataracts of Lens Opacities Classification System, version III (LOCS III) nuclear grade below 2 were subjected in this study. Nineteen eyes underwent cataract operation using AquaLase (Alcon Laboratories, Fort Worth, Texas, U.S.A.). A control group (19 eyes) used the MicroFlow system (Millenium, Stortz, U.S.A.) and was selected by matching age, sex, systemic disease, corneal astigmatism and corneal endothelial cell density. All the surgeries were performed by the same operator. SIA, corneal endothelial cell loss, visual acuity, and corneal thickness were evaluated postoperatively. RESULTS: SIA in the group using AquaLase was less than that of the group using MicroFlow system (P=0.022) at 2 months postoperatively. Evaluation of corneal endothelial cell loss, recovery of visual acuity and corneal thickness found no statistically significant differences between the two groups. CONCLUSIONS: Cataract surgery using AquaLase induces less surgically induced astigmatism in mild to moderate cataracts.