Triamcinolone Acetonide Subconjunctival Injection as Stand-alone Inflammation Prophylaxis after Phacoemulsification Cataract Surgery.

PURPOSE: To compare the effectiveness and safety of a single injection of subconjunctival triamcinolone acetonide (TA) with that of postoperative topical prednisolone acetate (PA) with and without nonsteroidal anti-inflammatory drugs (NSAIDs) for cataract surgery prophylaxis. DESIGN: Retrospective, comparative effectiveness cohort study. PARTICIPANTS: Patients at Kaiser Permanente Northern California from 2018 through 2021. INTERVENTION: Exposure groups included topical PA with or without NSAID and subconjunctival injection of TA (Kenalog; Bristol-Myers-Squibb) 10 mg/ml or 40 mg/ml in a low dose (1.0-3.0 mg) or high dose (3.1-5.0 mg). MAIN OUTCOME MEASURES: The adjusted odds ratio (OR) and 95% confidence interval (CI) for the association of postoperative macular edema (ME) and iritis diagnoses 15 to 120 days after surgery (effectiveness measures) and a glaucoma-related event (safety measure) between 15 days and 1 year after surgery. RESULTS: Of 69 832 eligible patient-eyes, postoperative ME, iritis, and a glaucoma-related event occurred on average in 1.3%, 0.8%, and 3.4% of eyes in the topical groups and 0.8%, 0.5%, and 2.8% of eyes in the injection groups, respectively. In multivariable analysis, compared with the PA reference group, the PA plus NSAID group had a lower OR of ME (OR, 0.88; 95% CI, 0.74-1.04; P = 0.135). and all injection groups had even lower odds, with the high-dose TA 10-mg/ml group reaching statistical significance (OR, 0.64; 95% CI, 0.43-0.97; P = 0.033). A trend of lower odds of a postoperative iritis diagnosis was noted in the high-strength (40 mg/ml) groups. For postoperative glaucoma-related events, compared with PA, the TA 10-mg/ml low-dose group showed lower odds (OR, 0.69; 95% CI, 0.55-0.86; P = 0.001), the TA 10-mg/ml high-dose group showed similar odds (OR, 0.90; 95% CI, 0.70-1.15; P = 0.40), and the TA 40-mg/ml low-dose and high-dose groups showed higher odds of an event occurring (OR, 1.46 [95% CI, 0.98-2.18; P = 0.062] and OR, 2.14 [95% CI, 1.36-3.37; P = 0.001], respectively). CONCLUSIONS: The TA 10-mg/ml high-dose (4 mg) group was associated with a lower risk of postoperative ME and a similar risk of glaucoma-related events compared with the topical groups. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

ASCRS clinical advisory on intracameral moxifloxacin injection for infection prophylaxis.

Moxifloxacin solution is frequently injected at the conclusion of cataract surgery for endophthalmitis prophylaxis. 2 different concentrations are most commonly available in the United States for intracameral (IC) use: 0.5% (5 mg/mL) and 0.1% (1 mg/mL). The recommended volume to be injected is different for the 2 concentrations, and incorrect dosing can increase the risk of toxic anterior segment syndrome or endophthalmitis. In addition, the U.S. Food and Drug Administration recently published an alert regarding potential adverse events associated with intraocular compounded moxifloxacin. This clinical advisory reviews the optimal dosing of IC moxifloxacin based on current evidence.

Endophthalmitis Prophylaxis Failures in Patients Injected With Intracameral Antibiotic During Cataract Surgery.

PURPOSE: To estimate the association of cefuroxime and moxifloxacin in relation to the occurrence of endophthalmitis following phacoemulsification cataract surgery. DESIGN: Retrospective clinical cohort study. METHODS: We studied patients with noncomplex phacoemulsification cataract surgery in Kaiser Permanente Northern California during 2014-2019. Data were obtained for acute, postoperative endophthalmitis within 90 days of phacoemulsification, including culture and antibiogram results, intracameral and topical antibiotic agent, and dose. In a post hoc analysis, we also examined preoperative anterior chamber depth (ACD) and postoperative anterior chamber volume (ACV). RESULTS: Of 216,141 surgeries, endophthalmitis occurred in 0.020% of moxifloxacin-injected eyes and 0.013% of cefuroxime eyes (relative risk 1.62 with 95% CI 0.82-3.20, P = .16). Of the 34 (0.016%) cases of endophthalmitis, cefuroxime 1 mg was injected into 13 eyes and moxifloxacin 0.1% into 21 eyes. Organisms with antibiograms were identified in 12 (35%) cases. Of these, bacteria recovered from cefuroxime-injected eyes were resistant to cefuroxime in all cases (4/4), with Enterococcus comprising half of these. In eyes injected with moxifloxacin 0.1%, 6 out of 7 organisms were sensitive to moxifloxacin injected with 0.1 mL and in 1 eye injected with 1 mL. Streptococcus was the most common organism recovered (6/9) in moxifloxacin-injected eyes. Preoperative ACD and postoperative calculated ACV were higher in eyes injected with moxifloxacin. CONCLUSIONS: Endophthalmitis cases with positive cultures were generally related to organism resistance in cefuroxime eyes but to sensitive organisms in moxifloxacin eyes. Moxifloxacin doses may have been insufficient in eyes with larger ACV.

Three Learning Organizations in Cataract Surgery: The Example of Intracameral Antibiotic Injection.

BACKGROUND: The recent systematic adoption of intracameral antibiotic injection during cataract surgery in Sweden, India, and the US serves as a model for the successful transitioning of local quality improvement initiatives to organization-wide implementation. Although the delivery of eye care in the 3 countries is distinctly organized with differing governances and technological infrastructure, each contains elements of a learning organization (ie, an organization that has adopted a culture of creating, acquiring, and transferring knowledge into practice through system-level and clinician-level change). METHODS: We describe a retrospective and organizational implementation study of intracameral antibiotic injection in Sweden, through the efforts of the National Cataract Registry; in the US by Kaiser Permanente; and in India by the Aravind Eye Hospital System. Leadership structure, training in problem solving, benchmarking, sharing of technical knowledge, and data and workforce engagement are compared. RESULTS: Each of the 3 organizations share the key elements of effective leadership, which values the exchange of ideas in the workforce, training and resourcing for change, and information management in the form of benchmarking and data sharing. In the case of intracameral antibiotic injection, a new technique was identified to improve quality and safety with a reduction in infections as evidence of the success of the programs. CONCLUSION: Committing to a culture of collective learning, and leveraging each stakeholder's personal investment, health-care systems may improve care delivery and set new benchmarks in quality and safety.

Intraocular Pressure Reduction after Phacoemulsification: A Matched Cohort Study.

PURPOSE: Phacoemulsification has been linked to lowered intraocular pressure (IOP) in patients with glaucoma, ocular hypertension, anatomic narrow angles, and in glaucoma suspects, but the magnitude of change has varied. DESIGN: Retrospective cohort study. PARTICIPANTS: Patients with glaucoma treated from June 2010 through May 2015 who underwent phacoemulsification (surgical group) were matched to patients who did not (nonsurgical group) for age, gender, type of glaucoma, baseline IOP, and number and type of glaucoma medications. METHODS: Electronic medical record information was used to compare the matched surgical and nonsurgical groups. MAIN OUTCOME MEASURES: Change in IOP, change in number of glaucoma medications, and likelihood of a glaucoma procedure within 36 months after phacoemulsification. Intraocular pressure measures were obtained from Goldmann applanation tonometry when available (45%), and otherwise with the iCare tonometer (iCare USA, Raleigh, NC), the Tono-Pen (Reichert Technologies, Depew, NY), noncontact tonometry, and pneumotonometry. RESULTS: Among 16 169 matched pairs, average IOP after the index date was lower in the surgical than nonsurgical group throughout follow-up to 36 months. The difference was greatest during months 1 through 18, during which IOP increased by 0.22 mmHg from 16.49 mmHg in the average nonsurgical patient and decreased by 0.99 mmHg from 16.50 mmHg in the average surgical patient (difference in difference, 1.21 mmHg; 95% confidence interval [CI], 1.12-1.30 mmHg). The difference in difference was greatest for patients with ocular hypertension (2.00 mmHg) and for patients with preoperative IOP of 20 mmHg or more (2.46 mmHg). By 30 to 36 months, 5% (95% CI, 4%-6%) fewer surgical patients used an ophthalmic medication. In the surgical group, the odds of selective laser trabeculoplasty were reduced in patients with ocular hypertension (odds ratio [OR], 0.27; 95% CI, 0.10-0.74) or glaucoma suspects (OR, 0.31; 95% CI, 0.20-0.47), whereas the odds of glaucoma surgery were elevated in surgical patients with primary open-angle glaucoma (OR, 1.48; 95% CI, 1.08-2.01). CONCLUSIONS: The association of phacoemulsification for cataract with IOP reduction was lower than in past referral-based studies. Surgeons should expect to reduce IOP approximately 1 to 2 mmHg with phacoemulsification in patients with preoperative IOP of less than 20 mmHg.

Visual outcomes after cataract surgery: topical nonsteroidal anti-inflammatory drug prophylaxis compared with prednisolone.

PURPOSE: To compare visual outcomes in patients without a history of macular edema after phacoemulsification using combination topical nonsteroidal anti-inflammatory drug plus prednisolone with prednisolone alone. SETTING: Kaiser Permanente Northern California, USA. DESIGN: Retrospective cohort study. METHODS: Information was obtained from the electronic health record. The first measure of corrected distance visual acuity (CDVA) recorded during the period 3 weeks to 1 year after phacoemulsification was obtained. Confounding factors and clustering of eyes within patients were adjusted using linear mixed effects regression models for the continuous outcome of CDVA improvement and general estimating equations for the dichotomous outcome of 20/20 or better vs 20/25 or worse. RESULTS: The study included 62 700 health plan members of whom 26,309 (42%) used topical prednisolone alone, whereas 36,391 (58%) used combination treatment. The mean within-person change in CDVA from the preoperative measurement to the postoperative measurement was the same (-0.43 logMAR) for patients in the 2 groups. However, the group that received combination treatment was somewhat more likely to achieve CDVA of 20/20 or better (odds ratio 1.24 with 95% CI, 1.20-1.28). CONCLUSIONS: In this large study of cataract surgery patients, a small statistically significant association of combination treatment compared with prednisolone alone was observed.

Development and Validation of Machine Learning Models: Electronic Health Record Data To Predict Visual Acuity After Cataract Surgery.

BACKGROUND: To develop predictive models of final corrected distance visual acuity (CDVA) following cataract surgery using machine learning algorithms and electronic health record data. METHODS: In this predictive modeling study we used decision tree, random forest, and gradient boosting. We included the first surgical eye of 64,768 members of Kaiser Permanente Northern California who underwent cataract surgery from June 1, 2010 through May 31, 2015. We measured discrimination and calibration of machine learning models for predicting postoperative CDVA 20/50 or worse vs 20/40 or better. RESULTS: The training set included 51,712 patients, and the validation set included 13,056 patients. We compared 3 machine learning models and found that the gradient boosting model provided the best discrimination ability for CDVA. The most important variables for predicting final CDVA 20/50 or worse were preoperative CDVA, age, and age-related macular degeneration, which together accounted for 41% of the gain in optimization of the gradient boosting model. Other important variables in the model included dispensed glaucoma medication, epiretinal membrane, cornea disorder, cataract surgery operating time, surgeon experience, and census block neighborhood characteristics (household income, family income, family poverty, college education, and home residence by owner). CONCLUSION: For predicting CDVA after cataract surgery, gradient boosting had the best ability to discriminate patients with postoperative CDVA 20/50 or worse from patients with postoperative CDVA 20/40 or better. Machine learning has the potential to improve prognosis and can improve patient information when making decisions to undergo cataract surgery.

Drop-free approaches for cataract surgery.

PURPOSE OF REVIEW: Routine prophylaxis for adverse events following cataract surgery is evolving. Prior reliance on topical eyedrop instillation by patients is giving way to surgeon directed injections at the time of cataract surgery. The benefit of this new approach is assured delivery of drugs in standardized doses which should optimize the healing process and reduce the incidence of untoward events with higher confidence. RECENT FINDINGS: Adoption rates of intracameral antibiotic injection amongst European and American cataract surgeons is increasing. Techniques to inject periocular corticosteroid for routine inflammation prophylaxis are also in development. In combination with intraoperative pharmacologic dilation, a drop-free modality can be achieved. SUMMARY: Intraoperative injections offer the patient and surgeon assured drug delivery and hold promise to avoid the pitfalls of patient adherence, incorrect topical instillation, and topical drop-associated corneal issues.

Injection volume and intracameral moxifloxacin dose.

PURPOSE: To test the effect of injection volume and concentration on dosing and residence time of moxifloxacin in the anterior chamber (AC). SETTING: Kaiser Permanente, Walnut Creek, California, USA. DESIGN: Experimental study. METHODS: Moxifloxacin 0.5%/0.05 mL, moxifloxacin 0.5%/0.10 mL, and moxifloxacin 0.15%/0.50 mL were drawn into 5 1.0 mL syringes each, injected into tared vials, and weighed. The doses delivered were calculated. The AC concentrations and elimination rates of the drug for two AC volumes were modeled for each dosing method. RESULTS: The 0.05 mL injection volume resulted in the greatest range (35 µg) of delivered dose compared with larger injection volumes (≤25 µg). The mathematical model predicted that variation in dosing in each group would result in differences of 12 minutes or less for the presence of the drug in the AC. Injection of 0.5%/0.1 mL produced AC concentrations above 500 µg/mL for 1.9 to 3.0 hours and above 64 µg/mL for 5.5 to 6.5 hours, depending on the AC volume; however, flushing with a 0.15% concentration sustained AC levels for 1.9 hours and 5.5 hours, respectively, for the two AC volumes. CONCLUSIONS: Smaller injection volumes of a higher concentration moxifloxacin resulted in less accuracy and less precision in the delivered dose (0.05 mL, P = .005; 0.10 mL, P = .03); however, the clinical significance of this might vary. Injection of 0.5%/0.1 mL and flushing with 0.15%/0.5 mL of moxifloxacin would provide similar drug AC residence times according to the model. Flushing provided more consistent AC concentrations with differing AC volumes.

Visual outcomes after cataract surgery in patients with type 2 diabetes.

PURPOSE: To assess the relation between diabetic retinopathy (DR) severity, duration of diabetes, insulin dependence, and preoperative hemoglobin A1c (HbA1c) with visual outcome after phacoemulsification for cataract in patients with type 2 diabetes. SETTING: Kaiser Permanente Northern California, USA. DESIGN: Retrospective case series. METHODS: Information was obtained from the electronic medical record for patients, June 1, 2010, through May 31, 2015. Confounding factors and clustering of eyes within patients were controlled for using linear mixed-effects regression models for continuous outcomes and general estimating equations for dichotomous outcomes. RESULTS: The study included 65 370 patients; 28% had type 2 diabetes without DR, 5% nonproliferative DR, and 1.2% proliferative DR. Patients with diabetes and no DR were as likely as those without diabetes to achieve a corrected distance visual acuity (CDVA) of 20/20 (odds ratio, 1.01; 95% confidence interval, 0.94-1.10). The odds of a postoperative CDVA of 20/25 or worse increased with the severity of retinopathy duration of diabetes and insulin dependence, but not with the preoperative HbA1c. Although the odds of a postoperative CDVA of 20/20 was lower in patients with DR, every DR group averaged 4 lines of CDVA improvement, the same as patients without diabetes. A longer duration of diabetes, insulin dependence, and elevated HbA1c were not associated with worse postoperative outcomes. CONCLUSION: Patients with DR and cataracts were less likely to achieve a CDVA of 20/20 vision but gained as many lines of CDVA from phacoemulsification as patients without diabetes, showing no evidence that cataract surgery should be delayed in diabetic patients with elevated HbA1c.

Immediate sequential bilateral cataract surgery: surgeon preferences and concerns.

OBJECTIVE: We surveyed cataract surgeons to gain insight into their perceptions of and attitudes about immediate sequential bilateral cataract surgery (ISBCS). DESIGN: Cross-sectional. PARTICIPANTS: All active cataract surgeons in Kaiser Permanente Northern California in 2016. METHODS: Online survey that asked cataract surgeons why they did or did not perform ISBCS, their interest in offering ISBCS, concerns about the procedure, and desired supports. RESULTS: Of the 165 active cataract surgeons, 107 (65%) participated in the survey, of whom 92 (86%) responded that they currently practiced ISBCS and 15 (14%) reported that they did not. For ISBCS surgeons, patient convenience (95%) and patient request (91%) were the top reasons for performing the procedure. For surgeons who do not perform ISBCS, the most commonly cited concerns were not having the postoperative refractive outcome from the first eye to guide intraocular lens selection in the second eye (80%) and risk of bilateral vision loss (73%). Among those who do not perform ISBCS, 9 (60%) identified the need for evidence-based patient selection criteria to support a decision to adopt the procedure. In addition, many surgeons in both groups wanted streamlined patient education materials and established protocols. CONCLUSION: Patient centeredness is a key construct of contemporary health care delivery, and in an era of low complication risk, many patients request ISBCS; the number of these surgeries has increased. In our capitated health care system, the great majority of surgeons perform ISBCS for the convenience of their patients. Providing surgeons with guidelines and tools to support ISBCS likely would increase adoption.

Immediate Sequential vs. Delayed Sequential Bilateral Cataract Surgery: Retrospective Comparison of Postoperative Visual Outcomes.

OBJECTIVE: We conducted a retrospective comparative-effectiveness study of best-corrected visual acuity (BCVA) and refractive error (RE) after immediate sequential (ISBCS) and delayed sequential (DSBCS) bilateral cataract surgery. We tested 2 hypotheses: (1) among DSBCS patients, second-eye outcomes were no different than first-eye outcomes; (2) averaged between each patient's 2 eyes, outcomes did not differ between ISBCS and DSBCS patients. DESIGN: Retrospective comparative-effectiveness study. PARTICIPANTS: Kaiser Permanente Northern California members who underwent noncomplex bilateral cataract surgery from January 1, 2013, through June 30, 2015. METHODS: We performed an intention-to-treat analysis comparing ISBCS to DSBCS using conditional logistic regression analysis, accounting for surgeon and patient-level factors. MAIN OUTCOME MEASURES: BCVA, RE. RESULTS: The analysis of visual outcomes included both eyes of 13 711 DSBCS and 3561 ISBCS patients. Because of the large sample size, some statistical differences lacked clinical significance. Ocular comorbidities were slightly more prevalent in DSBCS patients. Postoperative BCVA was 20/20 or better in 48% of DSBCS first eyes, 49% of DSBCS second eyes, 53% of ISBCS right eyes, and 51% of ISBCS left eyes. The within-person difference in postoperative BCVA averaged zero (0.00) between the first and second DSBCS eyes, and between the ISBCS right and left eyes. After adjustment, average postoperative BCVA was better in ISBCS patients, although the difference was not statistically significant (compared with 20/20 or better: odds ratio for worse than 20/20 was 0.91, 95% confidence interval 0.83-1.01). Emmetropia (spherical equivalent -0.5 to 0 diopter) was achieved in 61% of first DSBCS eyes, 61% of second DSBCS eyes, 63% of ISBCS right eyes, and 63% of ISBCS left eyes. After adjustment, average postoperative RE was no different in ISBCS compared with DSBCS patients (compared with emmetropia: odds ratio for ametropia was 1.02, confidence interval 0.92-1.12). We confirmed 1 case of postoperative endophthalmitis in 10 494 ISBCS eyes (1.0 per 10 000 eyes) and 2 cases in 38 736 DSBCS eyes (0.5 per 10 000 eyes) (P = 0.6), and no patient had bilateral endophthalmitis. CONCLUSIONS: Compared with DSBCS, we found no evidence that ISBCS was associated with worse postoperative BCVA or RE, or with an increased complication risk.

Failure Modes and Effects Analysis of bilateral same-day cataract surgery.

PURPOSE: To systematically analyze potential process failures related to bilateral same-day cataract surgery toward the goal of improving patient safety. SETTING: Twenty-one Kaiser Permanente surgery centers, Northern California, USA. DESIGN: Retrospective cohort study. METHODS: Quality experts performed a Failure Modes and Effects Analysis (FMEA) that included an evaluation of sterile processing, pharmaceuticals, perioperative clinic and surgical center visits, and biometry. Potential failures in human factors and communication (modes) were identified. Rates of endophthalmitis, toxic anterior segment syndrome (TASS), and unintended intraocular lens (IOL) implantation were assessed in eyes having bilateral same-day surgery from 2010 through 2014. RESULTS: The study comprised 4754 eyes. The analysis identified 15 significant potential failure modes. These included lapses in instrument processing and compounding errors of intracameral antibiotics that could lead to endophthalmitis or TASS, and ambiguous documentation of IOL selection by surgeons, which could lead to unintended IOL implantation. Of the study sample, 1 eye developed endophthalmitis, 1 eye had unintended IOL implantation (rates, 2 per 10 000; 95% confidence interval [CI], 0.1-12.0 per 10 000), and no eyes developed TASS (upper 95% CI, 8 per 10 000). Recommendations included improving oversight of cleaning and sterilization practices, separating lots of compounded drugs for each eye, and enhancing IOL verification procedures. CONCLUSIONS: Potential failure modes and recommended actions in bilateral same-day cataract surgery were determined using an FMEA. These findings might help improve the reliability and safety of bilateral same-day cataract surgery based on current evidence and standards.

Natural language processing to ascertain two key variables from operative reports in ophthalmology.

PURPOSE: Antibiotic prophylaxis is critical to ophthalmology and other surgical specialties. We performed natural language processing (NLP) of 743 838 operative notes recorded for 315 246 surgeries to ascertain two variables needed to study the comparative effectiveness of antibiotic prophylaxis in cataract surgery. The first key variable was an exposure variable, intracameral antibiotic injection. The second was an intraoperative complication, posterior capsular rupture (PCR), which functioned as a potential confounder. To help other researchers use NLP in their settings, we describe our NLP protocol and lessons learned. METHODS: For each of the two variables, we used SAS Text Miner and other SAS text-processing modules with a training set of 10 000 (1.3%) operative notes to develop a lexicon. The lexica identified misspellings, abbreviations, and negations, and linked words into concepts (e.g. "antibiotic" linked with "injection"). We confirmed the NLP tools by iteratively obtaining random samples of 2000 (0.3%) notes, with replacement. RESULTS: The NLP tools identified approximately 60 000 intracameral antibiotic injections and 3500 cases of PCR. The positive and negative predictive values for intracameral antibiotic injection exceeded 99%. For the intraoperative complication, they exceeded 94%. CONCLUSION: NLP was a valid and feasible method for obtaining critical variables needed for a research study of surgical safety. These NLP tools were intended for use in the study sample. Use with external datasets or future datasets in our own setting would require further testing. Copyright © 2017 John Wiley & Sons, Ltd.

Pathogens and antibiotic sensitivities in endophthalmitis.

BACKGROUND: Antibiotic prophylaxis in cataract surgery is intended to minimize endophthalmitis. We describe pathogenic organisms, antibiotic sensitivities and antibiotic prophylaxis in culture-proven endophthalmitis cases. DESIGN: Retrospective consecutive case series and community-based setting were used. PARTICIPANTS: Two hundred fifteen cases of endophthalmitis after cataract surgery performed during 2007-2012 in Kaiser Permanente, California. METHODS AND MAIN OUTCOME MEASURES: Descriptive analysis of isolated organisms and antibiotic sensitivities in relation to antibiotic prophylaxis in culture-proven endophthalmitis cases. RESULTS: The majority of culture-confirmed organisms (n = 83) were Gram positive (96%), most notably coagulase-negative Staphylococci (n = 34, 52%), of which all that underwent testing were sensitive to vancomycin (n = 32). Among 19 cases that had received only topical antibiotic prophylaxis, seven (37%) were resistant to the antibiotic given: 50% of cases (5 of 10 isolates) that had received ofloxacin were resistant to this antibiotic, 40% (2 of 5 isolates) that had received gatifloxacin were resistant. In contrast, 100% of cases (n = 4) that had received aminoglycosides were susceptible. Few culture-confirmed cases occurred in patients who received intracameral antibiotic (n = 4). CONCLUSIONS: In cases where fluoroquinolones were administered as antibiotic prophylaxis, isolates demonstrated a degree of bacterial resistance. The majority of endophthalmitis cases isolated occured following topical antibiotic prophylaxis only and were attributed to Gram-positive organisms, while few occurred in association with intracameral antibiotic.