Early Endophthalmitis Incidence and Risk Factors after Glaucoma Surgery in the Medicare Population from 2016 to 2019.

PURPOSE: To determine early endophthalmitis incidence and risk factors after glaucoma surgeries in the Medicare population. DESIGN: Retrospective, longitudinal study. PARTICIPANTS: Medicare Fee-for-Service (FFS) and Medicare Advantage beneficiaries in the United States aged 65 years or older undergoing glaucoma surgery. METHODS: Medicare claims were used to identify all patients who underwent glaucoma, cataract, or combined cataract/glaucoma surgery from 2016 to 2019. Endophthalmitis cases within 42 days of the index surgery were identified using the diagnostic codes. Multivariable logistic regression models were used to evaluate factors associated with postoperative endophthalmitis. MAIN OUTCOME MEASURES: The 42-day postoperative endophthalmitis incidence and risk factors associated with endophthalmitis after glaucoma surgery. RESULTS: There were 466 928 glaucoma surgeries, of which 310 823 (66.6%) were combined with cataract surgery. Cataract surgeries alone (n = 8 460 360) served as a reference group. Microinvasive glaucoma surgeries constituted most glaucoma procedures performed (67.8%), followed by trabeculectomy (14.0%), tube shunt (10.9%), and other procedures (7.3%). There were 572 cases of endophthalmitis identified after all glaucoma surgeries. Endophthalmitis incidence after glaucoma, combined cataract/glaucoma, and cataract surgeries alone was 1.5 (95% confidence interval [CI], 1.3-1.7), 1.1 (95% CI, 1.0-1.2), and 0.8 (95% CI, 0.8-0.8) per 1000 procedures, respectively. The median day of diagnosis of endophthalmitis was later for glaucoma surgeries (16.5 days) compared with combined cataract/glaucoma or cataract surgeries alone (8 and 6 days, respectively). Compared with microinvasive glaucoma surgery (MIGS), tube shunts were the only surgery type to be a significant risk factor for endophthalmitis for both stand-alone (adjusted odds ratio [aOR], 1.8, P = 0.002) and combined surgery (aOR 1.8, P = 0.047). The other risk factor for both stand-alone (aOR 1.1, P = 0.001) and combined (aOR 1.06, P = 0.049) surgeries was the Charlson Comorbidity Index (CCI). Age (aOR 1.03, P = 0.004) and male gender (1.46, P = 0.001) were significant risk factors for combined cataract and glaucoma surgeries. CONCLUSIONS: Compared with cataract surgery, early endophthalmitis incidence was higher for both glaucoma and combined cataract/glaucoma surgeries, with the highest incidence among tube shunts. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Intracameral antibiotics during cataract surgery: efficacy, safety, and cost-benefit considerations.

PURPOSE OF REVIEW: We summarize evidence-based considerations regarding the use of intracameral antibiotics during cataract surgery. RECENT FINDINGS: The use of intraoperative intracameral antibiotics reduced the incidence of postcataract surgery endophthalmitis 3.5-fold, with an odds ratio ranging from 0.14 to 0.19. A survey of the American Society of Cataract and Refractive Surgery showed usage of intracameral injections of antibiotics increased by 16% in the United States between 2014 and 2021. The frequency of vancomycin usage has sharply dropped to 6%, while moxifloxacin is now the dominant choice at 83% among respondents. One analysis showed that 2500 patients need to be treated with intracameral antibiotics to prevent one case of endophthalmitis. A 500 µg intracameral moxifloxacin at $22 dollars per dose is cost-effective, including for patients with posterior capsular rupture (PCR). SUMMARY: Studies substantiate the safety and efficacy of intracameral antibiotics for endophthalmitis prophylaxis. Intracameral moxifloxacin and cefuroxime are the most common choices. While vancomycin shows potential for efficacy, further studies evaluating clinical outcomes are needed. Adverse events are rare and commonly due to errors in preparation. Topical antibiotics do not provide additional prophylactic benefits to intracameral regimens. Intracameral antibiotics given alone are cost-effective.

Endophthalmitis rates and risk factors following intraocular surgeries in the medicare population from 2016 to 2019.

AIMS: To determine endophthalmitis rates and risk factors following intraocular surgeries in the Medicare population. METHODS: Retrospective, cross-sectional study from 2016 to 2019 in Medicare fee-for-service and Medicare Advantage beneficiaries. 100% Medicare claims were used to identify eyes that underwent intraocular surgery. Exclusion criteria included eyes that had intraocular surgery 42 days before or after and eyes in patients with a history of endophthalmitis within 12 months. RESULTS: 9 744 400 intraocular surgeries were performed among Medicare beneficiaries from 2016 to 2019. A 42-day postoperative endophthalmitis rate was 0.09%. Endophthalmitis rate by surgery type was 0.43% for corneal transplant, 0.36% for secondary intraocular lens (IOL), 0.24% for retina, 0.16% for glaucoma, 0.11% for cataract combined with other procedures and 0.08% for cataract surgeries alone. On multivariable analysis, the risk of endophthalmitis was increased for all intraocular surgery types when compared with cataract surgeries; adjusted OR (aOR) 5.30 (p<0.01) for corneal transplant, aOR 4.50 (p<0.01) for secondary IOL, aOR 3.00 (p<0.01) for retina, aOR 1.93 (p<0.01) for glaucoma, aOR 1.45 (p<0.01) for combined cataract surgeries. Increased risk of developing endophthalmitis was associated with older age (≥85 vs 65-75 years: aOR 1.36; p<0.01), male sex (aOR 1.20; p<0.001) and greater Charlson Comorbidity Index (≥7 vs 0: aOR 1.79; p<0.01). CONCLUSIONS: Postoperative endophthalmitis rate after intraocular surgeries was 0.09% between 2016 and 2019 for Medicare beneficiaries. Endophthalmitis rates were highest for corneal transplant surgeries followed by secondary IOL surgeries and lowest for cataract surgeries. Older age, male gender and higher comorbidity index were associated with risk of endophthalmitis.

Understanding the science of fungal endophthalmitis - AIOS 2021 Sengamedu Srinivas Badrinath Endowment Lecture.

Fungal endophthalmitis is a potentially blinding condition. It is more often reported from Asia, including India. The incidence is lower than bacterial endophthalmitis. But it is relatively more challenging to treat than bacterial endophthalmitis. Many eyes may need therapeutic keratoplasty and/or evisceration. The current mainstays of treatment are vitrectomy irrespective of the presenting vision, intravitreal antifungal agents, and systemic therapy; additionally, the patients could require prolonged treatment with repeat vitreous surgeries and intravitreal injections. Difficulty in clinical diagnosis, delay in microbiological culture, and limited options of antifungal drugs make the treatment more difficult and less rewarding. Three common fungi causing endophthalmitis are Aspergillus, Fusarium, and Candida. The former two are molds, often identified in exogenous endophthalmitis, postoperative and traumatic; the latter is yeast and is more often identified in endogenous endophthalmitis. A faster diagnosis with newer molecular microbiological technologies might help institute treatment earlier than it is currently possible. A target trial using big data from different regions of the world might emulate a randomized clinical trial to design a definite treatment strategy. Given fewer antifungal drugs, one must be mindful of antifungal stewardship to prevent resistance to the existing drugs.

Incidence and management of acute endophthalmitis after intravitreal injection of bevacizumab.

PURPOSE: To report the incidence, management, and clinical outcomes of cases who developed acute endophthalmitis following the administering of the intravitreal bevacizumab (IVB) injection. METHODS: In this retrospective, non-comparative, single-center, cross-sectional study, the records of patients diagnosed with acute endophthalmitis following IVB injection between March 2013 and October 2019 were reviewed. Immediate injection of intravitreal antibiotics and early pars plana vitrectomy was performed for all cases after clinical diagnosis of acute post IVB endophthalmitis. RESULTS: A total of 28,085 IVB injections were performed during the study period. Nine eyes of nine patients developed acute post IVB endophthalmitis giving an overall incidence of 0.032% (95% CI, 0.01-0.06) (3.2 in 10,000 injections). Three cases (33%) were culture-positive (staphylococcus epidermidis). The mean time between IVB injection and presentation of endophthalmithis was 2.77 ± 1.25 days (Range, 1-6). The mean number of previously received IVB injections before developing of endophthalmitis was 4 ± 1.5 (range 2 to7). The mean best corrected visual acuity (BCVA) before IVB injection, at the presentation of endophthalmithis and three months after the treatment of endophthalmithis were 1.18 ± 0.62, 2.5 ± 0.42, and 1.94 ± 0.88 logMAR, respectively (P = 0.025). One eye developed phthisis bulbi. CONCLUSION: The incidence of acute endophthalmitis following Intravitreal injection of bevacizumab is very low. The time interval between injection and presentation is short. Prompt treatment with immediate intravitreal antibiotics and early pars plana vitrectomy are key in maximizing outcomes. The prognosis of post-IVB endophthalmitis is poor and may result in significantly visual impairment.

Comparison of post-cataract surgery endophthalmitis rates using syringing or regurgitation on pressure over the lacrimal sac as a preoperative screening tool for nasolacrimal duct obstruction: An impact assessment of protocol alteration due to the COVID-19 pandemic.

Purpose: To compare the post-cataract endophthalmitis (PCE) rates among eyes undergoing syringing or regurgitation on pressure over the lacrimal sac (ROPLAS) test prior to cataract surgery. Methods: We performed a single-center, retrospective, comparative analysis of eyes developing PCE who underwent syringing prior to cataract surgery (group A) in the pre-COVID-19 era between November 1 2019 and January 31, 2020 and the eyes that underwent ROPLAS test prior to cataract surgery (group B) in the COVID-19 era between November 1, 2020 and January 31, 2021. Results: A total of 87,144 eyes underwent cataract surgery during the two time periods of the study. Syringing was performed in 48,071 eyes, whereas ROPLAS was performed in 39,073 eyes. In group A, 19 eyes (0.039%) developed PCE, whereas 20 eyes (0.051%) developed PCE in group B (P = 0.517). Between the two groups, the grade of anterior chamber cellular reaction (P = 0.675), hypopyon (P = 0.738), and vitreous haze (P = 0.664) were comparable. Gram-positive organisms were detected in 4 eyes in group A and 6 eyes in group B; 2 eyes in group A had gram-negative bacilli. The presenting visual acuity (Group A: LogMAR 1.42 and Group B: LogMAR 1.30) and final visual acuity (Group A: LogMAR 0.52 and Group B: LogMAR 0.5) were comparable between the two groups. (P = 0.544 and 0.384, respectively). Conclusion: The rates of PCE were comparable among the eyes undergoing either syringing test or ROPLAS prior to cataract surgery.

Endophthalmitis Post Pars Plana Vitrectomy Surgery: Incidence, Organisms' Profile, and Management Outcome in a Tertiary Eye Hospital in Saudi Arabia.

PURPOSE: To determine the incidence of endophthalmitis after pars plana vitrectomy (PPV), organisms' profile, and management outcomes at a tertiary eye hospital in a Middle East country. METHODS: In this single-arm cohort study conducted in 2020, medical records of patients who underwent PPV not accompanied by any other intraocular surgery were reviewed; those with a diagnosis of acute endophthalmitis in the immediate postoperative period (within 6 weeks) during the past 6 years were analyzed. RESULTS: A total of 8153 records of PPV surgeries were reviewed. Five cases had endophthalmitis post-PPV with an incidence of 0.061%. Three (0.037%) had positive cultures, all of them for Staphylococcus epidermidis. The interval between PPV and diagnosis of endophthalmitis ranged from 3 to 25 days (mean, 15.8 days). Final vision after treatment ranged from 20/400 to no light perception, and one eye was eviscerated. CONCLUSION: The incidence of endophthalmitis post PPV is low. Despite prompt diagnosis and standard management, visual prognosis seems to be poor. The infective agents for endophthalmitis were commensals from the ocular surface.

Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration.

BACKGROUND: Age-related macular degeneration (AMD) is one of the leading causes of permanent blindness worldwide. The current mainstay of treatment for neovascular AMD (nAMD) is intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents: aflibercept, ranibizumab, and off-label bevacizumab. Injections can be given monthly, every two or three months ('extended-fixed'), or as needed (pro re nata (PRN)). A variant of PRN is 'treat-and-extend' whereby injections are resumed if recurrence is detected and then delivered with increasing intervals. Currently, injection frequency varies among practitioners, which underscores the need to characterize an optimized approach to nAMD management. OBJECTIVES: To investigate the effects of monthly versus non-monthly intravitreous injection of an anti-VEGF agent in people with newly diagnosed nAMD. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, LILACS, and three trials registers from 2004 to October 2019; checked references; handsearched conference abstracts; and contacted pharmaceutical companies to identify additional studies. SELECTION CRITERIA: We included randomized controlled trials (RCTs) that compared different treatment regimens for anti-VEGF agents in people with newly diagnosed nAMD. We considered standard doses only (ranibizumab 0.5 mg, bevacizumab 1.25 mg, aflibercept 2.0 mg, or a combination of these). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods for trial selection, data extraction, and analysis. MAIN RESULTS: We included 15 RCTs. The total number of participants was 7732, ranging from 37 to 2457 in each trial. The trials were conducted worldwide. Of these, six trials exclusively took place in the US, and three included centers from more than one country. Eight trials were at high risk of bias for at least one domain and all trials had at least one domain at unclear risk of bias. Seven trials (3525 participants) compared a PRN regimen with a monthly injection regimen, of which five trials delivered four to eight injections using standard PRN and three delivered nine or 10 injections using a treat-and-extend regimen in the first year. The overall mean change in best-corrected visual acuity (BCVA) at one year was +8.8 letters in the monthly injection group. Compared to the monthly injection, there was moderate-certainty evidence that the mean difference (MD) in BCVA change at one year for the standard PRN subgroup was -1.7 letters (95% confidence interval (CI) -2.8 to -0.6; 4 trials, 2299 participants), favoring monthly injections. There was low-certainty evidence of a similar BCVA change with the treat-and-extend subgroup (0.5 letters, 95% CI -3.1 to 4.2; 3 trials, 1226 participants). Compared to monthly injection, there was low-certainty evidence that fewer participants gained 15 or more lines of vision with standard PRN treatment at one year (risk ratio (RR) 0.87, 95% CI 0.76 to 0.99; 4 trials, 2299 participants) and low-certainty evidence of a similar gain with treat-and-extend versus monthly regimens (RR 1.11, 95% CI 0.91 to 1.36; 3 trials, 1169 participants). The mean change in central retinal thickness was a decrease of -166 µm in the monthly injection group; the MD compared with standard PRN was 21 µm (95% CI 6 to 32; 4 trials, 2215 participants; moderate-certainty evidence) and with treat-and extend was 22 µm (95% CI 37 to -81 µm; 2 trials, 635 participants; low-certainty evidence), in favor of monthly injection. Only one trial (498 participants) measured quality of life and reported no evidence of a difference between regimens, but data could not be extracted (low-certainty evidence). Both PRN regimens (standard and 'treat-and-extend') used fewer injections than monthly regimens (standard PRN: MD -4.6 injections, 95% CI -5.4 to -3.8; 4 trials, 2336 participants; treat-and-extend: -2.4 injections, 95% CI -2.7 to -2.1 injections; moderate-certainty evidence for both comparisons). Two trials provided cost data (1105 participants, trials conducted in the US and the UK). They found that cost differences between regimens were reduced if bevacizumab rather than aflibercept or ranibizumab were used, since bevacizumab was less costly (low-certainty evidence). PRN regimens were associated with a reduced risk of endophthalmitis compared with monthly injections (Peto odds ratio (OR) 0.13, 95% CI 0.04 to 0.46; 6 RCTs, 3175 participants; moderate-certainty evidence). Using data from all trials included in this review, we estimated the risk of endophthalmitis with monthly injections to be 8 in every 1000 people per year. The corresponding risk for people receiving PRN regimens was 1 in every 1000 people per year (95% CI 0 to 4). Three trials (1439 participants) compared an extended-fixed regimen (number of injections reported in only one large trial: 7.5 in one year) with monthly injections. There was moderate-certainty evidence that BCVA at one year was similar for extended-fixed and monthly injections (MD in BCVA change compared to extended-fixed group: -1.3 letters, 95% CI -3.9 to 1.3; RR of gaining 15 letters or more: 0.94, 95% CI 0.80 to 1.10). The change in central retinal thickness was a decrease of 137 µm in the monthly group; the MD with the extended-fixed group was 8 µm (95% CI -11 to 27; low-certainty evidence). The frequency of endophthalmitis was lower in the extended-fixed regimen compared to the monthly group, but this estimate was imprecise (RR 0.19, 95% CI 0.03 to 1.11; low-certainty evidence). If we assumed a risk of 8 cases of endophthalmitis in 1000 people receiving monthly injections over one year, then the corresponding risk with extended-fixed regimen was 2 in 1000 people (95% CI 0 to 9). Other evidence comparing different extended-fixed or PRN regimens yielded inconclusive results. AUTHORS' CONCLUSIONS: We found that, at one year, monthly regimens are probably more effective than PRN regimens using seven or eight injections in the first year, but the difference is small and clinically insignificant. Endophthalmitis is probably more common with monthly injections and differences in costs between regimens are higher if aflibercept or ranibizumab are used compared to bevacizumab. This evidence only applies to settings in which regimens are implemented as described in the trials, whereas undertreatment is likely to be common in real-world settings. There are no data from RCTs on long-term effects of different treatment regimens.

Posttraumatic Endophthalmitis in children: Epidemiology, Diagnosis, Management, and Prognosis.

Pediatric posttraumatic endophthalmitis presents with great complexities and challenges arising due to delayed presentation, difficulty in eliciting an accurate history, or trauma with unusual and highly contaminated objects. The possibility of initial misdiagnosis as panuveitis, metastatic endophthalmitis, and masquerade syndrome is also very high, which results not only in several unwarranted investigations being performed, but also a delay in the initiation of treatment. The standard treatment remains primary repair of the wound, intravitreal therapy with broad spectrum antibiotics, and parsplana vitrectomy. Despite appropriate intervention, visual outcome in children with posttraumatic endophthalmitis is dampened by additional factors like poor compliance with postoperative instructions and high risk of amblyopia. Hence, it is important to recognize that posttraumatic endophthalmitis in children differs from that in adults in several ways. We made a very tailored effort to review the published literature pertaining to posttraumatic endophthalmitis in children and herein present the results of our search.

Intraocular use of bevacizumab in India: An issue resolved?

Bevacizumab is a monoclonal antibody against vascular endothelial growth factor (VEGF), which has been approved for intravenous use in certain cancers. There is evidence of its efficacy and safety as an intravitreal drug compared with ranibizumab and aflibercept. We have, in our practice, found it to be a cost-effective treatment option for ocular diseases, which could save a large amount of public money used in various national health insurance systems. An alert issued by the Drug Controller General of India led to a virtual ban on its intraocular use in India. However, pro-active advocacy and leadership by national ophthalmological societies helped to resolve the issue quickly.

Endophthalmitis after intravitreal injections. Incidence, management and prognosis. / Endoftalmitis tras inyecciones intravítreas. Incidencia, manejo y pronóstico.

OBJECTIVE: To assess the rate of endophthalmitis after intravitreal injection (IVI) in a «clean room¼ of a single health centre, following the guidelines of the Spanish Vitreo-Retinal Society (SERV). An analysis was performed on the culture specimens, response to treatment, and final outcomes (guidelines). MATERIAL AND METHODS: A retrospective, observational study was conducted on a consecutive case series of patients diagnosed with infectious endophthalmitis after IVI in a single health centre between 2010 and 2015. Intravitreal and systemic treatment was given following the SERV guidelines. The patients were followed up the case was resolved. RESULTS: There were 5 cases of endophthalmitis out of 9467 IVI (incidence 0.053%). Positive cultures were obtained in aqueous and/or vitreous fluid in all cases, with Staphylococcus epidermidis being involved in 4 out of 5 cases. In 2 cases, final visual acuity was non-light perception due to intractable retinal detachments after resolution of the infectious process. CONCLUSIONS: IVI performed in a «clean room¼ have a low incidence of endophthalmitis. The most common infectious agent was Staphylococcus species. In 2 cases the functional prognosis was poor.

Severe Ocular Inflammation Following Ranibizumab or Aflibercept Injections for Age-Related Macular Degeneration: A Retrospective Claims Database Analysis.

PURPOSE: Intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents including ranibizumab and aflibercept are used to treat patients with ocular disorders such as neovascular age-related macular degeneration (nAMD); however, the injections are associated with rare instances of severe ocular inflammation. This study compared severe ocular inflammation rates in patients treated with ranibizumab versus aflibercept. METHODS: United States physician-level claims data covering an 18-month period for each therapy were analyzed. The primary analysis compared severe ocular inflammation event rates per 1000 injections. Sensitivity and subgroup analyses evaluated the impact of factors including intraocular surgery, intravitreal antibiotic administration, and previous intravitreal injections. RESULTS: The analysis included 432,794 injection claims (ranibizumab n = 253,647, aflibercept n = 179,147); significantly, more unique severe ocular inflammation events occurred in patients receiving aflibercept than ranibizumab (1.06/1000 injections, 95% confidence interval [CI], 0.91-1.21, vs. 0.64/1000 injections, 95% CI 0.54-0.74; p < 0.0001). Comparable results were observed for analyses of patients who had undergone glaucoma or cataract surgeries, had antibiotic-associated endophthalmitis, had non-antibiotic-associated endophthalmitis, and were non-treatment-naive. In contrast, no significant differences in severe ocular inflammation claims were recorded in treatment-naive patients who had no record of anti-VEGF treatment in the 6 months preceding the index claim. No significant change occurred in the rate of severe ocular inflammation claims over time following ranibizumab treatment. CONCLUSIONS: Severe ocular inflammation was more frequent following intravitreal injection with aflibercept than with ranibizumab during routine clinical use in patients with nAMD. This highlights the importance of real-world, post-approval, observational monitoring of novel medicines, and may aid clinical decision-making, including choice of anti-VEGF agent.

Effect of Prior Anti-VEGF Injections on the Risk of Retained Lens Fragments and Endophthalmitis after Cataract Surgery in the Elderly.

PURPOSE: To investigate the effect of prior intravitreal anti-vascular endothelial growth factor (VEGF) injections on surgical and postoperative complication rates associated with cataract surgery in a nationally representative longitudinal sample of elderly persons. DESIGN: Retrospective, longitudinal cohort analysis. PARTICIPANTS: A total of 203 643 Medicare beneficiaries who underwent cataract surgery from January 1, 2009, to December 31, 2013. METHODS: By using the 5% sample of Medicare claims data, the study assessed risks of 3 adverse outcomes after receipt of cataract surgery for beneficiaries with a history of intravitreal injections. Risks of these outcomes in beneficiaries with a history of intravitreal injections relative to those without were calculated using the Cox proportional hazard model. MAIN OUTCOME MEASURES: The primary outcome was the risk of subsequent removal of retained lens fragments (RLFs) within 28 days after cataract surgery. Secondary outcomes were a new diagnosis of acute (<40 days) or delayed-onset (40+ days) endophthalmitis and risk of a new primary open-angle glaucoma (POAG) diagnosis within 365 days after cataract surgery. RESULTS: Prior intravitreal anti-VEGF injections were associated with a significantly increased risk of subsequent RLF removal within 28 days after cataract surgery (hazard ratio [HR], 2.26; 95% confidence interval [CI], 1.19-4.30). Prior injections were also associated with increased risk of both acute (HR, 2.29; 95% CI, 1.001-5.22) and delayed-onset endophthalmitis (HR, 3.65; 95% CI, 1.65-8.05). Prior injections were not a significant indicator of increased risk of a new POAG diagnosis. CONCLUSIONS: A history of intravitreal injections may be a risk factor for cataract surgery-related intraoperative complications and endophthalmitis. Given the frequency of intravitreal injections and cataract surgery, increased preoperative assessment, additional intraoperative caution, and postoperative vigilance are recommended in patients with a history of intravitreal injections undergoing cataract extraction.

Budget impact assessment of Aprokam® compared with unlicensed cefuroxime for prophylaxis of post-cataract surgery endophthalmitis.

BACKGROUND: Intracameral cefuroxime is recommended as prophylaxis against postoperative endophthalmitis (POE) following cataract surgery. Aprokam is the only licensed product for prophylaxis of POE, although unlicensed intracameral cefuroxime may be administered using pre-filled syringes (PFS), either prepared in hospital by reconstituting cefuroxime via serial dilution (prepared PFS), or commercially purchased (purchased PFS). This study aimed to estimate the potential budget impact of using Aprokam over unlicensed cefuroxime for intracameral administration. METHODS: A budget impact model (BIM) was developed from UK NHS hospital perspective to estimate the economic impact of adopting Aprokam compared with purchased PFS or prepared PFS for the prophylaxis of POE following cataract surgery over a 5-year time horizon. The BIM incorporated direct costs only, associated with the acquisition, delivery, storage, preparation, and administration of cefuroxime. Resource utilisation costs were also incorporated; resource utilisation was sourced from a panel survey of hospital pharmacists, surgeons, and theatre nurses who are involved in the delivery, storage, preparation, quality assurance, or administration of cefuroxime formulations. Unit costs were sourced from NHS sources; drug acquisition costs were sourced from BNF. The model base case used a hypothetical cohort comprising of 1000 surgeries in the first year and followed a 5.2 % annual increase each year. RESULTS: The model predicts Aprokam is cost saving compared with purchased PFS, with a modest increase compared prepared PFS over 5 years. There are total savings of £ 3490 with Aprokam compared with purchased PFS, driven by savings in staff costs that offset greater drug acquisition costs. Compared with prepared PFS, there are greater drug acquisition costs which drive an increased total cost over 5 years of £ 13,177 with Aprokam, although there are substantial savings in staff costs as well as consumables and equipment costs. CONCLUSIONS: The lower direct costs of using Aprokam compared with purchased PFS presents a strong argument for the adoption of Aprokam where purchased PFS is administered. The additional benefits of Aprokam include increased liability coverage and possible reduction in dilution errors and contaminations; as such, in hospitals where unlicensed prepared PFS is used, modest additional resources should be allocated to adoption of Aprokam.

Adverse vitreoretinal outcomes of glaucoma drainage devices based on verified and unverified financial claims data.

BACKGROUND AND OBJECTIVE: To determine adverse vitreoretinal outcome rates after glaucoma drainage device (GDD) surgery. PATIENTS AND METHODS: Medical records from the Anne Bates Leach Eye Hospital with financial claims from 1991 to 2005 for GDD surgery coded for endophthalmitis, choroidal hemorrhage, or retinal detachment were reviewed. Cumulative incidences were calculated before and after verifying claims with chart review. RESULTS: GDD surgery was performed in 2,661 eyes. Thirty-three cases of endophthalmitis were identified, with 10 attributable to GDD (1-, 5-, and 10-year cumulative incidences: 0.22%, 0.43%, and 0.83%, respectively). Forty cases of choroidal hemorrhage were identified, with 20 attributable to GDD (1-, 5-, and 10-year incidences: 0.81% for all time points). Rhegmatogenous retinal detachments developed in 148 eyes, with 42 attributable to GDD (1-, 5-, and 10-year incidences: 1.25%, 2.02%, and 2.67%, respectively). CONCLUSION: This study's complication rates compare favorably with those previously reported. The use of claims data without chart review verification may result in overestimated event rates.

Quality assessment of cataract surgery in Denmark - risk of retinal detachment and postoperative endophthalmitis.

The main purpose of this thesis was to examine whether the Danish National Patient Registry (NPR) could be used to monitor and assess the quality of cataract surgery in Denmark by studying the risks of two serious postoperative complications following cataract surgery - retinal detachment (RD) and postoperative endophthalmitis (PE). The thesis consists of four retrospective studies. In the first study (paper I), we used data from the NPR in the calendar period 2000-2010 to investigate the risk of pseudophakic retinal detachment (PRD) using the fellow non-operated eyes of the patients as reference. The study showed that over a 10-year study period, the risk of PRD was increased by a factor of 4.2 irrespective of sex and age. The risk of PRD was highest in the first part of the postoperative period and then gradually decreased but remained statistically significantly higher than the risk of RD in non-operated fellow eyes up to 10 years after cataract surgery. The epidemiology of RD in the non-operated fellow eyes was different from the epidemiology of RD in the background population as young men had the highest risk of RD in the non-operated fellow eyes. This means that the absolute risk of PRD was highest for young men because they had a higher risk of RD before they underwent cataract surgery. In the second study (paper II), we used data from the NPR and reviewed patient charts to assess the risk of PE after cataract surgery performed in public eye departments and private hospitals/clinics in the study period 2002-2010. The overall risk of PE among the seven public eye departments was 0.36 per 1000 registered cataract operations, and the PE risk among the departments was homogeneous. The overall risk of PE among the 28 private hospitals/clinics was 0.73 per 1000 registered cataract operations, and the risk among the private hospitals/clinics was heterogeneous. Most private hospitals/clinics had a risk of PE that was lower than or similar to the risk of PE after registered cataract surgery in public eye departments, but six private hospitals/clinics had a statistically significantly higher risk of PE compared to the public eye departments. We used PE as a proxy measure of the registration of cataract surgery and found that 98% of the cataract operations performed in public eye departments were registered in the NPR while only 38% of the cataract operations performed in private hospitals/clinics were registered in the NPR. In general, the coding of the PE cases was not uniform and the lack of registration by the private hospitals/clinics meant that the NPR could not be used to monitor the true risk of PE. NPR data were also used in the third study (paper III) to examine whether patients who had surgical intervention for PE following cataract surgery with either a pars plana vitrectomy (PPV) or a vitreous tap (VT) had a higher risk of subsequent surgical complications. There was no statistically significant difference in the overall risk of complications among the two groups, but the risk of surgery for vitreous opacities was statistically significantly higher for patients who underwent a VT. A surgical complication occurred in 27.3% of the patients and 9.9% of the patients developed more than one surgical complication. Ninety-seven per cent of the primary surgical complications occurred within the first 5 months. The risk of surgical complications in this study was similar to or higher than the risk of complications in the landmark Endophthalmitis Vitrectomy Study from the early 1990s. In the fourth study (paper IV), we used data from all three Danish cataract registries to describe the epidemiology of cataract operations performed in public hospitals and private hospitals/clinics in the study period 2004-2012. Again, PE was used as a proxy measure of the registration of cataract surgery. There were several noticeable differences in the epidemiology of the cataract operations performed in public hospitals and private hospitals/clinics. Patients who had cataract surgery in public hospitals had a statistically significantly higher mortality compared to patients who had cataract surgery in private hospitals/clinics during the entire period. The decrease in the mean age at first eye cataract surgery in private hospitals/clinics was statistically significantly greater compared to public hospitals during the study period. There was a statistically significantly shorter median time interval between first and second eye cataract surgery at private hospitals/clinics compared to public hospitals during the entire study period. The study showed that only 54% of the cataract operations performed in private hospitals/clinics that led to PE were registered. The lack of registration of cataract surgery is the main reason why the NPR has limitations when used as a tool to monitor and assess the quality of cataract surgery in Denmark.

Ocular complications after anti-vascular endothelial growth factor therapy in Medicare patients with age-related macular degeneration.

PURPOSE: To determine longitudinal rates of ocular complications after anti-vascular endothelial growth factor (VEGF) treatment for neovascular age-related macular degeneration (AMD) in a nationally representative longitudinal sample. DESIGN: Retrospective, longitudinal case-control study. METHODS: Using the Medicare 5% claims database, diagnoses of neovascular AMD and anti-VEGF injections of ranibizumab, bevacizumab, or pegaptanib were identified from International Classification of Diseases and Current Procedural Terminology procedure codes. Six thousand one hundred fifty-four individuals undergoing anti-VEGF treatment for neovascular AMD (total of 40 903 injections) were compared with 6154 matched controls with neovascular AMD who did not undergo anti-VEGF treatment. Propensity score matching was used to match individuals receiving anti-VEGF injections with controls. Rates of postinjection adverse outcomes (endophthalmitis, rhegmatogenous retinal detachment, retinal tear, uveitis, and vitreous hemorrhage) were analyzed by cumulative incidence and Cox proportional hazards model to control for demographic factors and ocular comorbidities. RESULTS: At the 2-year follow-up, the rates of endophthalmitis per injection (0.09%; P<.01), uveitis (0.11%; P<.01), and vitreous hemorrhage per injection (0.23%; P < .01) were significantly higher in the anti-VEGF treatment group. With Cox proportional hazards modeling, the anti-VEGF treatment group had a 102% higher risk of severe ocular complications overall and a 4% increased risk per injection, both of which were statistically significant (P<.01). CONCLUSIONS: Rates of endophthalmitis, uveitis, and vitreous hemorrhage were higher in the group treated with anti-VEGF injection than in the control group, although these nevertheless were rare in both groups. The overall risk of severe ocular complications was significantly higher in the anti-VEGF treatment group.