Safe eye surgery: non-technical aspects

The traditional training of surgeons focused exclusively on developing knowledge, clinical expertise, and technical (surgical) skills. However, analyses of the reasons for adverse events in surgery have revealed that many underlying causes originate from behavioural or non-technical aspects of performance (eg, poor communication among members of the surgical team) rather than from a lack of surgical (ie, technical) skills. Therefore, technical skills appear to be necessary but not sufficient to ensure patient safety. Paying attention to non-technical skills, such as team working, leadership, situation awareness, decision making, and communication, will increase the likelihood of maintaining high levels of error-free performance. Identification and training of non-technical skills has been developed for high-risk careers, such as civil aviation and nuclear power. Only recently, training in non-technical skills has been adopted by the surgical world and anaesthetists. Non-technical skills need to be tailored to the environment where they are used, and eye surgery has some substantial differences compared with other surgical areas, for example, high volume of surgery, use of local anaesthetics, and very sophisticated equipment. This review highlights the need for identification of the non-technical skills relevant to eye surgeons and promotion of their use in the training of eye surgeons.

Surgical checklist for cataract surgery:progress with the initiative by the Royal College of Ophthalmologists to improve patient safety

PurposeThe World Health Organisation (WHO) identified patient safety in surgery as an important public health matter and advised the adoption of a universal peri-operative surgical checklist. An adapted version of the WHO checklist has been mandatory in the National Health Service since 2010. Wrong intraocular lens (IOL) implantation is a particular safety concern in ophthalmology. The Royal College of Ophthalmologists launched a bespoke checklist for cataract surgery in 2010 to reduce the likelihood of preventable errors. We sought to ascertain the use of checklists in cataract surgery in 2012.Patients and methodsA survey of members of the Royal College of Ophthalmologists seeking views on the use of checklists in cataract surgery. Four hundred and sixty-nine completed responses were received (18% response rate).ResultsRespondents worked in England (75%), Scotland (11%), Wales (5%), Northern Ireland (2%), the Republic of Ireland (1%), and overseas (6%). Ninety-four per cent of respondents support the use of a checklist for cataract surgery and 85% say that they always use a checklist before cataract surgery. Sixty-seven per cent of cataract surgeons stated they undertake a pre-operative team brief. Thirty-six per cent use a cataract surgery checklist developed locally, 18% use the college's bespoke cataract surgery checklist, 39% use a generic surgical checklist, and 4% reported that they do not use a checklist.ConclusionNinety-three per cent of cataract surgeons responding to the questionnaire report using a surgical checklist and 67% use a team brief. However, only 54% use a checklist, which addresses the selection of the correct intraocular implant. We recommend wider adoption of checklists, which address risks relevant to cataract surgery, in particular the possibility of selection of an incorrect IOL.Eye advance online publication, 24 May 2013; doi:10.1038/eye.2013.101.

Will VEGF Trap-Eye reduce the treatment burden in neovascular age-related macular degeneration?

Evaluation of: Brown DM, Heier JS, Ciulla T et al. Primary end point results of a Phase II study of vascular endothelial growth factor trap-eye in wet age-related macular degeneration. Ophthalmology 118(6), 1089-1097 (2011); Heier JS, Boyer D, Nguyen QD et al. The 1-year results of CLEAR-IT 2, a Phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing. Ophthalmology 118(6), 1098-1106 (2011). Age-related macular degeneration is the most common cause of blindness in older adults in western countries, and is likely to become the largest cause of irreversible sight loss in the developing world. Treatments such as ranibizumab and bevacizumab that inhibit VEGF have improved visual outcomes markedly. Controlled trials and clinical experience have shown that the best outcomes are achieved when monthly treatment has been administered over 2 years. This poses a significant burden on health providers and patients. A novel inhibitor of VEGF, VEGF Trap-Eye, which allows less frequent dosing without loss of efficacy, has emerged as a potential treatment. CLEAR-IT 2 was a prospective randomized Phase II trial designed to assess the safety, tolerability and the anatomic and visual effects of repeated treatments with a range of doses of VEGF Trap-Eye. Impressive anatomic and visual improvements were noted with no safety concerns. © 2011 Expert Reviews Ltd.

An inspector's-eye view - The prospective enforcement of work-related fatality cases

This paper concerns the prospective implementation of the proposed 'corporate killing' offence. These proposals suggested that the Health and Safety Executive (HSE)-the body currently responsible for regulating work-related health and safety issues-should handle cases in which a 'corporate killing' charge is a possibility. Relatively little attention has been paid to this issue of implementation. An empirical investigation was undertaken to assess the compatibility of the HSE's methodology and enforcement philosophy with the new offence. It was found that inspectors categorize themselves as enforcers of criminal law, see enforcement action as valuable and support the new offence, but disagree over its use. They also broadly supported the HSE taking responsibility for the new offence. This suggests that 'corporate killing' may not necessarily be incompatible with the HSE's modus operandi, and there may be positive reasons forgiving the HSE this responsibility.

Efficacy and safety of travoprost 0.004%/timolol 0.5% fixed combination as transition therapy in patients previously on prostaglandin analog monotherapy

Purpose: To assess the safety and efficacy of transitioning patients whose intraocular pressure (IOP) had been insufficiently controlled on prostaglandin analog (PGA) monotherapy to treatment with travoprost 0.004%/timolol 0.5% fixed combination with benzalkonium chloride (TTFC). Methods: This prospective, multicenter, open-label, historical controlled, single-arm study transitioned patients who had primary open-angle glaucoma, pigment dispersion glaucoma, or ocular hypertension and who required further IOP reduction from PGA monotherapy to oncedaily treatment with TTFC for 12 weeks. IOP and safety (adverse events, corrected distance visual acuity, and slit-lamp biomicroscopy) were assessed at baseline, week 4, and week 12. A solicited ocular symptom survey was administered at baseline and at week 12. Patients and investigators reported their medication preference at week 12. Results: Of 65 patients enrolled, 43 had received prior travoprost therapy and 22 had received prior nontravoprost therapy (n = 18, bimatoprost; n = 4, latanoprost). In the total population, mean IOP was significantly reduced from baseline (P = 0.000009), showing a 16.8% reduction after 12 weeks of TTFC therapy. In the study subgroups, mean IOP was significantly reduced from baseline to week 12 (P = 0.0001) in the prior travoprost cohort (19.0% reduction) and in the prior nontravoprost cohort (13.1% reduction). Seven mild, ocular, treatment-related adverse events were reported. Of the ten ocular symptom questions, eight had numerically lower percentages with TTFC compared with prior PGA monotherapy and two had numerically higher percentages with TTFC (dry eye symptoms and ocular stinging/burning). At week 12, TTFC was preferred over prior therapy for 84.2% of patients (48 of 57) by the patients themselves, and for 94.7% of patients (54 of 57) by their physicians. Conclusion: When TTFC replaced PGA monotherapy in patients whose IOP had been uncontrolled, the outcome was a significant reduction in IOP and an acceptable safety and tolerability profile. Most patients and investigators preferred TTFC to prior PGA monotherapy. © 2012 Costa et al, publisher and licensee Dove Medical Press Ltd.

Safety and efficacy of fixed-combination travoprost/timolol in patients with open-angle glaucoma or ocular hypertension not controlled with timolol monotherapy

To assess the intraocular pressure (IOP)-lowering effect of travoprost 0.004%/timolol 0.5% fixed-dose combination (TRAV/TIM-FC) in patients not achieving the target IOP of ≤18 mmHg while on timolol 0.5% (TIM) monotherapy. A multicenter, prospective, open-label study (NCT01336569) was conducted in patients with open-angle glaucoma or ocular hypertension. Eligible patients were receiving TIM monotherapy with a screening/baseline IOP of 19-35 mmHg in ≥1 eye. TIM was discontinued on the baseline visit day (no washout period) and TRAV/TIM-FC was initiated and administered once daily at 8 pm for 4-6 weeks. The primary efficacy variable was mean change in IOP from TIM-treated baseline to study end, measured by Goldmann applanation tonometry. Results were analyzed by analysis of variance and paired samples t-test (5% significance). A total of 49 patients were enrolled (mean age, 63 [range, 42-82] years; 55.1% White; 73.5% women), and 45 were included in the intent-to-treat (ITT) population. Mean duration of treatment with TRAV/TIM-FC was 31 days. Mean ± standard deviation IOP reduction from baseline (TIM) to the follow-up visit (TRAV/TIM-FC) was -5.0±3.6 mmHg. IOP decreased significantly (P<0.0001) from baseline (22.1±2.6 mmHg) to study end (17.1±3.9 mmHg) in the ITT population, with a mean IOP reduction of 22.3%. Most patients (n=33/45; 73.3%) achieved IOP ≤18 mmHg. Two patients experienced a total of four adverse events (AEs), including a patient who reported one serious AE (enterorrhagia) that was considered unrelated to treatment, and a patient who reported one event each of drug-related redness, pruritus, and foreign body sensation. Most patients (n=47/49; 95.9%) reported no AEs. TRAV/TIM-FC lowered IOP in patients who were not at target IOP while receiving TIM monotherapy, with most patients achieving an IOP ≤18 mmHg with TRAV/TIM-FC. TRAV/TIM-FC was well tolerated in this population.

Vitreous Pharmacokinetics and Retinal Safety of Intravitreal Preserved Versus Non-preserved Triamcinolone Acetonide in Rabbit Eyes

Purpose: To compare the intravitreal pharmacokinetic profile of a triamcinolone acetonide formulation containing the preservative benzyl alcohol (TA-BA) versus a preservative-free triamcinolone acetonide formulation (TA-PF), and evaluate potential signs of toxicity to the retina. Methods: A total of 60 New Zealand male white rabbits, divided into two groups, were studied. In the TA-BA group, 30 rabbits received an intravitreal injection of TA-BA (4 mg/0.1ml) into the right eye. In the TA-PF group, 30 rabbits received an intravitreal injection of TA-PF (4 mg/0.1ml) into the right eye. The intravitreal drug levels were determined in 25 animals from each group by high-performance liquid chromatography (HPLC). The potential for toxicity associated with the intravitreal triamcinolone injections was evaluated in five randomly selected animals from each group by electroretinography (ERG) and by light microscopy. Results: Median intravitreal concentrations of TA-BA (mu g/ml) were 1903.1, 1213.0, 857.8, 442.0, 248.6 at 3, 7, 14, 21 and 28 days after injection. Intravitreal concentrations of TA-PF (mu g/ml) were 1032.9, 570.1, 516.6, 347.9, 102.8 at 3, 7, 14, 21 and 28 days after injection. The median intravitreal triamcinolone concentration was significantly higher in the TA-BA compared to the TA-PF group at 7 days post-injection (p < 0.05). There was no significant difference between the two groups in median triamcinolone concentration at the other time points evaluated. There was no evidence of toxic effects on the retina in either group based on ERG or histological analyses. Conclusions: Following a single intravitreal injection, the median concentration of triamcinolone acetonide is significantly higher in the TA-BA compared to the TA-PF group at 7 days post-injection. No toxic reactions in the retina were observed in either group.

La valutazione della sicurezza delle strade esistenti: Il contributo del mobile eye detector.

L’incidente stradale è la conseguenza di uno o più errori all'interno di un sistema complesso, in cui l'uomo rappresenta la principale causa d’incidentalità. Spesso ciò che può apparire a una prima analisi un errore dell’utente, in realtà può essere collegato a problemi di progettazione e gestione dell’infrastruttura. Per massimizzare i risultati nel campo della sicurezza stradale, occorre valutare il “sistema strada” in ogni suo elemento. Per raggiungere questi obiettivi le analisi di sicurezza giocano un ruolo fondamentale. Il Road Safety Review consente di individuare nel tracciato la presenza di situazioni di rischio, in modo tale da eliminarli o attenuarli prima che diano luogo ad incidenti. Il Ministero delle Infrastrutture e dei Trasporti ha emanato le "Linee guida per la gestione della sicurezza delle infrastrutture stradali". Secondo queste Linee Guida l'uomo detiene un ruolo centrale nel sistema. L'uomo deve adattare il suo comportamento, in funzione del veicolo condotto e delle condizioni ambientali. Diventa indispensabile integrare le analisi di sicurezza con il fattore uomo. Obiettivo della tesi è analizzare la sicurezza di un’infrastruttura viaria esistente integrando i risultati ottenuti dal Road Safety Review con metodologie innovative che tengano conto del comportamento degli utenti durante la guida. È stata realizzata una sperimentazione in sito che ha coinvolto un campione formato da 6 soggetti. Ognuno di essi ha percorso il tronco stradale, della SP26 "Valle del Lavino", in provincia di Bologna. La strada, richiede interventi di adeguamento e messa in sicurezza poiché risulta la terza tratta stradale a maggior costo sociale di tutta la rete provinciale. La sperimentazione ha previsto due fasi: la prima, in cui è stato condotto il Road Safety Review . La seconda, in cui ogni soggetto ha guidato lungo il tronco stradale, indossando il Mobile Eye-XG, un'innovativa strumentazione eye tracking in grado di tracciare l’occhio umano e i suoi movimenti.

La valutazione della sicurezza degli utenti deboli in prossimita degli attraversamenti pedonali: Il contributo del mobile eye detector

Lo studio effettuato si inserisce all’interno di una collaborazione tra il DICAM e la Provincia di Bologna ed ha come obiettivo l’analisi di sicurezza della SP26 “Valle del Lavino”, poichè risulta la terza tratta stradale a maggior costo sociale di tutta la rete provinciale. Il rapporto di analisi redatto a seguito del Road Safety Review ha infatti evidenziato numerosi deficit in termini di sicurezza dell’infrastruttura, tra cui gli attraversamenti pedonali. Obiettivo specifico della tesi è stato quello di valutare lo stato attuale di sicurezza degli attraversamenti pedonali presenti lungo il tracciato stradale in esame, in maniera tale da individuare, sulla base di una correlazione fra l’ubicazione degli attraversamenti stessi e il comportamento degli utenti alla guida dei veicoli, le intersezioni pedonali più gravosi, che per questo, in un piano di riqualifica della tratta stradale, richiederebbero opportuni interventi di adeguamento e messa in sicurezza. Con questa finalità è stata programmata ed eseguita una campagna di prove su strada che ha coinvolto un campione di 10 utenti, aventi determinati requisiti di base, del tutto ignari dell’obiettivo che si voleva perseguire e inesperti del tracciato di prova. La sperimentazione ha previsto l’impiego, fondamentale, di metodologie innovative, quali il V-Box e il Mobile Eye Detector, in grado di tener conto del comportamento degli utenti alla guida: il primo permette di rilevare l’andamento delle velocità dei partecipanti lungo il tracciato, il secondo restituisce il tracciamento del punto di vista del conducente alla guida. A ciascun partecipante è stato richiesto di condurre un veicolo, non di loro proprietà, per l’intero tratto della SP26 posto esame, compreso tra la progressiva 0+000, in comune di Zola Predosa, e la progressiva 19+200, in località Badia (comune di Monte San pietro), in andata e in ritorno per un complessivo di 38,4 km di tracciato da esaminare. Al conducente alla guida è stato richiesto di indossare durante tutta la guida l’occhiale Mobile Eye mentre l’auto di prova è stata dotata della strumentazione V-Box.

[Safety of treatment with tacrolimus ointment for anterior segment inflammatory diseases]

BACKGROUND: The off-label use of topical tacrolimus (Protopic) for inflammatory external eye diseases is gaining popularity. However, there are no reports on the safety profile of this new treatment option. PATIENTS AND METHODS: We treated six patients with different inflammatory eye diseases with topical tacrolimus (Protopic 0.03 %) as off-label use in addition to the conventional anti-inflammatory treatment. Patients were interviewed for side effects and serum drug concentrations were measured under steady state conditions one hour after topical application of tacrolimus ointment. RESULTS: Two patients reported a slight burning sensation immediately after application, in one patient we found a slight worsening of the dry eye problems. No patient abandoned the treatment due to side effects. Serum drug concentrations remained below the analytical threshold in all cases (< 1.5 ng/ml). CONCLUSIONS: Tacrolimus for the topical treatment of anterior segment inflammatory eye diseases is well tolerated without detectable systemic drug resorption.

Street crossing behavior in younger and older pedestrians: an eye- and head-tracking study

BACKGROUND: Crossing a street can be a very difficult task for older pedestrians. With increased age and potential cognitive decline, older people take the decision to cross a street primarily based on vehicles' distance, and not on their speed. Furthermore, older pedestrians tend to overestimate their own walking speed, and could not adapt it according to the traffic conditions. Pedestrians' behavior is often tested using virtual reality. Virtual reality presents the advantage of being safe, cost-effective, and allows using standardized test conditions. METHODS: This paper describes an observational study with older and younger adults. Street crossing behavior was investigated in 18 healthy, younger and 18 older subjects by using a virtual reality setting. The aim of the study was to measure behavioral data (such as eye and head movements) and to assess how the two age groups differ in terms of number of safe street crossings, virtual crashes, and missed street crossing opportunities. Street crossing behavior, eye and head movements, in older and younger subjects, were compared with non-parametric tests. RESULTS: The results showed that younger pedestrians behaved in a more secure manner while crossing a street, as compared to older people. The eye and head movements analysis revealed that older people looked more at the ground and less at the other side of the street to cross. CONCLUSIONS: The less secure behavior in street crossing found in older pedestrians could be explained by their reduced cognitive and visual abilities, which, in turn, resulted in difficulties in the decision-making process, especially under time pressure. Decisions to cross a street are based on the distance of the oncoming cars, rather than their speed, for both groups. Older pedestrians look more at their feet, probably because of their need of more time to plan precise stepping movement and, in turn, pay less attention to the traffic. This might help to set up guidelines for improving senior pedestrians' safety, in terms of speed limits, road design, and mixed physical-cognitive trainings.

Development of criteria and test methods for eye and face protective devices /

Mode of access: Internet.

Laws requiring helmets and eye protection for motorcylists.

National Highway Traffic Safety Administration, Washington, D.C.

Essential fatty acids for dry eye:a review

Purpose Dry eye is a common complaint often encountered in optometric practice. However, it is a difficult condition to treat as clinical signs do not always correlate with patient symptoms. Essential fatty acids (EFA), particularly omega-3 EFA, may be effective in dealing with the underlying causes. Methods A literature review was carried out on the PubMed, ScienceDirect and Ovid databases. Searches included keywords such as ‘dry eye’, ‘essential fatty acids’ and ‘nutrition’ to find articles relating to the treatment of dry eye syndrome (DES) with omega-3 EFAs. Results Omega-3 and -6 EFAs need to be consumed together within a reasonable ratio to be effective. Currently, typical diets in developed countries lack omega-3 EFA and this results in an overexposure to omega-6. Omega-3 supplementation has an anti-inflammatory effect, inhibiting creation of omega-6 prostaglandin precursors. Omega-3 EFAs also demonstrate anti-inflammatory action in the lacrimal gland preventing apoptosis of the secretory epithelial cells. Supplementation clears meibomitis, allowing a thinner, more elastic lipid layer to protect the tear film and cornea. Conclusion Dietary supplementation of omega-3 EFA has already proven to be effective in coronary heart disease and arthritis. Safety is not a concern as it works synergistically with omega-6 in the body. Evidence suggests that supplementation with omega-3 EFA may be beneficial in the treatment and prevention of DES.