External Validation of a Model to Predict Postoperative Globe Axial Length in Children After Bilateral Cataract Surgery.

PURPOSE: To perform the external validation of a model to predict postoperative axial length (AL) in children over 2 years of age who were undergoing bilateral cataract surgery with primary intraocular lens (IOL) implantation. DESIGN: Validation study using a retrospective case series. METHODS: Using a population different from the one that created the model, but with the same characteristics regarding age, bilateral cataract, primary IOL implantation, and follow-up assessment, AL was estimated. The AL values estimated by the model were compared with the AL measured in the follow-ups. RESULTS: In all, 55 eyes of 30 children were selected for this study; in 5 children with bilateral cataracts, only 1 eye was included. The median age at the time of surgery was 5.01 years. Follow-up AL measurements were obtained for 179 visits. The median age at the final follow-up visit was 10.15 years. The median AL measured and estimated by the model in all visits were 22.37 mm and 22.16 mm, respectively (Pearson coefficient: 0.9534; Lin correlation: 0.9258). In the Bland-Altman analysis, the 95% limit of agreement between the 2 methods (measured and estimated AL) was 0.71 to -1.19. In 3 eyes (1.68%) with AL shorter than 21.2 mm, the difference was >0.71, and in 9 eyes with AL longer than 22.5 (5.03%), it was less than -1.19. The median AL measured and estimated at the final visit were 22.69 mm and 22.43 mm, respectively. CONCLUSION: Our previously developed prediction model for globe AL growth demonstrated good external validity by accurately predicting measured AL changes with growth in the validation cohort.

Probiotics for the treatment of depression and anxiety: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND & AIM: Probiotics in the gut have been suggested to have a beneficial effect on anxiety response and depressive disorder. Hence we conducted a systematic review and meta-analysis to summarize the effects of probiotics associated with or without pharmacological or psychological therapies in patients with depressive and/or anxiety symptoms or disorders. METHODS: We conducted searches of MEDLINE, EMBASE, CENTRAL, PsycINFO, CINAHL, ProQuest, LILACS, and Web of Science up to February 2020 to identify randomized controlled trials (RCTs) investigating the efficacy of probiotics associated with or without pharmacological or psychological therapies for patient-important outcomes including relief of depressive, anxiety and stress symptoms, cognitive functions, adverse events and quality of life. We used the GRADE approach to rate the overall certainty of the evidence by outcome. The protocol of the systematic review was registered with PROPSERO and published under the number CRD4202016329. RESULTS: 16 RCTs including 1,125 patients proved eligible. Results suggested a significant improvement in using Beck Depression Index (MD, -3.20 [95% CI, -5.91 to -0.49], p = 0.02; I2 = 21%, p = 0.28) for depression symptoms and State-Trait Anxiety Inventory (STAI) (MD, -6.88 [95% CI, -12.35 to -1.41], p = 0.01; I2 = 24%, p = 0.25) for anxiety with overall certainty in evidence rated as moderate and low, respectively. However, Depression Scale (DASS-Depression) (MD, 2.01 [95% CI, -0.80 to 4.82], p = 0.16; I2 = 0%, p = 0.62), Montgomery-Asberg Depression Rating Scale (MADRAS) (MD, -2,41 [95% CI, -10,55 to 5,72], p = 0,56; I2 = 87%, p = 0,006), Anxiety scale (DASS-Anxiety) (MD, 0.49 [95% CI, -4.05 to 5.02], p = 0.83; I2 = 74%, p = 0.05), and Stress Scale (DASS-Stress) (MD, 0.84 [95% CI, -2.64 to 4.33], p = 0.64; I2 = 34%, p = 0.22) showed no significant decrease in the relief of depression, anxiety and stress symptoms of probiotics compared to placebo with overall certainty in evidence rated as very low for all outcomes. We also found no differences in the Beck Anxiety Index (BAI) (MD, -3.21 [95% CI, -6.50 to 0.08], p = 0.06; I2 = 0%, p = 0.88) with overall certainty in evidence rated as low. Results suggested a non-statistically significantly effect of probiotics in the adverse events outcomes. CONCLUSIONS: The current review suggests that probiotics may improve symptoms of depression and anxiety in clinical patients. However, given the limitations in the included studies, RCTs with long-term follow-up and large sample sizes are needed.

Biological Therapy in Noninfectious Pediatric Uveitis: A Systematic Review.

PURPOSE: Noninfectious pediatric uveitis is a potentially blinding disease often associated with systemic conditions. In cases of chronic anterior uveitis without adequate response to steroids and immunosuppressants, biological response modifiers would be viable therapeutic options. Still, evidence is lacking on the safety of the long-term use of these drugs in children. Therefore, this study aimed to evaluate the efficacy and safety of biological therapy to treat noninfectious pediatric uveitis. METHODS: A systematic review was performed to identify original studies involving biological therapy for children diagnosed with noninfectious uveitis. Quality of evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) classification system. RESULTS: Nine studies involving 526 children were eligible. Adalimumab was superior to placebo in reducing inflammatory activity (risk ratio (RR) 3.21 [95% confidence interval (CI) 1.65-6.27]; P = 0.0006; I2 = 0%) and steroid use (RR 2.27 [95% CI 1.03-4.99]; P = 0.04; I2 = 0%, low-certainty evidence). There was no difference between adalimumab and placebo in the occurrence of systemic adverse events (RR 2.51 [95% CI 0.74-8.54]; P = 0.14; I2 = 48%) and local events (RR 1.15 [95% CI 0.46-2.88]; P= 0.76; I2 = 1%). There was no difference between adalimumab and infliximab in response to treatment (RR 1.18 [95% CI 0.69-2.03]; P= 0.55; I2 = 91%, very low-certainty evidence) and in the occurrence of adverse effects (RR 0.84 [95% CI 0.41-1.73]; P= 0.64; I2 = 18%, low-certainty evidence). CONCLUSION: There is low to very-low evidence that biological therapy is effective and safe in managing noninfectious pediatric uveitis. Future large randomized trials may provide more substantial evidence to confirm these results.

Probing for congenital nasolacrimal duct obstruction: a systematic review and meta-analysis of randomized clinical trials.

PURPOSE: Lacrimal probing is the treatment of choice for congenital nasolacrimal duct obstruction that does not have a spontaneous resolution; however, there is no consensus about the best time for probing and if it is superior to other therapies. The present study aimed to evaluate the effectiveness of lacrimal probing compared with other treatments/no intervention to treat congenital nasolacrimal duct obstruction. METHODS: A systematic review of literature in PubMed, EMBASE, CENTRAL, clinicaltrials.gov, and LILACS databases up to December 2019 was performed. Randomized clinical trials that enrolled children diagnosed with congenital nasolacrimal duct obstruction and undergoing lacrimal probing were considered. Data extraction and a risk of bias assessment were conducted independently and in duplicate. The overall quality of evidence for each outcome was conducted using the Grading of Recommendations, Assessment, Development, and Evaluation classification system. RESULTS: Four randomized clinical trials involving 423 participants were eligible. No statistically significant differences were observed in resolution rates between early probing and observation/late probing (two studies; risk ratio 1.00 [95% confidence interval 0.76-1.33]; p=0.99; low certainty evidence). One study reported better resolution rates with bicanalicular silicone stent intubation compared with late probing in the complex congenital nasolacrimal duct obstruction cases subgroup (risk ratio 0.56 [95% confidence interval 0.34-0.92]; p=0.02; moderate certainty evidence). CONCLUSIONS: Low certainty evidence suggests that early probing has the same success rate as late probing. Evidence of moderate certainty suggests that late probing has a lower success rate than bicanalicular silastic intubation in patients with complex congenital nasolacrimal duct obstructione.

The ROPScore as a Screening Algorithm for Predicting Retinopathy of Prematurity in a Brazilian Population.

OBJECTIVES: To evaluate the accuracy of the ROPScore algorithm as a predictor of retinopathy of prematurity (ROP). METHODS: A prospective cohort of 220 preterm infants with a birth weight ≤1500 g and/or gestational age ≤32 weeks was included. The ROPScore was determined in the sixth week of life in 181 infants who then survived until a corrected gestational age of 45 weeks. The sensitivity, specificity, and positive (PPV) and negative predictive values (NPV) of the algorithm were analyzed. RESULTS: ROP was found in 17.6% of the preterm infants. The sensitivity of this test for any stage of ROP was 87.5%, while that for severe ROP was 95.4% (21/22 cases). The PPV and NPV were 59.6% and 97%, respectively, for any stage of ROP and 44.7% and 99.25%, respectively, for severe ROP. The ROPScore could therefore hypothetically reduce the number of ophthalmologic examinations required to detect ROP by 71.8%. CONCLUSION: The ROPScore is a useful screening tool for ROP and may optimize examinations and especially the identification of severe ROP.

The Ropscore as a screening algorithm for predicting retinopathy of prematurity in a brazilian population

OBJECTIVES: To evaluate the accuracy of the ROPScore algorithm as a predictor of retinopathy of prematurity (ROP). METHODS: A prospective cohort of 220 preterm infants with a birth weight ≤1500 g and/or gestational age ≤32 weeks was included. The ROPScore was determined in the sixth week of life in 181 infants who then survived until a corrected gestational age of 45 weeks. The sensitivity, specificity, and positive (PPV) and negative predictive values (NPV) of the algorithm were analyzed. RESULTS: ROP was found in 17.6% of the preterm infants. The sensitivity of this test for any stage of ROP was 87.5%, while that for severe ROP was 95.4% (21/22 cases). The PPV and NPV were 59.6% and 97%, respectively, for any stage of ROP and 44.7% and 99.25%, respectively, for severe ROP. The ROPScore could therefore hypothetically reduce the number of ophthalmologic examinations required to detect ROP by 71.8%. CONCLUSION: The ROPScore is a useful screening tool for ROP and may optimize examinations and especially the identification of severe ROP.

Endoftalmite fúngica endógena bilateral secundária a pielonefrite obstrutiva / Bilateral endogenous fungal endophthalmitis secondary obstructive pyelonephritis

RESUMO Os autores relatam um caso de endoftalmite fúngica endógena bilateral ocorrida após nefrostomia descompressiva decorrente de pielonefrite obstrutiva secundária a nefrolitíase tratada, inicialmente, com injeção intravítrea de voriconazol (100 ìg/0.1 ml) porém evoluiu sem resposta terapêutica sendo necessária a vitrectomia posterior (23G).

ABSTRACT The authors report a case of bilateral endogenous fungal endophthalmitis occurred after decompression nephrostomy due to secondary obstructive pyelonephritis the treated nephrolithiasis initially with intravitreal voriconazole (100 mg / 0.1 ml) but evolved without therapeutic response requiring the posterior vitrectomy (23G).

Differences between the real and the desired worlds in the results of clinical trials.

OBJECTIVE: We refer to the effectiveness (known as pragmatic or real world) and efficacy (known as explanatory or desired or ideal world) of interventions. However, these terms seem to be randomly chosen by investigators who design clinical trials and do not always reflect the true purpose of the study. A pragmatic-explanatory continuum indicator summary tool was thus developed with the aim of identifying the characteristics of clinical trials that distinguish between effectiveness and efficacy issues. We verified whether clinical trials used the criteria proposed by the indicator summary tool, and we categorized these clinical trials according to a new classification. METHOD: A systematic survey of randomized clinical trials was performed. We added a score ranging from 0 (more efficacious) to 10 (more effective) to each domain of the indicator summary tool and proposed the following classifications: high efficacy (<25), moderate efficacy (25-50), moderate effectiveness (51-75), and high effectiveness (<75). RESULTS: A total of 844 randomized trials were analyzed. No analyzed trials used the criteria proposed by the indicator summary tool. Approximately 44% of the trials were classified as having moderate effectiveness, and 43.82% were classified as having moderate efficacy. CONCLUSIONS: Most clinical trials used the term "efficacy" to illustrate the application of results in clinical practice, but the majority of those were classified as having moderate effectiveness according to our proposed score. The classification based on the 0-100 score is still highly subjective and can be easily misunderstood in all domains based on each investigator's own experiences and knowledge.

Differences between the real and the desired worlds in the results of clinical trials

OBJECTIVE:We refer to the effectiveness (known as pragmatic or real world) and efficacy (known as explanatory or desired or ideal world) of interventions. However, these terms seem to be randomly chosen by investigators who design clinical trials and do not always reflect the true purpose of the study. A pragmatic-explanatory continuum indicator summary tool was thus developed with the aim of identifying the characteristics of clinical trials that distinguish between effectiveness and efficacy issues. We verified whether clinical trials used the criteria proposed by the indicator summary tool, and we categorized these clinical trials according to a new classification.METHOD:A systematic survey of randomized clinical trials was performed. We added a score ranging from 0 (more efficacious) to 10 (more effective) to each domain of the indicator summary tool and proposed the following classifications: high efficacy (<25), moderate efficacy (25-50), moderate effectiveness (51-75), and high effectiveness (<75).RESULTS:A total of 844 randomized trials were analyzed. No analyzed trials used the criteria proposed by the indicator summary tool. Approximately 44% of the trials were classified as having moderate effectiveness, and 43.82% were classified as having moderate efficacy.CONCLUSIONS:Most clinical trials used the term “efficacy” to illustrate the application of results in clinical practice, but the majority of those were classified as having moderate effectiveness according to our proposed score. The classification based on the 0-100 score is still highly subjective and can be easily misunderstood in all domains based on each investigator’s own experiences and knowledge.

Systematic reviews showed insufficient evidence for clinical practice in 2004: what about in 2011? The next appeal for the evidence-based medicine age.

RATIONALE AND AIM: The aims of the Cochrane systematic reviews are to make readily available and up-to-date information for clinical practice, offering consistent evidence and straightforward recommendations. In 2004, we evaluated the conclusions from Cochrane systematic reviews of randomized controlled trials in terms of their recommendations for clinical practice and found that 47.83% of them had insufficient evidence for use in clinical practice. We proposed to reanalyze the reviews to evaluate whether this percentage had significantly decreased. METHODS: A cross-sectional study of systematic reviews published in the Cochrane Library (Issue 7, 2011) was conducted. We randomly selected reviews across all 52 Cochrane Collaborative Review Groups. RESULTS: We analyzed 1128 completed systematic reviews. Of these, 45.30% concluded that the interventions studied were likely to be beneficial, of which only 2.04% recommended no further research. In total, 45.04% of the reviews reported that the evidence did not support either benefit or harm, of which 0.8% did not recommend further studies and 44.24% recommended additional studies; the latter has decreased from our previous study with a difference of 3.59%. CONCLUSION: Only a small number of the Cochrane collaboration's systematic reviews support clinical interventions with no need for additional research. A larger number of high-quality randomized clinical trials are necessary to change the 'insufficient evidence' scenario for clinical practice illustrated by the Cochrane database. It is recommended that we should produce higher-quality primary studies in active collaboration and consultation with global scholars and societies so that this can represent a major component of methodological advance in this context.

Avaliação do sistema sanguíneo Duffy como fator de risco para a toxoplasmose ocular / Evaluation of Duffy blood system as a risk factor for ocular toxoplasmosis

Objetivos: Este estudo visou a determinar as frequências dos fenótipos Duffy em pacientes com toxoplasmose ocular, comparando-as com as frequências de indivíduos sem a doença, bem como avaliar o sistema sanguíneo Duffy como fator de risco para a toxoplasmose ocular. Local: Hospital das Clínicas da Faculdade de Medicina de Botucatu-UNESP, Setor de Uveítes. Casuística e Métodos: Foram estudados 134 indivíduos de ambos os sexos, divididos em dois grupos: Grupo com Toxoplasmose Ocular (GT), composto por 68 pacientes com o diagnóstico da doença e Grupo de Controle (GC), composto por 66 indivíduos sem a doença. Para estabelecer ou excluir o diagnóstico de toxoplasmose ocular, os pacientes e indivíduos estudados passaram por avaliação clínica e laboratorial. Resultados: Os resultados obtidos determinaram as seguintes frequências fenotípicas: no grupo GT, FY(a+b+) em 53,57 por cento dos pacientes; Fy(a+b-) em 21,43 por cento; Fy(a-b+) em 21,43 por cento e Fy(a-b-) em 3,57 por cento dos pacientes estudados.No grupo CG as frequências foram: Fy(a+b+), 25,40 por cento; Fy(a+b-), 19,05 por cento; Fy(a-b+), 44,44 por cento e Fy(a-b-), 11,11 por cento. Houve diferença significativa nas frequências dos fenótipos entre os grupos GT e GC e também entre os fenótipos dentro de cada grupo. Os resultados da avaliação de risco mostraram que os indivíduos com o fenótipo FY(a+b+) têm cerca de quatro vezes mais chance (OR: 4,366) de desenvolver toxoplasmose ocular que o fenótipo Fy(a-b+) e aproximadamente seis vezes mais chance (OR: 6,578) que o fenótipo Fy(a-b-). A Fração Etiológica demonstrou que os indivíduos com o fenótipo Fy(a+b+) têm um risco adicional de cerca de 50 por cento (FE: 0,5031) de desenvolver a retinocoroidite toxoplásmica em relação à população de indivíduos Fy(a+b-). O estudo deonstrou ainda que a população de indivíduos com o fenótipo Fy(a+b+) tem um risco adicional de cerca de 46 por cento (FE: 0,4597) de desenvolver a toxoplasmose ocular em relação ao restante da população estudada. Conclusão: Estes resultados permitem concluir que o sistema sanguíneo de Duffy é um fator de risco para a toxoplasmose ocular, o que abre novas possibilidades de pesquisa em relação a esta doença.

Corpo estranho intra-ocular migratório - relato de caso / Migratory intra-ocular foreign body - a case report

Objetivo: Relatar caso de migração de corpo estranho intra-ocular. Local: Serviço de Oftalmologia do Hospital das Clínicas da Faculdade de Medicina de Botucatu - UNESP. Método: Paciente masculino vítima de trauma perfurante com corpo estranho intra-ocular (CEIO), submetido à propedêutica oftalmológica para diagnóstico e localização de CEIO. Resultado: CEIO migrou da porção posterior do cristalino para a retina, onde ficou encravado. Foi retirado cirurgicamente. Conclusão: Ressaltamos a importância da propedêutica ocular adequada e repetida em CEIO e enfatizamos a relevância do conhecimento da possibilidade de migração do CEIO e do papel da ultrassonografia no diagnóstico, acompanhamento e avaliação das lesões.

Carcinoma da glândula lacrimal - relato de caso / Carcinoma of Lacrimal Gland - Case report

Objetivo: relatar caso de paciente jovem do sexo masculino com neoplasia maligna da glândula lacrimal, discutindo quadro clínico e conduta. Local: Serviço de Onco-oftalmologia e Órbita da Faculdade de Medicina de Botucatu (SP) - UNESP. Método: Apresentamos o caso e ressaltamos os sinais e sintomas não característicos de tumor maligno da glândula lacrimal e destacamos a importância da investigação complementar nesta condição. Resultado: Após biópsia da lesão chegou-se ao diagnóstico de carcinoma da glândula lacrimal, que foi tratado por abordagem cirúrgica conservadora. Conclusão: Tumor maligno da glândula lacrimal pode ter quadro clínico que simule outras lesões orbitárias ou da glândula sendo, ainda, controverso o tratamento cirúrgico diante desta grave doença.

Retinopatia diabética: estudo ultraestrutural e morfométrico do epitélio pigmentar de ratos normais e aloxônicos / Diabetic retinopathy: ultrastructural and morphometric study of the pigmentary epithelium of normal and aloxanix rats

Estudo de 20 ratos da raça Wistar, normais e diabéticos, distribuídos em quatro grupos experimentais. O diabetes foi induzido pela droga Aloxana i.v. na dose de 42 mg/kg com o objetivo principal de analisar o epitélio pigmentar da retina. Em todos os animais foram avaliados parâmetros clínicos, bioquímicos e morfológicos. Isto foi feito comparando-se ratos normais e diabéticos de diferentes idades e estágios da doença, visando a caracterizar os grupos experimentais durante o acompanhamento, a estudar a ultraestrutura do epitélio pigmentar da retina e a mensurar as invaginaçöes da membrana plasmática basal, por meio de dois métodos morfométricos distintos.

Toxoplasmose ocular - análese de 100 pacientes tratados na Faculdade de Medicina de Botucatu / Ocular toxoplasmosis - review of 100 patients treated at Botucatu Faculty of Medicine

Com o objetivo de conhecer as características da toxoplasmose ocular em nossa regiäo, analisamos os últimos 100 portadores de toxoplasmose ocular tratados no Ambulatório de Uvea da Faculdade de Medicina de Botucatu - SP. Observamos que 60,0 por cento dos pacientes foram do sexo masculino, a maioria com idade de 20 a 30 anos, apresentando queixa de diminuiçäo da acuidade visual. Seis deles tiveram toxoplasmose sistêmica previamente e 2 tinham história familiar de toxoplasmose. Os precipitados ceráticos e o flare aquoso foram os achados biomicroscópios mais freqüentes. As placas se localizam mais freqüentemente na regiäo temporal e nasal superior. No hemograma, leucocitose com linfocitose e eosinofilia foram os achados mais freqüentes. A reaçäo de Imunofluorescência Indireta foi negativa em 28,3 por cento dos casos, apresentou títulos baixos de IgG na maioria deles e IgM positivo em 2 pacientes. O tratamento näo foi capaz de prevenir a cegueira em 26,7 por cento dos casos, o que reforça a necessidade de medidas preventivas, visando diminuir os casos de cegueira por toxoplasmose.