Effectiveness of monthly and fortnightly anti-VEGF treatments for age-related macular degeneration / Efetividade de tratamentos anti-VEGF mensais e quinzenais para a degeneração macular relacionada à idade

ABSTRACT Purpose: To study the efficacy and safety of treatments with ranibizumab and bevacizumab for exudative age-related macular degeneration. Methods: A parallel randomized clinical trial was conducted to compare the efficacy and safety of three regimens (bevacizumab every month, bevacizumab every 2 weeks, and ranibizumab every month), followed by as-needed retreatments, for 1 year, in previously untreated individuals with age-related macular degeneration. The primary outcome was change in visual acuity and in central macular thickness after 1 year of follow-up. Subjects were assigned randomly to one of the three groups in a 1:1:1 ratio, and investigators and examiners were blinded to the randomization results. Results: We included 15 patients in each group. After 1 year of follow-up, we found statistically significant improvements in visual acuity and central macular thickness reduction in all groups. However, we found no statistically significant differences between the three groups. Conclusions: The bi-weekly follow-up was effective and we found no significant differences in efficacy or safety between the treatments with ranibizumab and bevacizumab.

RESUMO Objetivo: Estudar a eficácia e segurança dos tratamentos com ranibizumabe e bevacizumabe para a degeneração macular relacionada à idade exsudativa. Métodos: Ensaio clínico paralelo randomizado foi conduzido para comparar a eficácia e segurança de três regimes (bevacizumabe a cada mês, bevacizumabe a cada 2 semanas e ranibizumabe todos os meses), seguidos por retratamentos conforme necessidade, durante 1 ano, em indivíduos previamente não tratados com degeneração macular relacionada à idade. O desfecho primário foi alteração na acuidade visual e na espessura macular central após um ano de seguimento. Os indivíduos foram designados aleatoriamente para um dos 3 grupos em uma proporção de 1:1:1, e os investigadores e examinadores foram mascarados para os resultados da randomização. Resultados: Foram incluídos 15 pacientes em cada grupo. Após um ano de seguimento, encontramos melhorias estatisticamente significativas na acuidade visual e na redução da espessura macular central em todos os grupos. No entanto, não encontramos diferenças estatisticamente significativas entre os 3 grupos. Conclusões: O seguimento quinzenal foi eficaz e não encontramos diferenças significativas na eficácia ou segurança entre os tratamentos com bevacizumabe e ranibizumabe.

Effectiveness of monthly and fortnightly anti-VEGF treatments for age-related macular degeneration.

PURPOSE: To study the efficacy and safety of treatments with ranibizumab and bevacizumab for exudative age-related macular degeneration. METHODS: A parallel randomized clinical trial was conducted to compare the efficacy and safety of three regimens (bevacizumab every month, bevacizumab every 2 weeks, and ranibizumab every month), followed by as-needed retreatments, for 1 year, in previously untreated individuals with age-related macular degeneration. The primary outcome was change in visual acuity and in central macular thickness after 1 year of follow-up. Subjects were assigned randomly to one of the three groups in a 1:1:1 ratio, and investigators and examiners were blinded to the randomization results. RESULTS: We included 15 patients in each group. After 1 year of follow-up, we found statistically significant improvements in visual acuity and central macular thickness reduction in all groups. However, we found no statistically significant differences between the three groups. CONCLUSIONS: The bi-weekly follow-up was effective and we found no significant differences in efficacy or safety between the treatments with ranibizumab and bevacizumab.

Comparative efficacy of two different topical povidone-iodine 5% regimens in reducing conjunctival bacterial flora: A randomized parallel double-masked clinical trial.

INTRODUCTION: The increasing prevalence of multi-resistant bacteria is a major public health concern. Infections acquired during ophthalmic surgery are devastating. The purpose of the current study is to compare the proportion of eyes with negative bacterial cultures on all tested media after 1 versus 3 sequential drops of povidone-iodine (PI) 5% into the inferior conjunctival fornix. METHODS: Patients were randomly assigned to receive 1 (PI group) drop (at time 28 minutes) or 3 (PI plus group) sequential drops (at time 0, 20 minutes and 28 minutes) of PI 5% into the inferior conjunctival sac of one randomly selected eye. A swab culture was obtained from the inferior conjunctival fornix 5 minutes before and 30 minutes after time 0. Central corneal thickness (CCT) was measured shortly before time 0 and shortly after time 30. Conjunctival swabs were incubated aerobically in enriched Thioglycolate liquid medium (meat broth) and in three solid culture media (chocolate agar, trypticase soy agar with 5% sheep blood, and Sabouraud agar). RESULTS: There was no significant difference in the proportion of negative cultures after intervention between groups (p = 0.1638). Also in the PI group (n = 59), the proportion of eyes with negative cultures after PI (79.7%) did not differ significantly from baseline (76.3%; p = 0.7539). However in the PI plus group (n = 61), the proportion of eyes with all negative cultures after PI (85.3%) was significantly higher than before PI (70.5%) (p = 0.0177). There was no significant difference in mean CCT before and after the intervention in both groups. CONCLUSION: Instillation of 3 sequential drops of PI was associated with a significant increase in the proportion of eyes with all negative cultures, while instillation of a single drop of PI was not associated with a significant increase in the proportion of negative cultures. Further study is warranted to determine whether the difference between the PI administration regimens is also associated with differences in the rates of postoperative ocular infections.

Composition of intraocular foreign bodies: experimental study of ultrasonographic presentation.

PURPOSE: To investigate the reliability of ultrasound in determining the size and identify the sonographic features and artifacts generated by intraocular foreign bodies of different materials. METHODS: Experimental study using 36 enucleated porcine eyes. Fragments of nine different compositions (wood, glass, plastic, cardboard, iron, aluminum, lead, powder and concrete) and similar dimensions (4 mm) were implanted via scleral incision into the vitreous cavity of 36 porcine eyes, four eyes were used for each material. Ultrasound examination was performed in all eyes using the contact technique, conductive gel and 10-MHz transducer (EZScan, Sonomed). RESULTS: Considering the material fragments of gunpowder, lead, concrete, aluminum, wood and glass, the size determined by ultrasound was considered statistically similar to the actual size. The material iron presented ultrasound-determined dimension statistically smaller than its actual size. Cardboard and plastic materials showed ultrasound-determined measurements far greater than the actual. All fragments of intraocular foreign bodies demonstrated hyper-reflective interfaces, irrespective of their composition. Whereas the artifacts generated by different materials, it was found that the materials iron, aluminum and lead showed reverberation of great extent. The material wood showed no reverberation. The length of the reverberation artifact for the materials iron, glass, aluminum and cardboard was lower when compared to other materials. All materials presented posterior shadowing artifact, with the exception of aluminum. CONCLUSION: Ultrasonography was considered a reliable technique to determine the size of intraocular foreign bodies in pigs, with little influence caused by its composition. Ultrasound artifacts generated were considered material-dependent and can assist the examiner to identify the nature of a foreign body of unknown etiology. Ultrasonography aided the surgeon to identify, locate and measure the intraocular foreign body, directing appropriate surgical planning.

Composition of intraocular foreign bodies: experimental study of ultrasonographic presentation / Composição de corpos estranhos intraoculares: estudo experimental da apresentação ultrassonográfica

PURPOSE: To investigate the reliability of ultrasound in determining the size and identify the sonographic features and artifacts generated by intraocular foreign bodies of different materials. METHODS: Experimental study using 36 enucleated porcine eyes. Fragments of nine different compositions (wood, glass, plastic, cardboard, iron, aluminum, lead, powder and concrete) and similar dimensions (4 mm) were implanted via scleral incision into the vitreous cavity of 36 porcine eyes, four eyes were used for each material. Ultrasound examination was performed in all eyes using the contact technique, conductive gel and 10-MHz transducer (EZScan, Sonomed). RESULTS: Considering the material fragments of gunpowder, lead, concrete, aluminum, wood and glass, the size determined by ultrasound was considered statistically similar to the actual size. The material iron presented ultrasound-determined dimension statistically smaller than its actual size. Cardboard and plastic materials showed ultrasound-determined measurements far greater than the actual. All fragments of intraocular foreign bodies demonstrated hyper-reflective interfaces, irrespective of their composition. Whereas the artifacts generated by different materials, it was found that the materials iron, aluminum and lead showed reverberation of great extent. The material wood showed no reverberation. The length of the reverberation artifact for the materials iron, glass, aluminum and cardboard was lower when compared to other materials. All materials presented posterior shadowing artifact, with the exception of aluminum. CONCLUSION: Ultrasonography was considered a reliable technique to determine the size of intraocular foreign bodies in pigs, with little influence caused by its composition. Ultrasound artifacts generated were considered material-dependent and can assist the examiner to identify the nature of a foreign body of unknown etiology. Ultrasonography aided the surgeon to identify, locate and measure the intraocular foreign body, directing appropriate surgical planning.

OBJETIVO: Investigar a confiabilidade da ultrassonografia em determinar a dimensão e identificar as características ultrassonográficas e os artefatos gerados por corpos estranhos intraoculares de materiais diferentes. MÉTODOS: Estudo experimental, utilizando 36 olhos enucleados de origem suína. Fragmentos de nove diferentes composições (madeira, vidro, plástico, papelão, ferro, alumínio, chumbo, pólvora e concreto) e de dimensões similares (4 mm) foram implantados cirurgicamente via incisão escleral na cavidade vítrea de 36 olhos porcinos, 4 olhos para cada tipo de material. O exame ultrassonográfico foi realizado em todos os olhos utilizando-se a técnica de contato, gel condutor e transdutor de 10 MHz (EZScan, Sonomed). RESULTADOS: Considerando os fragmentos dos materiais pólvora, chumbo, concreto, alumínio, madeira e vidro, a dimensão determinada pela ultrassonografia foi considerada estatisticamente similar à dimensão real. O material ferro apresentou dimensão ultrassonográfica estatisticamente menor que sua dimensão real. Papelão e plástico demonstraram medida maior que o real. Todos fragmentos de corpos estranhos intraoculares demonstraram interfaces hiper-refletivas, independentemente da sua composição. Considerando os artefatos gerados pelos diferentes materiais, verificou-se que os materiais ferro, alumínio e chumbo apresentaram reverberação de grande extensão. O material madeira não apresentou reverberação. O comprimento do artefato de reverberação dos materiais ferro, vidro, alumínio e papelão foi menor quando comparado aos outros materiais. Todos materiais apresentaram artefato de sombreamento posterior, com exceção do alumínio. CONCLUSÃO: A ultrassonografia foi considerada uma técnica confiável para determinar a dimensão de corpos estranhos intraoculares em porcinos, com pouca influência causada pela sua composição. Artefatos gerados à ultrassonografia foram considerados material-dependentes e podem auxiliar o examinador a identificar a natureza de um corpo estranho de etiologia desconhecida. O auxílio diagnóstico nestes casos permite ao cirurgião identificar, localizar e dimensionar o corpo estranho intraocular, orientando um planejamento cirúrgico adequado.