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

Vital Paulino Costa1, Hamilton Moreira2, Mauricio Della Paolera3, Maria Rosa Bet de Moraes Silva41Universidade Estadual de Campinas – UNICAMP, São Paulo, 2Universidade Federal do Paraná, Curitiba, 3Santa Casa de Misericórdia de São Paulo, São Paulo, 4Faculdade de Medicina de Botucatu, UNESP, BrazilPurpose: 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 once-daily 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.Keywords: fixed combination, glaucoma, intraocular pressure, prostaglandin analog, timolol, travopros

Social inclusion for visually impaired: experience and results from Assis

PURPOSES: To establish the visually impaired resource class users profile in the city of Assis - SP, to estimate the visually impaired employment percentage and to compare employment rate with age, gender, deficiency type and causing disease between two periods:1984 - 1996 and 1997 - 2009. METHODS: Retrospective review of both medical and school records from visually impaired individuals attending visually impaired resource class in Assis - SP between 1984 and 2009. This time period was divided into two intervals: 1984 - 1996 (G1) and 1997 - 2009 (G2). Collected data included demographic features and diseases, type of visual impairment (blindness or low vision), education, optic aids, attendance to visually impaired resource class and employment rate. Employment rate was associated with age, gender, type of visual impaiment and causing disease between both study time intervals. RESULTS: A total of 149 visually impaired individuals were identified - 61.07% male, 38.9% female, 82.5% white, and 17.4% non-white. Mean age was 18 years. Of the 149 visually impaired, 63.75% had low vision and 36.24% were blind. In decreasing order, the more frequent conditions leading to visual impairment were toxoplasmosis retinochoroiditis (17.40%), congenital optic atrophy (9.39%), high hyperopia (8.72%), pigmentary retinosis and high myopia (with 6.71% each) and congenital glaucoma and congenital cataract (with 6.04% each). Attendance to visually impaired resource class was good by over 50% of the patients. Of the individuals >14 years-old, 44.7% and 12.3% were regularly employed during 1984 - 1996 and 1997 - 2009 periods, respectively. Employment rate only correlated with age (individuals with higher mean age were most frequently employed) and there was not correlation with demographic characteristics, deficiency type and causing diseases. CONCLUSIONS: The main characteristics of the individuals attending the visually impaired resource class are: male, white, with low vision and ocular toxoplasmosis. Nearly half of the individuals older than 14 years-old (44.7%) were regularly employed up to 1996, suggesting that the joint effort of ophthalmologists and teachers helps the social inclusion of these patients. Employment rate dropped over 1997 - 2009 period, and the rate of retirees increased.OBJETIVOS: Traçar o perfil do usuário da Sala de Recursos para Deficiente Visual na cidade de Assis - SP, avaliar a porcentagem de deficientes visuais empregados e comparar o emprego com idade, gênero, tipo de deficiência e doença causadora da deficiência, entre dois períodos: de 1984 a 1996 e de 1997 a 2009. MÉTODOS: Foi realizado estudo retrospectivo dos prontuários médicos e da ficha escolar dos portadores de deficiência visual que frequentaram a Sala de Recursos para Deficiente Visual, no período de 1984 a 2009 na cidade de Assis - SP, divididos em dois períodos de 1984 a 1996 (G1) e de 1997 a 2009 (G2). Analisaram-se dados demográficos, a doença que provocou a baixa visão, o tipo de deficiência visual (cegueira ou baixa visão), escolaridade, recursos ópticos, frequência à Sala de Recursos para Deficiente Visual e taxa de emprego. Foi feita associação da taxa de emprego com: idade, gênero, raça/cor, tipo de deficiência e doença nos dois diferentes períodos. RESULTADOS: Foram encontrados 149 deficientes visuais sendo: 61,07% homens, 38,9% mulheres, 82,5% brancos e 17,4% não brancos e a mediana da idade foi de 18 anos. Dos 149 deficientes visuais, 63,75% eram portadores de baixa visão e 36,24% portadores de cegueira. As principais doenças que levaram à deficiência visual dos 149 pacientes foram em ordem decrescente: retinocoroidite por toxoplasmose (17,40%), atrofia óptica congênita (12,10%), alta hipermetropia (8,72%), retinose pigmentar e alta miopia (6,71% cada uma) e glaucoma congênito e catarata congênita (6,04% cada uma). A frequência à Sala de Recursos para Deficiente Visual foi boa em mais de 50% dos pacientes. Estavam trabalhando regularmente 44,7% e 12,3% dos maiores de 14 anos respectivamente nos períodos de 1984 - 1996 e de 1997 - 2009. Não houve diferença entre os dois períodos quanto às características demográficas, tipo de deficiência e doenças, havendo correlação da taxa de emprego apenas com a idade (pacientes com média de idade maior apresentavam maior porcentagem de emprego). CONCLUSÕES: Os deficientes visuais eram na maioria homens, brancos, portadores de baixa visão e portadores de toxoplasmose ocular. Quase metade (44,7%) dos pacientes com mais de 14 anos encontrava-se trabalhando regularmente até 1996 sugerindo que esforços conjuntos de oftalmologistas e educadores auxilia na inclusão social destes pacientes. A taxa de emprego caiu no período de 1997 a 2009 e a de aposentados aumentou.UNESP Faculdade de Medicina de Botucatu Departamento de Oftalmologia, Otorrinolaringologia e Cirurgia de Cabeça e PescoçoUniversidade Estadual de CampinasUniversidade Federal de São Paulo (UNIFESP) Departamento de OftalmologiaUniversidade de Santo AmaroInstituto de Oftalmologia de AssisUNIFESP, Depto. de OftalmologiaSciEL

O Ensino da Oftalmologia

Submitted by Guilherme Lemeszenski ([email protected]) on 2013-08-22T18:58:26Z No. of bitstreams: 1 S0034-72802009000300001.pdf: 52278 bytes, checksum: 78ae156c34032e789351a7fd4cd9d194 (MD5)Made available in DSpace on 2013-08-22T18:58:26Z (GMT). No. of bitstreams: 1 S0034-72802009000300001.pdf: 52278 bytes, checksum: 78ae156c34032e789351a7fd4cd9d194 (MD5) Previous issue date: 2009-06-01Made available in DSpace on 2013-09-30T19:54:07Z (GMT). No. of bitstreams: 2 S0034-72802009000300001.pdf: 52278 bytes, checksum: 78ae156c34032e789351a7fd4cd9d194 (MD5) S0034-72802009000300001.pdf.txt: 7235 bytes, checksum: 45226a582d038571ab8fe173ce91b31b (MD5) Previous issue date: 2009-06-01Submitted by Vitor Silverio Rodrigues ([email protected]) on 2014-05-20T15:14:05Z No. of bitstreams: 2 S0034-72802009000300001.pdf: 52278 bytes, checksum: 78ae156c34032e789351a7fd4cd9d194 (MD5) S0034-72802009000300001.pdf.txt: 7235 bytes, checksum: 45226a582d038571ab8fe173ce91b31b (MD5)Made available in DSpace on 2014-05-20T15:14:05Z (GMT). No. of bitstreams: 2 S0034-72802009000300001.pdf: 52278 bytes, checksum: 78ae156c34032e789351a7fd4cd9d194 (MD5) S0034-72802009000300001.pdf.txt: 7235 bytes, checksum: 45226a582d038571ab8fe173ce91b31b (MD5) Previous issue date: 2009-06-01UNESP Faculdade de Medicina de Botucatu Departamento de Oftalmologia, Otorrinolaringologia e Cirurgia de Cabeça e PescoçoUNESP Faculdade de Medicina de Botucatu Departamento de Oftalmologia, Otorrinolaringologia e Cirurgia de Cabeça e Pescoç

Toxicidade da mitomicina C ao endotélio da córnea de coelhos

Purpose: To evaluate corneal endothelium alterations after applying mitomycin C to the sclera using transmission and scanning electron microscopy, correlating alterations with time, concentration, and evaluation methods. Methods: The corneal endothelium of both eyes of 32 albino rabbits was evaluated and distributed into four groups of 8. Mitomycin C was applied under a scleral flap in the right eye for 5 minutes. Mitomycin C concentrations were 0.5 mg/ml for G1 and G2 and 0.2 mg/ml for G3 and G4. Examinations were performed 15 days after application to G1 and G3, and 30 days after application to G2 and G4. Four cornea in each group were prepared for transmission electron microscopy and four for scanning electron microscopy. Left eyes of all animals were used as controls. Results: Transmission electron microscopy showed corneal endothelium alterations in all groups: rarefied cytoplasm, dilation and fragmentation of rough endoplasmic reticulum cisternae, Golgi apparatus with cisternal dilation, reduced vacuoles, and irregularities of internal membrane more noticeable in G1 and G2. Scanning electron microscopy revealed alterations in all groups except G1: changes in the shape and size of cells and longer filopodial projections. Conclusions: 1-Corneal endothelium alterations were seen at both 0.5 and 0.2 mg/ml concentrations and at 15 and 30 days after mytomicin C application; 2 - Alterations were more intense with higher mytomicin C concentration by transmission electron but not by scanning electron microscopy; 3 - The alterations correlated with time by scanning electron microscopy but not by transmission electron microscopy

Efeito da mitomicina c no epitélio ciliar estudo experimental em coelhos com microscopia eletrônica de varredura e de transmissão

Purpose: To evaluate and correlate in the rabbit the possible changes caused by mitomycin C under the scleral flap in the ciliary epithelium with transmission electron microscopy (TEM) and scanning electron microscopy (SEM). Methods: The eyes of 32 albino rabbits were studied and divided in 4 experimental groups. The right eye (RE) was intended for the experimental groups and the left eye (LE) for the controls. Group I (G1) was formed by 8 eyes that received 0,5 mg/ml of mitomycin C under the scleral flap and were examined after 15 days. Group II (G2) differed from G1 only in the time of the exam, after 30 days. Group III (G3) was formed by 8 eyes that received 0,2 mg/ml of mitomycin C under the scleral flap and were examined after 15 days. Group IV (G4) differed from group 3 just in the time of the exam, after 30 days. In each eye the internal ciliary epithelium were examined with TEM. Results: The following changes in the internal ciliary epithelium were observed in groups G2, G3, and G4 with TEM: discontinuous and irregular basement membrane, more irregular and electron-dense nucleous, enlargement among interdigitation, edematous mitochondria and myelin figures. These alterations were not found in all the animals of the groups. Group G 1 did not present alterations. Roughness in groups G 1, G2, G3 and G4 were observed with SEM. In groups G 1 and G2 continuity solutions were also observed. Conclusion: Mitomycin C in 0,2 mg/ml and 0,5 mg/ml concentrations caused changes in the internal ciliary epithelium 15 and 30 days after, with TEM and SEM. There was no correlation between dosage, time and with TEM and SEM

Estudo do comportamento da PIO de 24 horas e frequência de glaucoma em pacientes com síndrome da apnéia obstrutiva do sono

Purpose: To determine the frequency of glaucoma and evaluate the behavior of 24-hour intraocular pressure in patients with the obstructive sleep apnea syndrome (OSAS). Methods: Eleven consecutive patients with OSAS, diagnosed by polysonography, were avaliated in a cross-sectional study. Demographic data were analyzed: age, sex, race/color, weight, height and associated diseases. The patients were submitted to complete ophthalmologic examination, including the visual field, as well as to 24-hour intra-ocular pressure (IOP) evaluation by an applanation tonometer at 9h, 12h, 15h, 18h, 24h and 6h in the lying and sitting positions. The diagnostic criterion for glaucoma was alteration of the visual field (VF) compatible with glaucoma and one or more of the following alterations: cup-disc ratio >= 0.7, hemorrhage, wedge-shaped defect, bayonet-shaped vessels, Hoyt's sign, asymmetry > than 0.2 between cup/disc ratio of the eyes. The angle should be opened without alterations. Results: 9 (82%) of 11 patients showed glaucoma or were suspected to have glaucoma, 9% of which exhibited normal tension glaucoma and 73% were suspected to have glaucoma for presenting alterations in the optic nerve or ocular hypertension. The mean for the IOP values of the 11 patients was observed to be the highest at 6 o'clock, when they were lying down. Variations of IOP >= 5 mmHg occurred in 7 (64%) of the patients, and variations of up to 14 mmHg and IOP peaks of up to 32 mmHg were observed. Conclusion: OSAS may be an important risk factor for the development of glaucoma, particularly that of normal tension glaucoma. Patients with OSAS must be referred to an ophthalmologist and those professionals must be attentive to the association of sleep disorders in patients with open-angle glaucoma.Objetivo: Determinar a frequência de glaucoma e avaliar o comportamento da pressão intraocular (PIO) de 24 horas em pacientes portadores da síndrome da apnéia obstrutiva do sono (SAOS). Métodos: Foi realizado estudo transversal em 11 pacientes consecutivos portadores de SAOS diagnosticados por polissonografia. Foram analisados dados demográficos: idade, sexo, raça/cor, peso, altura e doenças associadas. Os pacientes foram submetidos à avaliação oftalmológica completa que incluiu campo visual e também avaliação da pressão intraocular (PIO) de 24 horas com tonômetro de aplanação às 9h, 12h, 15h, 18h, 24h e 6h deitado e sentado. O critério para diagnóstico de glaucoma foi alteração de campo visual (CV) compatível com glaucoma e uma ou mais das seguintes alterações: relação escavação disco ≥ 0,7, hemorragia, defeito em cunha, vaso em baioneta, sinal de Hoyt, assimetria > que 0,2 entre as escavações dos dois olhos. O ângulo devia ser aberto sem alterações. Resultados: 9 (82%) de 11 pacientes apresentaram glaucoma ou suspeita de glaucoma, sendo 9% glaucoma de pressão normal e 73% suspeita de glaucoma por apresentarem alterações do nervo óptico ou hipertensão ocular. A média dos valores de PIO dos 11 pacientes apresentou-se mais elevada às 6 horas quando os pacientes estavam deitados. Ocorreram flutuações de PIO ≥ 5 mmHg em 7 (64%) dos pacientes sendo que ocorreram flutuações de até 14 mmHg e picos de PIO de até 32 mmHg. Conclusão: A SAOS pode ser um fator de risco importante para o esenvolvimento de glaucoma principalmente de pressão normal. Pacientes com SAOS devem ser referidos para o oftalmologista e os oftalmologistas devem estar atentos para a associação de distúrbios do sono em pacientes com glaucoma de ângulo aberto

Avaliação ultra-estrutural dos efeitos tóxicos da mitomicina C no epitélio ciliar de olhos de coelhos normais com e sem tratamento hipotensor ocular prévio

OBJETIVO: Avaliar o epitélio ciliar interno (ECI) do corpo ciliar após aplicação de mitomicina C (MMC) sob retalho escleral, em animais tratados com dois tipos de inibidores da produção do humor aquoso. MÉTODOS: Foram estudados ambos os olhos de 16 coelhos divididos em 4 grupos experimentais. Foi realizado retalho escleral em todos os olhos dos animais, mas apenas os olhos direitos (OD) receberam MMC. No grupo 1 (G1) não houve tratamento prévio. Nos grupos G2 e G4 foi administrada acetazolamida e nos grupos G3 e G4 maleato de timolol. O ECI foi examinado à microscopia eletrônica de transmissão (MET). Os olhos esquerdos formaram os grupos controle. RESULTADOS: em todos os grupos exceto no G1 OE, foram observadas: retração das células e/ou alargamento entre invaginações, mitocôndrias com rarefação, vesículas claras e corpos densos. A membrana limitante interna estava espessada, descontínua ou descolada em todos grupos exceto G1 OE e G2 OE. Foi observada liberação de material citoplasmático apenas nos grupos tratados com inibidores da produção de humor aquoso. CONCLUSÕES: 1- MMC, acetazolamida e maleato de timolol causaram alterações morfológicas no epitélio ciliar mesmo usados isoladamente. 2- A associação MMC e acetazolamida causou mais alterações do que a acetazolamida isoladamente, mas não mais do que a MMC isoladamente. 3- Nas demais associações as alterações foram semelhantes.PURPOSE: To evaluate the effects of mitomycin C (MMC) on the internal ciliary epithelium (ICE) of the ciliary body of animals treated with two differents aqueous humor supressants. METHODS: The eyes of sixteen Norfolk albino rabbits divided into four experimental groups were studied. The right eyes (RE) of the four groups received 0.1 ml of MMC (0.5 mg/ml) under the scleral flap. The left eyes (LE) was the control group. Group 1 (G1) did not have any other treatment. To Group 2 (G2) and Group 4 (G4) acetazolamide was administered. To Group (G3) and Group 4 (G4) timolol maleate was administered. ICE was examined by transmission electron microscopy (TEM). RESULTS: The following aspects were observed in all groups, except in G1 LE: cell shrinkage and/or enlargement of intercellular spaces, rarefied mitochondria, clear vesicular structures and electron-dense bodies. The internal limitant membrane showed to be thickened, discontinued and separeted in all groups, except in G1 LE and G2 LE. Discharge of cytoplasmatic material was observed only in the groups treated with aqueous humor supressants. CONCLUSIONS: 1) MMC, acetazolamide and timolol maleate caused morphological alterations in the ciliary epithelium even when used alone. 2) The combination of MMC and acetazolamide caused more alterations than did isolated acetazolamide, but not more than MMC alone. 3) For the other combinations the alterations were similar