Testes pre-operatorios sistemicos na cirurgia de catarata ambulatorial em adultos : estudo do impacto sobre a acuidade visual pos-operatoria e sobre as complicações cirurgicas oculares

Orientadores: Rodrigo Pessoa Cavalcanti Lira, Carlos Eduardo Leite ArietaTese (doutorado) - Universidade Estadual de Campinas, Faculdade de Ciencias MedicasResumo: O objetivo deste ensaio clínico aleatório foi investigar se a rotina de testes pré-operatórios sistêmicos para facectomias reduz a ocorrência de complicações cirúrgicas oculares e estudar seu impacto na acuidade visual final. O estudo foi desenvolvido no Hospital de Clínicas da Universidade Estadual de Campinas ¿ Unicamp, Campinas, São Paulo, Brasil, entre 10 de fevereiro de 2000 e 10 de janeiro de 2001. As cirurgias de catarata foram aleatoriamente selecionadas para serem precedidas por uma rotina de testes pré-operatórios (grupo de testes rotineiros) ou não precedidas por testes rotineiros (grupo de testes seletivos). Caso o paciente foi sorteado para o grupo de testes seletivos, foi solicitado que nenhum teste pré-operatório fosse executado a menos que o paciente apresentasse um novo problema médico, ou piora de uma doença preexistente, a qual requeresse os testes independentemente da realização da cirurgia. Para pacientes sorteados para o grupo de testes rotineiros, foram solicitados: eletrocardiograma, hemograma completo e glicemia de jejum. Complicações cirúrgicas oculares, acuidade visual melhor corrigida pré e pós-operatórias foram anotadas em formulário padronizado. A amostra de 1.025 pacientes programada para ser submetida à cirurgia de catarata incluiu 513 sorteados para o grupo de testes seletivos e 512 sorteados para o grupo de testes rotineiros. Os dois grupos tiveram proporções semelhantes de operações que foram canceladas e não foram remarcadas (2% em cada grupo). A taxa cumulativa de complicações cirúrgicas oculares foi similar em ambos os grupos , 20.5% no grupo de testes rotineiros e 19.3% no grupo de testes seletivos (P = 0.624). A acuidade visual melhor corrigida pré e pós-operatória foi similar nos dois grupos (P = 0.999 na pré-operatória e P = 0.664 na pós-operatória). Os resultados deste estudo sugerem que uma rotina de testes clínicos pré-operatórios não reduz a incidência de complicações cirúrgicas oculares e não influencia na acuidade visual final. Uma conduta mais eficiente seria solicitar apenas testes pré-operatórios indicados pela história clínica ou exame físico do paciente. A adoção dessa conduta pode permitir economia ao sistema de saúde do Brasil, que financia cerca de 250.000 facectomias ao anoAbstract: The aim of this prospective randomized clinical trial was to investigate whether routine medical testing before cataract surgery reduced the rate of ocular surgical complications and to study its impact on visual acuity outcome. The study was carried out in an academic medical center in Brazil, at State University of Campinas, between 10 February 2000 and 10 January 2001. The scheduled cataract operations were randomly assigned to one of two groups: 1) to be preceded by routine medical testing (the ¿routine-testing group¿) or 2) not to be preceded by routine medical testing (the ¿selective-testing group¿). If the patient was assigned to the selective-testing group, it was requested that no preoperative testing be performed unless the patient presented with a new or worsening medical problem that would warrant medical evaluation with testing. In the case of patients assigned to the routine-testing group, three tests were requested: a 12-lead electrocardiogram, a complete blood count, and measurements of serum glucose. Ocular surgical complications, preoperative and postoperative best-corrected visual acuity were recorded on a standardized form. The sample of 1 025 patients scheduled to undergo cataract surgery was comprised of 512 assigned to the routine-testing group and of 513 assigned to the selective-testing group. The two groups had similar proportions of operations canceled and not subsequently rescheduled 2% in each group. The cumulative rate of ocular surgical complications was similar in the two groups, 20.5% in the routine-testing group and 19.3% in the selective-testing group (P = 0.624). The preoperative and the postoperative best-corrected visual acuity were similar in both groups (P = 0.999 in the former and P = 0.664 in the latter). The results of this study suggest that routine medical testing before cataract surgery did not reduce the rate of ocular surgical complications and did not influence visual acuity outcome. A more efficient approach should be only to request preoperative tests indicated by patient history or physical examination. This attitude may help our health system to save resources in its challenge of to finance 250.000 cataract surgeries each yearDoutoradoOftalmologiaDoutor em Ciências Médica

Costs and benefits of bevacizumab vial sharing for the treatment of retinal diseases

Antiangiogenic therapy has proved to be an important therapeutic tool for many retinal vascular diseases; however, its availability is limited in developing countries. This study sought to describe the bevacizumab vial sharing process and to evaluate the impact of this repackaging system on the costs incurred in a Brazilian public hospital. Method This retrospective study compared the number and costs of intravitreal antiangiogenic injections approved via court order in the first year of the study (2015) to the number and costs of the bevacizumab injections provided through the use of vial sharing in the second year of the study (2016). Vial sharing consists of the traditional process used to repackage bevacizumab; in this case, however, the drug samples used were the residual volume from the preparation of bevacizumab for oncology patients. The hospital adhered to the guidelines established by the Brazilian Health Surveillance Agency (ANVISA). Results In the first year of the study and using medication obtained through court orders, 550 intravitreal injections were performed in the ophthalmology ambulatory care center. Based on local pricing tables, the total cost of the medication was BRL$1,036,056.25 (USD$267,546.58), and the average cost of each application was BRL$1883.74 (USD$486.45). In the second year of the study, 1081 intravitreal applications were performed at the same hospital using doses obtained through bevacizumab vial sharing. The total cost was BRL$21,942.49 (USD$5663.30) and the per-unit cost was BRL$20.30, or USD$5.23 (a savings of 97.88%). Conclusion This study found that bevacizumab vial sharing led to a significant reduction in public health care costs associated with antiangiogenic treatment and increased the availability of the drug to public health care patients. These results can be extrapolated to other types of drugs and health care systems1

Macular phototoxicity after corneal cross-linking

Purpose: To assess potential vascular, structural, and functional changes to the macula in patients with keratoconus that underwent ultraviolet A (UVA)-riboflavin-mediated corneal collagen cross-linking (CXL) therapy. Patients and methods: Seventeen eyes from 17 patients of age 16 years or older with keratoconus undergoing CXL treatment were studied. The same eye served as its own control (before CXL vs after CXL). Eyes were evaluated in terms of best-corrected visual acuity (BCVA), refractive error, intraocular pressure, Amsler grid, retinography, fluorescein angiography, autofluorescence, and spectral domain optical coherence tomography (SD-OCT) prior to CXL and 7 and 30 days after treatment. Multifocal electroretinography (mfERG) was recorded prior to and 7 days after CXL. Results: Mean (SD) BCVA by logMAR chart was 0.47 (+/-0.12) pre-CXL, 0.55 (+/-0.15) 7 days post-CXL (P=0.57), and 0.46 (+/-0.10) 30 days post-CXL (P=0.87). Mean (SD) SD-OCT central macular thickness (microm) was 253.62 (+/-20.9) pre-CXL, 260.5 (+/-18.7) 7 days post-CXL (P=0.48), and 256.44 (+/-21.6) 30 days post-CXL (P=0.69). In 12 eyes, mfERG revealed a statistically significant increase (P=0.0353) in P1 latency (ms) of ring four from the pre-CXL period (39.45+/-2.05) to 7 days post-CXL (41.04+/-1.28) period. Regression analysis showed that the increase in P1 latency was correlated with the increase in central macular thickness (P=0.027). Furthermore, nine patients experienced a significant decrease in P1 amplitudes of rings 1 (P=0.0014), 2 (P=0.0029), 3 (P=0.0037), 4 (P=0.0014), and 5 (P=0.0012) from pre-CXL to 7 days post-CXL. Conclusion: In this pilot study, most of the patients exhibited slight changes in their mfERG parameters and OCT thickness, despite a lack of vascular abnormalities observed on fluorescein angiography/autofluorescence imaging, no alteration in BCVA, and no reports of symptoms. These changes could, therefore, be categorized as a mild subclinical effect of the corneal cross-linking procedure

Trimethoprim-sulfamethoxazole Versus Placebo To Reduce The Risk Of Recurrences Of Toxoplasma Gondii Retinochoroiditis: Randomized Controlled Clinical Trial.

To compare the effects of trimethoprim-sulfamethoxazole vs placebo in reducing the risk of recurrences of Toxoplasma gondii retinochoroiditis. Single-center, prospective randomized double-masked clinical trial. A total of 95 patients from Campinas, Brazil, with active recurrent Toxoplasma gondii retinochoroiditis were included. The initially active toxoplasmosis lesions were successfully treated in all cases using trimethoprim-sulfamethoxazole (800 mg/160 mg) twice daily for 45 days. Subsequently, 5 patients dropped out of the study. The remaining patients were randomized to Group 1 (trimethoprim/sulfamethoxazole tablet every 2 days) or Group 2 (identical placebo tablet every 2 days). Randomization was 1:1, was stratified by sex, and used block sizes of 4. The primary outcome was recurrent toxoplasmosis retinochoroiditis within 1 year, and the secondary outcome was a 1-year change in best-corrected visual acuity (BCVA) (ETDRS chart). The incidence of recurrent toxoplasmosis retinochoroiditis within 12 months was 0 of 46 (0%) and 6 of 47 (12.80%) in the trimethoprim-sulfamethoxazole and placebo groups, respectively (P = .026). Visual acuity improvements in the 2 groups were similar. No treatment-limiting toxicity was observed. Trimethoprim/sulfamethoxazole therapy resulted in a 100% reduction in the recurrence of Toxoplasma gondii retinochoroiditis over 1 year of treatment.157762-766.e

Pain Perception At Laser Treatment Of Peripheral Retinal Degenerations With Green And Infrared Wavelengths.

To compare the pain perception at laser treatment of peripheral retinal degenerations with green (532-nm) and infrared (810-nm) wavelengths. Prospective randomized clinical trial. Sequential patients with indications for photocoagulation of bilateral peripheral retinal degenerations were invited to participate in the study. Thirty patients (60 eyes) were enrolled in the study. Each patient had 1 eye treated with infrared laser (diode, 810-nm wavelength) and the other eye treated with green laser (frequency-doubled solid-state laser, diode-pumped, with 532-nm wavelength). The eyes were randomized to infrared or green wavelengths. The right eye was the first treated in all cases regardless of the wavelength arrangement. Immediately after photocoagulation of each eye, the patient was asked to grade pain perception according to an 11-point (ie, 0-10) numerical rating scale (NRS), with 0 meaning No pain and 10 meaning Pain as bad as you can imagine. The primary outcome was the assessment of pain. The mean grading of pain perception was 2.80 (SD 1.27; mode and median = 2) to green wavelengths and 5.07 (SD 1.36; mode = 4 and median = 5) to infrared wavelengths (P < .001). The results showed a statistically and clinically significant difference of pain perception between the 2 groups, with advantage to the green laser group.150726-730.e

Trimethoprim-sulfamethoxazole versus placebo in reducing the risk of toxoplasmic retinochoroiditis recurrences: a three-year follow-up

PURPOSE: To compare the effects of 1 year of treatment with trimethoprim/sulfamethoxazole (TMP-SMZ) vs a placebo in reducing the risk of toxoplasmic retinochoroiditis recurrences during a 3-year follow-up period. DESIGN: Randomized, double-masked clinical trial. METHODS: This cohort included 141 volunteers recruited in Campinas, Brazil. Inclusion criterion was unilateral active recurrent toxoplasmic retinochoroiditis. All volunteers were treated with 1 tablet of TMP-SMZ (160 mg/800 mg) twice daily for 45 days, and all lesions healed after this treatment. After this initial treatment, the volunteers were randomly assigned to Group 1 (1 TMP-SMZ tablet every 2 days for 311 days) or Group 2 (1 identical placebo tablet containing starch with no active ingredients every 2 days for 311 days). At the second-and third-year follow-up appointments, none of the volunteers received treatment unless a new recurrence episode had occurred. The primary outcomes were recurrent toxoplasmic retinochoroiditis within the first year of follow-up and recurrent toxoplasmic retinochoroiditis within the third year of follow-up. RESULTS: The cumulative probability of recurrence at 1, 2, and 3 years of follow-up were, respectively, 13.0% (9/69), 17.4% (12/69), and 20.3% (14/69) in the placebo group and 0% (0/72) in the TMP-SMZ group (P < .001, log-rank test). There was no case of multiple recurrences in the same individual. No treatment-limiting toxicity or side effects were observed in either group. New recurrences were more frequent among female volunteers. CONCLUSIONS: TMP-SMZ may be used safely for prophylaxis of recurrent toxoplasmic retinochoroiditis, with long-term benefits170176182FUNDAÇÃO DE AMPARO À PESQUISA DO ESTADO DE SÃO PAULO - FAPESPsem informaçã