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ABSTRACT Purpose: This study aimed to evaluate the long-term safety and efficacy of neodymium-doped yttrium aluminum garnet (Nd:YAG) vitreolysis for symptomatic vitreous floaters as it remains a controversial procedure due to insufficient robust evidence in the literature for the maintenance of the results and absence of adverse effects. Methods: This is an observational extension to the previously presented prospective, randomized, double-blind clinical trial. Eight of thirteen subjects who underwent vitreolysis with YAG laser returned for a late reevaluation, 18 months after the procedure, to evaluate the efficacy and safety of the procedure. Results: All patients maintained the improvement in symptomatology noted after the procedure, with 25% showing complete improvement and a similar proportion (37.5%) reporting significant or partial improvement. Objective improvement in opacity was similar to that found at 6 months follow-up. The NEI-VFQ 25 quality of life questionnaire showed no statistically significant difference in responses between the 6th and 18th month. No adverse effects were noted on clinical examination or reported by patients. Conclusion: Vitreolysis efficacy observed at 6 months of follow-up was maintained until the eighteenth month, with all patients reporting improvement from the pre-procedure state. No late adverse effects were noted. A larger randomized clinical trial is needed to confirm the safety of the procedure.
RESUMO Objetivos: Avaliar a segurança e eficácia a longo prazo da vitreólise com Nd:YAG laser para moscas volantes sintomáticas, uma vez que permanece como um procedimento controverso devido a falta de evidência científica robusta sobre a manutenção dos resultados e ocorrência de efeitos adversos. Métodos: Este estudo é uma extensão observacional de um ensaio clínico prospectivo, randomizado, duplo cego, previamente publicado. Oito de treze pacientes que foram submetidos a vitreólise com YAG laser foram acompanhados para uma reavaliação tardia, dezoito meses após o procedimento, para avaliar a eficácia e segurança do procedimento. Resultados: Todos os pacientes mantiveram a melhora na sintomatologia notada ao final do procedimento original, com 25% dos casos apresentando melhora completa, e uma proporção semelhante (37,5%) demonstrando melhora significativa ou parcial. A melhora objetiva na opacidade foi similar ao achado no seguimento original de 6 meses. O questionário de qualidade de vida NEI-VFQ 25 não demonstrou diferença estatisticamente significativa nas respostas entre o sexto e o décimo oitavo mês de acompanhamento. Nenhum efeito adverso foi notado no exame clínico ou reportado pelos pacientes. Conclusão: A eficácia da vitreólise observada ao sexto mês do acompanhamento foi mantida até o décimo oitavo mês, com todos os pacientes notando algum grau de melhora quando comparado ao estado pré procedimento. Nenhum efeito adverso tardio foi notado. Um ensaio clínico randomizado maior é necessário para confirmar a segurança do procedimento.
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PURPOSE: This study aimed to evaluate the long-term safety and efficacy of neodymium-doped yttrium aluminum garnet (Nd:YAG) vitreolysis for symptomatic vitreous floaters as it remains a controversial procedure due to insufficient robust evidence in the literature for the maintenance of the results and absence of adverse effects. METHODS: This is an observational extension to the previously presented prospective, randomized, double-blind clinical trial. Eight of thirteen subjects who underwent vitreolysis with YAG laser returned for a late reevaluation, 18 months after the procedure, to evaluate the efficacy and safety of the procedure. RESULTS: All patients maintained the improvement in symptomatology noted after the procedure, with 25% showing complete improvement and a similar proportion (37.5%) reporting significant or partial improvement. Objective improvement in opacity was similar to that found at 6 months follow-up. The NEI-VFQ 25 quality of life questionnaire showed no statistically significant difference in responses between the 6th and 18th month. No adverse effects were noted on clinical examination or reported by patients. CONCLUSION: Vitreolysis efficacy observed at 6 months of follow-up was maintained until the eighteenth month, with all patients reporting improvement from the pre-procedure state. No late adverse effects were noted. A larger randomized clinical trial is needed to confirm the safety of the procedure.
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BACKGROUND: Mineralocorticoid receptor antagonists (MRAs) are widely used for chronic central serous chorioretinopathy (cCSCR), but their effectiveness remains unclear. This research was conducted to evaluate the efficacy of this drugs for cCSCR. METHODS: This is a review of randomized clinical trials (RCT) comparing MRAs to placebo in adults with cCSCR, using the effects of MRAs on best-corrected visual acuity (BCVA) and adverse events as primary outcomes and the effects of MRAs on anatomical parameters as secondary outcomes: central subfield thickness (CST), subretinal fluid height (SFH) and central choroidal thickness (CCT). Our all-language online search included Medline (via PubMed), Central, Embase, Lilacs, Ibecs, and RCT registers platforms, as late as May 2021. We used the Cochrane risk-of-bias tool (version 2) to assess the methodological quality of each study and synthesized the results in meta-analyses using a random-effects model. RESULTS: The search identified 302 records, five of which were eligible, totaling 225 cCSCR patients (aged 45-62 years; M/F ratio 3.1:1) treated for 1 to 12 months with spironolactone (50 mg/day) or eplerenone (50 mg/day) vs. placebo. Moderate-certainty evidence suggests MRAs result in little to no improvement in BCVA compared to placebo (SMD 0.22; 95% CI - 0.04 to 0.48; studies = 5; comparisons = 6; participants = 218; I2 = 0%). Very low-certainty evidence suggests that, when compared to placebo, MRAs have a very uncertain impact on adverse effects (no meta-analysis was performed), and CST (MD 18.1; 95% CI - 113.04 to 76.84; participants = 145; studies = 2; I2 = 68%). MRAs also result in little to no difference in SFH (SMD - 0.35; 95% CI - 0.95 to 0.26; studies = 5; comparisons = 6; participants = 221; I2 = 76%; moderate certainty) and CCT (MD - 21.23; 95% CI - 64.69 to 22.24; participants = 206; studies = 4; comparisons = 5; I2 = 85%; low certainty). CONCLUSION: MRAs have little to no effect on BCVA. Evidence for adverse events and CST is very uncertain. MRAs also have little to no effect on SFH and CCT. These findings should be considered when prescribing MRAs for cCSCR. This research was previous registration in the PROSPERO platform (CRD42020182601).
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BACKGROUND: Vitreous floaters are a common and inconvenient phenomena. This study aims to examine the efficacy and safety in treating vitreous floaters using Nd:YAG laser vitreolysis. METHODS: In this prospective double-blinded randomized clinical trial 24 eyes of twenty-four patients were randomized into intervention with YAG laser vitreolysis and control groups. Primary outcomes were visual disturbance on a 10-point scale, qualitative changes in a 4-level scale, contrast sensitivity measured with the Pelli-Robson table and the National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25). Secondary results included objective change in vitreous opacities, best-corrected visual acuity (BCVA), variation in intraocular pressure (IOP) and other adverse events. RESULTS: Twenty-one patients (21 eyes; 5 male, 16 female) were enrolled in this study (mean age 62 ± 7.9 years), three were lost during follow-up. In the YAG laser group, the 10-point visual disturbance score improved a mean of 4.7 points (p < 0.001) compared to the control group that improved 2.1 (p = 0.09). The YAG laser group reported greater subjectively symptomatic improvement (77%) than controls (25%). NEI VFQ-25 revealed improved general vision (75.8 versus 59.2; p = 0.037) and in mental health at 6 months (84.3 versus 70.3; p = 0.048). There was no significant difference in contrast sensitivity (p = 0.848) and in IOP (p = 0.505). No differences in adverse events between groups were identified. CONCLUSION: Vitreolysis with Nd:YAG laser improves visual results in patients with symptomatic vitreous floaters, without adverse events considered clinically relevant. Other trials with a larger number of participants are required to corroborate these results.
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Terapia por Láser , Láseres de Estado Sólido , Femenino , Humanos , Láseres de Estado Sólido/uso terapéutico , Masculino , Estudios Prospectivos , Agudeza Visual , VitrectomíaRESUMEN
Objetivo: Os autores apresentam dois casos raros e ilustrativos de tumor vasoproliferativo, idiopático presumido da retina associado à hemorragia vítrea recidivante, em duas pacientes jovens e sadias. Método: Dois olhos de duas pacientes foram avaliados por meio do exame de fundoscopia, retinografia, angiofluoresceinografia e ultra-sonografia. Resultados: Nos dois casos relatados, o tumor vascular retiniano foi unilateral, solitário e apresentou evidências ultra-sonográficas de adesão vítrea. São discutidos os diagnósticos diferenciais da doença e alternativas de tratamento com crioterapia, fotocoagulação e vitrectomia. Conclusão: Os autores ressaltam a importância do reconhecimento do tumor vasoproliferativo idiopático da retina nos casos de hemorragia vítrea recidivante.