Publicação
Early Clinical Outcomes of the Preserflo Microshunt Device
| Resumo: | INTRODUCTION: The purpose of this study was to assess the efficacy and safety profile of the Preserflo® Microshunt device, which is an ab externo sub-Tenon’s aqueous shunt approved for the surgical treatment of glaucoma, METHODS: Retrospective single-center observational study. Patients who underwent stan- dalone or combined phacoemulsification-Preserflo® Microshunt implantation with a minimum of 3 months of post-operative follow-up were included. Primary outcome measures included surgi- cal success defined as a ≥ 30% decrease in IOP from baseline and unmedicated IOP ≤18 mmHg. Secondary outcomes included number of hypotensive drops and adverse effects. RESULTS: Ninety-two (92) eyes from 77 patients (mean±SD age 68±18 years) were included, most of which underwent standalone surgery (n=74 eyes; 80%). Average post-operative follow-up time was 9±6 months, with over three quarters of eyes (n=70; 76%) completing at least 6 months of follow-up and a third (n=30; 33%) with at least 12 months. Mean IOP was significantly reduced from a baseline measurement of 22±5.8 mmHg throughout follow-up, with a 12-month IOP of 13.9±4.8 mmHg (p<0.0001). Mean number of medications was reduced from 2.8±0.9 to 0.5±0.9 at last follow-up (p<0.0001), with 75% of eyes remaining drop-free throughout follow-up. Absolute success at 12 months was 46% and 64% if medication was allowed (qualified). Complications included self-limited intra-operative bleeding or post-operative hyphema (total n=9; 10%), and shallow anterior chamber (n=4; 4%). No major or sight-threatening complication was recorded. CONCLUSION: Early audit of real-world data from Preserflo® use suggests this to be a safe and effective surgical option for the treatment of medically uncontrolled glaucoma. |
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| Autores principais: | Correia Barão, Rafael |
| Outros Autores: | Barata, André; José, Patrícia; Matos, Diogo; Gomes, Pedro; Peschiera, Riccardo; Abegão Pinto, Luís |
| Assunto: | Artigos Originais |
| Ano: | 2023 |
| País: | Portugal |
| Tipo de documento: | artigo |
| Tipo de acesso: | acesso aberto |
| Instituição associada: | Sociedade Portuguesa de Oftalmologia |
| Idioma: | inglês |
| Origem: | Revista Sociedade Portuguesa de Oftalmologia |
| Resumo: | INTRODUCTION: The purpose of this study was to assess the efficacy and safety profile of the Preserflo® Microshunt device, which is an ab externo sub-Tenon’s aqueous shunt approved for the surgical treatment of glaucoma, METHODS: Retrospective single-center observational study. Patients who underwent stan- dalone or combined phacoemulsification-Preserflo® Microshunt implantation with a minimum of 3 months of post-operative follow-up were included. Primary outcome measures included surgi- cal success defined as a ≥ 30% decrease in IOP from baseline and unmedicated IOP ≤18 mmHg. Secondary outcomes included number of hypotensive drops and adverse effects. RESULTS: Ninety-two (92) eyes from 77 patients (mean±SD age 68±18 years) were included, most of which underwent standalone surgery (n=74 eyes; 80%). Average post-operative follow-up time was 9±6 months, with over three quarters of eyes (n=70; 76%) completing at least 6 months of follow-up and a third (n=30; 33%) with at least 12 months. Mean IOP was significantly reduced from a baseline measurement of 22±5.8 mmHg throughout follow-up, with a 12-month IOP of 13.9±4.8 mmHg (p<0.0001). Mean number of medications was reduced from 2.8±0.9 to 0.5±0.9 at last follow-up (p<0.0001), with 75% of eyes remaining drop-free throughout follow-up. Absolute success at 12 months was 46% and 64% if medication was allowed (qualified). Complications included self-limited intra-operative bleeding or post-operative hyphema (total n=9; 10%), and shallow anterior chamber (n=4; 4%). No major or sight-threatening complication was recorded. CONCLUSION: Early audit of real-world data from Preserflo® use suggests this to be a safe and effective surgical option for the treatment of medically uncontrolled glaucoma. |
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