European journal of ophthalmology · 2024
Efficacy and safety evaluation of Monoblue Dual View and Monoblue ILM View vital stains during vitrectomy surgery.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Blanckaert Gauthier, Vander Mijnsbrugge Joris, Delbecq Ann-Laure, Fils Jean-François, Jansen Joyce, Van Calster Joachim, Stalmans Peter
Аннотация
PURPOSE: To compare the staining properties of Monoblue inner limiting membrane (ILM) View and Monoblue DUAL View (study products) vital stains during vitrectomy surgery to those of ILM Blue or Membrane Blue Dual (control products).
METHODS: In this study, 105 patients were included in the Ophthalmic Clinic of the University Hospitals Leuven from September 2021 to April 2022. For prospective data collection in this study, patients were randomized between a control group (ILM Blue or Membrane Blue Dual, manufactured and commercialized by DORC®) and a study group (Monoblue ILM View or Monoblue DUAL View, manufactured and commercialized by Arcadophta®-BVI®). For retrospective data collection, patients were divided into similar surgery groups. Efficacy was analyzed using a binary subjective evaluation of the visualization of stained membranes during vitrectomy. The rate and severity of potential adverse events related to the study products were tracked, allowing both treatment groups to be compared with the corresponding control groups (ILM Blue and Membrane Blue Dual).
RESULTS: Based on the results and findings, none of the comparisons (primary outcomes) were statistically significant, showing similar efficacy of the dyes used. The study products were found to be safe in this study since no serious adverse events were reported.
CONCLUSIONS: The present findings indicate that the Monoblue ILM View and Monoblue DUAL View dyes can safely be used during vitrectomy to stain the ILM and/or epiretinal membrane (ERM) when removal is needed.
METHODS: In this study, 105 patients were included in the Ophthalmic Clinic of the University Hospitals Leuven from September 2021 to April 2022. For prospective data collection in this study, patients were randomized between a control group (ILM Blue or Membrane Blue Dual, manufactured and commercialized by DORC®) and a study group (Monoblue ILM View or Monoblue DUAL View, manufactured and commercialized by Arcadophta®-BVI®). For retrospective data collection, patients were divided into similar surgery groups. Efficacy was analyzed using a binary subjective evaluation of the visualization of stained membranes during vitrectomy. The rate and severity of potential adverse events related to the study products were tracked, allowing both treatment groups to be compared with the corresponding control groups (ILM Blue and Membrane Blue Dual).
RESULTS: Based on the results and findings, none of the comparisons (primary outcomes) were statistically significant, showing similar efficacy of the dyes used. The study products were found to be safe in this study since no serious adverse events were reported.
CONCLUSIONS: The present findings indicate that the Monoblue ILM View and Monoblue DUAL View dyes can safely be used during vitrectomy to stain the ILM and/or epiretinal membrane (ERM) when removal is needed.