Presumed phototoxicity from macular vital staining with Brilliant Blue G and Trypan Blue: A post-market surveillance study, systematic review, and synthesis of the literature.

Vital dyes are used to help visualise the retinal surface during macular surgery; however, they have been associated with phototoxicity. We sythesize and collate post-market surveillance data considered 2 of the most commonly used dyes, Brilliant Blue G and Trypan Blue. We identified 69 cases, 59 of which were from the literature and 10 from manufacturer post-market surveillance. Of 69 vitrectomies, 39 were for macular hole, 24 for epiretinal membrane, 2 for vitreomacular traction, and 4 were not specified. The incidence of dye-mediated phototoxicity is likely rare, but is not possible to quantify, due to potential reporting and publication bias favouring dissemination of unusual safety events, but conversely underreporting is possible. Additionally, phototoxicity was reported prior to the introduction of vital stains, so it can be difficult to establish whether vital staining was contributory. Prolonged surgery and repeat staining were identified as risk factors. Characteristic clinical features were macular pigmentary change with hypo- and hyper-autofluoresence, often sparing the fovea. Final visual acuity tended to be worse than preoperatively, with some cases reduced to counting fingers. A reporting template is provided to encourage complete and standardised toxicity reporting and help build a robust evidence base.