RT info:eu-repo/semantics/article
T1 Ex-Vivo Method to Quantifiably Evaluate the Staining Effectiveness of Anterior Lens Capsule Dyes
A1 Fernández Bueno, Iván
A1 Usategui Martín, Ricardo
A1 Pastor Jimeno, José Carlos
A1 Andrés-Iglesias, Cristina
AB Purpose: High frequency of cataracts and the requirements of new European Unionregulations for medical devices require the availability of preclinical models toadequatelyevaluateanteriorlens capsuledyes beforetheir usein patients.Herein, wedescribeanexvivomethodtoquantifiablyevaluatethemacroscopicandmicroscopicstainingeffectivenessofanteriorlenscapsuledyesusingporcineeyes.Methods: Commercially available trypan blue–based products or physiological salinesolution(negativecontrol)wasinjectedintoporcineeyes.Anteriorpoleandlens(afterextraction) were macroscopically photographed, and the images were quantitativelyanalyzed. Lenses were histologically processed, and the staining intensity microscopi-callywassemiquantified.Results: Macroscopic evaluation of the anterior pole revealed bluish staining of theanteriorcapsule;however,thiscoloringcannotbemacroscopicallydiscernedafterlensextraction.Quantitativeimageanalysesshowedsignificant(P < 0.01)stainingofthelenscapsule compared to the negative control, but not significant (P > 0.05) between theproductstested.Quantitativeanalysisofdyingonlensimagescouldnotbeperformed.Microscopicsemiquantificationofthecapsulestainingintensityallowsustoappreciatedifferencesbetweenproducts.Conclusions: The described method is a quick and useful tool for macroscopic evalu-ation by surgeons to choose an anterior capsule staining for use during everydaysurgeries, and a more specific microscopic evaluation also allows us to determine theeffectivenessandusefulnessoftheseproducts.Translational Relevance: This method satisfies preclinical effectiveness evaluationsrequiredbyEuropeanUnionregulationsandcomplementsthesafetyandtoxicityevalu-ationsthatnewproductsmustguaranteebeforetheyenterthemarketandareusedinclinicalpractice.
SN 2164-2591
YR 2021
FD 2021
LK https://uvadoc.uva.es/handle/10324/71461
UL https://uvadoc.uva.es/handle/10324/71461
LA eng
NO Translational Vision Science & Technology 2021;10:17
NO Producción Científica
DS UVaDOC
RD 27-dic-2024