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 02-abr-2025