THE SCIENCE BEHIND OCULAR MEDICAL DEVICE EVALUATION. RELEVANT PUBLICATIONS

  1. Nakamura K, Refojo M.F, Crabtree DV, Pastor J, Leong F.L. Ocular toxicity of low-molecular-weight components of silicone and fluorosilicone oils. Invest Ophthalmol Vis Sci. 1991;32(12):3007-3020.
  1. Manzanas L, Pastor J.C, Muñoz R.. Girbes T. Intraocular Irrigating Solutions and Vitrectomy-Related Changes (in Protein, Lactic and Ascorbic Acid) in Rabbit Vitreous. Ophthalmic Res. 1992; 24:61-67.
  1. Pastor J.C, López M.I,Saornil M.A, Refojo M.F. Intravitreal silicone and fluorsilicone oils: pathologic findings in rabbit eyes. Acta Ophthalmol. 1992;70: 651-658.
  1. Pastor J.C, Zarco J.M, Del Nozal M.J, Pampliega A, Marinero P. Clinical consequences of the use of highly purified silicone oil. Comparative study of highly and less purified silicone oil. Euro J Ophthalmol 1998; 8:179-183.
  1. Pastor J.C, Puente B, Tellería J.J, Carrasco B, Sánchez H, Nocito M. Antisilicone antibodies in patients with silicone implants after retinal detachment surgery. Ophthalmic Res 2001; 33:87-90.
  1. Manzanas L, del Nozal M.J, Marcos M.A, Cordero Y, Bernal J.L, Goldschmidt P, Pastor J.C. Oral flavonoids, Chromocarb Diethylamine SALT and Cyaninosides Chloride to eliminate lipoperoxidation postvitrectomy. Exp Eye Res 2002; 74:23-28.
  1. Marcos M.A, Cordero Y, Manzanas L, del Nozal M.J, Pastor J.C. Actividad de los enzimas glutation-dependientes durante la vitrectomía. Efecto de la solución de BSS plusâ en retina. Arch Soc Esp Oftalmol 2002; 77:133-138.
  1. Sanabria M.R, Rodríguez de la Rúa E, Aragon J, Calonge M, Saornil M.A, Pastor J.C. ¿Puede aumentar el riesgo de oftalmia simpática el uso intraocular de aceite de silicona? Arch Soc Esp Oftalmol 2003; 78:39-42.
  1. Baílez C, Pastor J.C, Saornil M.A, Mendez M.C, Martín F, Rodríguez de la Rúa E, Sanabria R.M, de la Fuente M.A, Mayo A. Estudio experimental sobre la utilidad del aceite de copolímero de Silicona-Fluorsilicona (SiFo) en la cirugía vitreoretiniana [Experimental study on usefulness of silicone-fluorsilicone copolymer oil (SiFo) in vitreoretinal surgery]. Arch Soc Esp Oftalmol 2004; 79:205-212.
  1. Feitosa C, Calonge C, Pastor J.C, Bailez C, Saornil M.A, Mendez M.C. Oftalmía simpática pos-vitrectomía tras traumatismo y taponamiento con perfluorocarbonolíquido. [Sympathetic ophthalmia post-vitrectomy following trauma and perfluorocarbon liquid tamponade]. Arch Soc Esp Oftalmol 2004; 79:553-556.
  1. Pastor J.C, Rodríguez de la Rúa E, Fernández I, Nozal M.J, Jonas J. Lipophilic Substances in Intraocular Silicone Oil. Am J Ophthalmol 2007; 143:707-709.
  1. Pastor JC, Nozal MJ, Zamarron E, García MT. Solubility of triamcinolone acetonide and other anti-inflammatory drugs in silicone oil: Implications for therapeutic efficacy
  1. Pastor J.C, Coco R.M, Fernandez-Bueno I, Alonso-Alonso M.L, Medina J, Sanz-Arranz A, Rull F, Gayoso M.J, Dueñas A, Garcia-Gutierrez M.T, Gonzalez-Buendia L, Delgado-Tirado S, Abecia E, Ruiz-Miguel M, Serrano M.A, Ruiz-Moreno J.M, Srivastava GK. Acute retinal damage after using a toxic perfluoro-octane for vitreo-retinal surgery. 2017 Jun;37(6):1140-1151.
  1. Srivastava G.K, Alonso-Alonso M.L, Fernandez-Bueno I, Garcia-Gutierrez M.T, Rull F, Medina J, Coco R.M, Pastor J.C. Comparison between direct contact and extract exposure methods for PFO cytotoxicity evaluation. Scientific Reports. 2018 Jan 23. (2018) 8:1425
  1. Januschowski K, Irigoyen C, Pastor J.C, Srivastava G, Romano M, Heimann H, Stalmans P, Van Keer K, Boden K , Szurman P, Spitzer M. Retinal toxicity of medical devices used during vitreoretinal surgery: A critical overview. Ophthalmologica. 2018;240(4):236-243.
  1. Pastor J.C. [The health products scandal and the problem of perfluoro fluids]. Arch. Soc. Esp. Oftal. 2019; 94: 105-106 DOI: 10.1016/j.oftal.2018.12.012.
  1. Coco R.M, Srivastava G.K, Andrés-Iglesias C, Medina J, Rull F, Fernandez-Vega-Gonzalez A, Fernandez-Bueno I, Dueñas A, Pastor J.C. Acute retinal toxicity associated with a mixture of perfluorooctane and perfluorohexyloctane: failure of another indirect cytotoxicity analysis. Br J Ophthalmol.2019 Jan;103(1):49-54.
  1. Srivastava K.G, Andrés-Iglesias C, Coco M.R, Fernandez-Bueno I, Medina J. Garcıa-Serna J, Duenas A, Rull F, Pastor J.C. Chemical considerations regarding the H value methodology and its relation with toxicity determination. Invest Ophthalmol Vis Sci. 2019; 60:3363–3364.
  1. Srivastava G.K, Andrés-Iglesias C, Coco R.M, Fernandez-Bueno I, Medina J, García-Serna J, Dueñas A, Rull F, Pastor J.C. Chemical compounds causing severe acute toxicity in heavy liquids used for intraocular surgery. Regulatory Toxicology and Pharmacology. 2020; 110: 104527
  1. Andrés-Iglesias C., Pastor J.C. Silicone oil safety is not only a purity question. Graefes Arch Clin Exp Ophthalmol. 2021; 259: 269-270
  1. Pastor J.C. Safety of perfluorocarbon liquids cannot be the retinologist’s responsibility. Graefes Arch Clin Exp Ophthalmol. 2021; 259:1071-1072.
  1. Valentin Bravo F.J, García-Onrubia L, Andrés-Iglesias C, Valentín-Bravo E, Martín-Vallejo J, Pastor J.C. Usategui-Martín R, Pastor-Idoate S. Complications associated with the use of silicone oil in vitreoretinal surgery: A systemic review and meta-analysis. Acta Ophthalmologica 2022; 100:864-880
  1. Fernandez-Bueno I, Usategui-Martín R, Pastor J.C, Andrés-Iglesias C. Ex-Vivo method to quantifiably evaluate the staining effectiveness of anterior lens capsule dyes. Transl. Vis. Sci. Technol. 2021; 10(14):17.
  1. Srivastava GK, Kalaiselvan V, Andrés-Iglesias C, Shukla S, Saxena R, Pastor JC. Acute intraocular toxicity caused by perfluorocarbon liquids: safety control systems of medical devices. Graefes Arch Clin Exp Ophthalmol. 2022; 5:1–8.
  1. F J Valentín-Bravo, E Mateos-Álvarez, R Usategui-Martín, C Andrés-Iglesias, J C Pastor-Jimeno, S Pastor-Idoate. Artificial Intelligence and new language models in Ophthalmology: Complications of the use of silicone oil in vitreoretinal surgery. Arch Soc Esp Oftalmol (Engl Ed). 2023 May;98(5):298-303.
  1. Pastor JC. AlaOcta, the story comes to its end. Arch Soc Esp Oftalmol (Engl Ed). 2023; 98(7):365-366.
  1. Romano MR, Ferrara M, Coco-Martin RM, Rickmann A, Spitzer MS, Steel DHW, Pastor JC. INTRAOCULAR EMULSION OF SILICONE OIL (ITEMS) GRADING SYSTEM: An Evidence-Based Expert-Led Consensu. Retina. 2023; 43(8):1370-1376.
  1. Donate J, Arias-Barquet L, Ruiz-Casas D, Larra-Mateos E, Pastor JC. Reporting serious incidents in medical devices used in intraocular surgery: Proposing ideas. Arch Soc Esp Oftalmol (Engl Ed). 2023; 98(12):723-726.
  1. Cristina Andrés-Iglesias, Salvador Pastor-Idoate, Rosa M. Coco-Martin, J. Carlos Pastor. Ala®sil chemical characterization and toxicity evaluation: an example of the need for the Medical Device Regulation 2017/745. Front. Pharmacol. 2024; 4:1310463.