June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Acute retinal toxic damage by AlaOcta® a liquid perfluorooctane liquid used in retinal detachment surgery. Clinical picture and functional consequences
Author Affiliations & Notes
  • Jose-Carlos Pastor
    IOBA-Campus Miguel Delibes, University of Valladolid, Valladolid, Spain
    Ophthalmology, Hospital Clinico Universitario, Valladolid, Valladolid, Spain
  • Rosa M Coco
    IOBA-Campus Miguel Delibes, University of Valladolid, Valladolid, Spain
    University of Valladolid, Valladolid, Spain
  • Ivan Fernandez-Bueno
    IOBA-Campus Miguel Delibes, University of Valladolid, Valladolid, Spain
    Oftared, Madrid, Spain
  • Maria L Alonso-Alonso
    IOBA-Campus Miguel Delibes, University of Valladolid, Valladolid, Spain
  • Medina Jesus
    Departamento de Cristalografia y Mineralogia. University of Valladolid, Valladolid, Spain
    University of Valladolid, Valladolid, Spain
  • Fernando Rull
    Departamento de Cristalografia y Mineralogia. University of Valladolid, Valladolid, Spain
    University of Valladolid, Valladolid, Spain
  • Manuel J Gayoso
    Departamento de Biologia Celular, Valladolid, Castilla y Leon, Spain
    University of Valladolid, Valladolid, Spain
  • Antonio Dueñas
    University of Valladolid, Valladolid, Spain
  • Maria T García-Gutierrez
    IOBA-Campus Miguel Delibes, University of Valladolid, Valladolid, Spain
  • Lucia Gonzalez-Buendia
    IOBA-Campus Miguel Delibes, University of Valladolid, Valladolid, Spain
    University of Valladolid, Valladolid, Spain
  • Santiago Delgado-Tirado
    IOBA-Campus Miguel Delibes, University of Valladolid, Valladolid, Spain
    University of Valladolid, Valladolid, Spain
  • Emilio Abecia
    Hospital Miguel Servet. Zaragoza, Zaragoza, Spain
    Oftared, Madrid, Spain
  • Miguel Ruiz-Miguel
    Hospital Donostia, San Sebastian, Spain
    Oftared, Madrid, Spain
  • Miguel A Serrano
    Hospital Universitario de Canarias, Las Palmas, Spain
  • Jose Maria Ruiz-Moreno
    University of Castilla la Mancha, Albacete, Spain
    Oftared, Madrid, Spain
  • Girish Kumar Srivastava
    IOBA-Campus Miguel Delibes, University of Valladolid, Valladolid, Spain
    Oftared, Madrid, Spain
  • Footnotes
    Commercial Relationships   Jose-Carlos Pastor, None; Rosa Coco, None; Ivan Fernandez-Bueno, None; Maria L Alonso-Alonso, None; Medina Jesus, None; Fernando Rull, None; Manuel Gayoso, None; Antonio Dueñas, None; Maria T García-Gutierrez, None; Lucia Gonzalez-Buendia, None; Santiago Delgado-Tirado, None; Emilio Abecia, None; Miguel Ruiz-Miguel, None; Miguel Serrano, None; Jose Maria Ruiz-Moreno, None; Girish Srivastava, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 4252. doi:
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      Jose-Carlos Pastor, Rosa M Coco, Ivan Fernandez-Bueno, Maria L Alonso-Alonso, Medina Jesus, Fernando Rull, Manuel J Gayoso, Antonio Dueñas, Maria T García-Gutierrez, Lucia Gonzalez-Buendia, Santiago Delgado-Tirado, Emilio Abecia, Miguel Ruiz-Miguel, Miguel A Serrano, Jose Maria Ruiz-Moreno, Girish Kumar Srivastava; Acute retinal toxic damage by AlaOcta® a liquid perfluorooctane liquid used in retinal detachment surgery. Clinical picture and functional consequences. Invest. Ophthalmol. Vis. Sci. 2017;58(8):4252.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : In a series of patients with non-complicated retinal detachments, AlaOcta® a liquid perfluoro-octane was used. Due to the inability of current ISO 10993 protocols to detect some potential impurities in sanitary products, this surgical tool caused severe cases of retinal acute toxicity. The purpose of this work is to describe the clinical picture and functional consequences.

Methods : We analyzed the cases reported by 28 Spanish Ophthalmology Centers to the National Agency for Medicine and Sanitary Products. A panel of 6 expert retinologists analyzed all available information from patients charts and clinical retinal images (retinographies and OCT). In some cases additional information could be obtained.

Results : 117 cases were notified, and 96 were clearly related to the intraoperative use of AlaOcta®. Initial picture, in the most severe cases, was acute retinal necrosis (n= 38) and vascular (vein and artery) occlusion (n= 33) in the 24 h of post-operative period followed by retinal atrophy (n= 46) (OCT demonstrated), optic nerve atrophy (n= 82), macular holes formation (n= 16) and proliferative vitreoretinopathy (PVR) development (n= 13). After 3 months of follow up, 53 eyes had no light perception and 97 eyes were below measurable visual acuity.

Conclusions : Although AlaOcta® was checked for cytotoxicity by a certified and specialized German company, protocols and methodology accepted by the European Union (ISO protocols) failed at detecting the presence of highly toxic compounds. These current protocols for intraocular sanitary products should be revised.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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