Stéphan Tobalem1, Andreas Weinberger2, Martina Kropp3, Ariane Malcles2, Christian Jonescu-Cuypers3, Georges Souteyrand2, Gabriele Thumann3. 1. Department of Ophthalmology, University Hospitals of Geneva, Rue Alcide-Jentzer 22, 1205 Geneva, Switzerland; Experimental Ophthalmology, University of Geneva, Avenue de la Roseraie 64, 1205 Geneva, Switzerland. Electronic address: stephantobalem@gmail.com. 2. Department of Ophthalmology, University Hospitals of Geneva, Rue Alcide-Jentzer 22, 1205 Geneva, Switzerland. 3. Department of Ophthalmology, University Hospitals of Geneva, Rue Alcide-Jentzer 22, 1205 Geneva, Switzerland; Experimental Ophthalmology, University of Geneva, Avenue de la Roseraie 64, 1205 Geneva, Switzerland.
Abstract
PURPOSE: Analyze charts to determine patient outcomes operated with the perfluorooctane Ala® Octa compared to patient outcomes operated with perfluorodecaline F-Decalin. DESIGN: Retrospective, consecutive, comparative, interventional case series. METHODS: Forty-eight eyes that underwent vitrectomy with Ala® Octa were compared to 29 eyes that underwent vitrectomy with F-Decalin. Two experienced surgeons performed vitrectomies at the Geneva University Eye Clinic. Visual acuity before, at 8 and 24 weeks after surgery was documented and SD-OCT images were analyzed for abnormalities. RESULTS: Two patients experienced severe retinal toxicity including one with severe vision loss. However, no statistical difference in visual acuity was observed between Ala® Octa and F-Decalin. Analysis of SD-OCT images showed differences in occurrence of several abnormalities: IS-OS alterations were found in 60.4% of Ala® Octa- and in 10.3% of F-Decalin-treated eyes, retinal atrophic areas in 41.7% of Ala® Octa and in none of F-Decalin, ILM contraction in 58.4% of Ala® Octa and in none of F-Decalin, inner retina cystic alterations in 58.3% in Ala® Octa and in 17.2% of F-Decalin, outer retina cystic alterations in 39.6% of Ala® Octa and in 13.8% of F-Decalin, retinal holes in 14,6% of Ala® Octa and in none of F-Decalin, outer retinal inclusions in 20,8% of Ala® Octa and in 3.45% of F-Decalin. CONCLUSION: Ala® Octa has caused significantly more toxic damage than F-Decalin. Special consideration should be given to develop a central European control agency for medical devices and to reevaluate safety procedures currently accepted by the EU and ISO standard for intraocular surgery.
PURPOSE: Analyze charts to determine patient outcomes operated with the perfluorooctaneAla® Octa compared to patient outcomes operated with perfluorodecaline F-Decalin. DESIGN: Retrospective, consecutive, comparative, interventional case series. METHODS: Forty-eight eyes that underwent vitrectomy with Ala® Octa were compared to 29 eyes that underwent vitrectomy with F-Decalin. Two experienced surgeons performed vitrectomies at the Geneva University Eye Clinic. Visual acuity before, at 8 and 24 weeks after surgery was documented and SD-OCT images were analyzed for abnormalities. RESULTS: Two patients experienced severe retinal toxicity including one with severe vision loss. However, no statistical difference in visual acuity was observed between Ala® Octa and F-Decalin. Analysis of SD-OCT images showed differences in occurrence of several abnormalities: IS-OS alterations were found in 60.4% of Ala® Octa- and in 10.3% of F-Decalin-treated eyes, retinal atrophic areas in 41.7% of Ala® Octa and in none of F-Decalin, ILM contraction in 58.4% of Ala® Octa and in none of F-Decalin, inner retina cystic alterations in 58.3% in Ala® Octa and in 17.2% of F-Decalin, outer retina cystic alterations in 39.6% of Ala® Octa and in 13.8% of F-Decalin, retinal holes in 14,6% of Ala® Octa and in none of F-Decalin, outer retinal inclusions in 20,8% of Ala® Octa and in 3.45% of F-Decalin. CONCLUSION:Ala® Octa has caused significantly more toxic damage than F-Decalin. Special consideration should be given to develop a central European control agency for medical devices and to reevaluate safety procedures currently accepted by the EU and ISO standard for intraocular surgery.
Authors: Rosa M Coco-Martin; Cristina Andrés-Iglesias; Girish K Srivastava; Javier Lagos-Rodriguez; Miguel Ruiz-Tevah; Mario R Díaz-Cárdenas; Ivan Fernandez-Bueno; Juan García-Serna; María T García-Gutierrez; Alfredo García-Layana; J Carlos Pastor Journal: Sci Rep Date: 2021-01-12 Impact factor: 4.379