BLINDNESS RELATED TO PRESUMED RETINAL TOXICITY AFTER USING PERFLUOROCARBON LIQUID DURING VITREORETINAL SURGERY.

PURPOSE: To describe the presumed retinal toxicity after using specific batches of perfluorocarbon liquid ALA OCTA (Alamedics, Dornstadt, Germany) in pars plana vitrectomy. METHODS: This is an observational retrospective consecutive case series analyses of patients operated on pars plana vitrectomy for retinal detachment or intraocular lens subluxation, using the 150141 or 200114 batches of perfluorocarbon liquid ALA OCTA as assistance during the surgery in a single center. Patients were included in this report if they manifested retinal toxicity signs throughout the follow-up, such as retinal and retinal pigment epithelium atrophy, disk paleness, and intensive macular fibrosis. Spectral domain optical coherence tomography (Spectralis; Heidelberg Engineering, Heidelberg, Germany) and Ultra-Wide Field 200° retinal camera (Optos P200Tx; Optos, Scotland, United Kingdom) images, electrophysiological tests, and visual fields were performed to analyze the retinal structure and functionality. RESULTS: Seven of 80 patients showed all the described signs of toxicity, after a mean follow-up of 34.29 days (range: 10-87) since surgery. Four patients needed a second pars plana vitrectomy because of tractional retinal detachment and proliferative vitreoretinopathy, and two of them underwent a third surgery because of redetachment. All patients experienced amaurosis or central scotoma, with a final best-corrected visual acuity ranging from 20/200 to light perception. CONCLUSION: Presumed toxic batches of perfluorocarbon liquid may cause massive retinal toxicity. A rapid suspicion, a correct traceability of surgical products, and informing health authorities are fundamental to prevent further cases of toxicity.

ACUTE RETINAL DAMAGE AFTER USING A TOXIC PERFLUORO-OCTANE FOR VITREO-RETINAL SURGERY.

PURPOSE: To describe a series of retinal acute toxicity cases with severe visual loss after intraocular use of a toxic perfluoro-octane (PFO). The clinical presentation is described, and the likely causes are analyzed. New biological methods for testing safety of intraocular medical devices are proposed. METHODS: Information regarding a series of eyes suffering acute severe events after intraocular use of a toxic PFO was analyzed. Four types of spectroscopy, nuclear magnetic resonance, and chromatography were used to identify the potential PFO contaminants. Cultures of human retinal pigment epithelial cells (ARPE-19) and porcine neuroretina were used to quantify the toxicity of the suspect PFO lots. RESULTS: Of 117 cases of intraocular toxicity, 96 were considered clearly related to the use of PFO. Fifty-three cases had no light perception, and 97 had no measurable visual acuity. Retinal necrosis (n = 38) and vascular occlusion (n = 33) were the most characteristic findings. Two hydroxyl compounds, perfluorooctanoic acid and dodecafluoro-1-heptanol, and benzene derivatives were identified as the suspected toxic agents. While existing toxicity testing failed, we proposed new tests that demonstrated clear toxicity. CONCLUSION: Protocols to determine cytotoxicity of intraocular medical devices should be revised to assure safety. Acute toxic events should be reported to health authorities and scientific media.

Prevalence of Vitreoretinal Interface Abnormalities on Spectral-Domain OCT in Healthy Participants over 45 Years of Age.

PURPOSE: To assess the prevalence of vitreoretinal interface abnormalities in a general population of healthy adults ≥45 years of age. DESIGN: Cross-sectional study carried out at 17 ophthalmology services throughout Spain. PARTICIPANTS: Between September 2015 and March 2016, all consecutive healthy persons aged ≥45 years who were accompanying patients to ophthalmology services were invited to take part in the study. Exclusion criteria were known retinal disease, uveitis, history of ocular trauma or previous intraocular surgery (including cataract surgery and intravitreal injections), severe myopia (>-6 dioptres), and poor ocular media transparency. METHODS: Spectral-domain OCT or swept-source OCT was performed on all participants. Diseases of the vitreomacular interface were classified according to the OCT-based anatomic classification system of the International Vitreomacular Traction Study Group. All pathologic and borderline images as well as doubtful cases were evaluated blindly in a central reading center. MAIN OUTCOME MEASURES: Prevalence of vitreomacular interface abnormalities (vitreomacular traction epiretinal membrane, lamellar hole). RESULTS: The study included 2257 participants with a mean age of 59.5 years (range 45-90), and a total of 4490 eyes (right eyes 2242, left eyes 2248). Vitreoretinal interface abnormalities were detected in 70 eyes, with a prevalence of 1.6%. Vitreomacular adhesion was observed in 1317 eyes (29.3%). Results of spectral-domain OCT or swept-source OCT examination were unrevealing in 3103 eyes. Vitreoretinal interface abnormalities were found in 61 participants, with a prevalence in the study population of 2.7%. Vitreomacular traction was observed in 14 participants (0.6%), epiretinal membrane in 44 (1.9%), and lamellar macular hole in 3 (0.1%). The prevalence of both vitreomacular traction and epiretinal membrane increased significantly with age. The presence of vitreoretinal interface abnormalities was unrelated to concomitant diabetes mellitus or hypertension. CONCLUSIONS: An important percentage of healthy participants from the general population ≥45 years of age showed vitreoretinal interface abnormalities. Screening with OCT is advisable at any first routine consultation or preoperative assessment, particularly in older participants.