ObjectiveTo review the registration and technical data for sodium hyaluronate facial derma fillers. MethodsRecent literature concerning registration for sodium hyaluronate facial derma fillers was reviewed and analyzed. ResultsThe aspects on registration for sodium hyaluronate facial derma fillers include nominating the product, dividing registration unit, filling in a registration application form, preparing the technical data, developing the standard, and developing a registration specification. ConclusionThe main difficulty in registration is how to prepare the research data of that product, so the manufacturers need to enhance their basic research ability and work out a scientific technique routing which could ensure the safety and effectiveness of the product, also help to set up the supportive documents to medical device registration.
ObjectiveTo observe the clinical characteristics of ophthalmic and cerebral artery occlusion after facial cosmetic injection.MethodsA retrospective case study. Twenty patients (20 eyes) with ophthalmic and cerebral artery occlusion in Department of Ophtalmology, The Fourth Hospital of Xi’an from February 2014 to December 2016 were enrolled in this study. There were 2 males (2 eyes) and 18 females (18 eyes). They aged from 21 to 41 years, with the mean age of 29.8±1.4 years. The disease courses was ranged from 3.5 hours to 21 days, with the mean of 40 hours. Facial cosmetic injections of all patients were performed at out-of-hospital beauty institutions. The visual impairment was associated with eyelid pain 1 to 10 minutes after injection.There were 12 right eyes and 8 left eyes.The injection materials, 18 patients were hyaluronic acid and 2 patients were autologous fat, respectively. At the injection site, 13 patients were sacral, 4 patients were nasal, and 3 patients were frontal. The concentration and dose of the injected filler were not known. All patients underwent vision, slit lamp microscope, fundus color photography, visual field, FFA, OCT, and brain CT, magnetic resonance angiography (MRA) examination.ResultsThe visual acuity was ranged from no light perception to 1.0. Among the 20 eyes, 3 eyes (15%) were obstructed by simple ophthalmic artery; 5 eyes (25%) were obstructed by ophthalmic artery combined with cerebral artery; 7 eyes (35%) were obstructed by simple retinal artery occlusion (RAO) alone, which including central RAO (CRAO, 4 eyes), hemi-lateral artery obstruction (1 eye) and branch RAO (2 eyes); 1 eye (5%) was CRAO with ciliary artery branch obstruction; 1 eye (5%) was branch artery occlusion with ischemic optic neuropathy; 2 eyes (10%) were CRAO with nasal dorsal artery occlusion; 1 eye (5%) was CRAO, posterior ciliary artery obstruction and right middle cerebral artery occlusion. Among 20 patients, 4 patients (20%) had eye movement disorder and eyelid skin bun; 2 patients (10%) had facial pain and nasal skin ischemic necrosis. MRA revealed 6 patients (30%) of new intracranial ischemic lesions. Among them, 5 patients of hyaluronic acid injection showed asymptomatic small blood vessel embolization; 1 patient of autologous fat injection showed ophthalmary artery occlusion, cerebral artery occlusion, ipsilateral eye blindness, eye movement disorder and contralateral limb hemiplegia.ConclusionFacial cosmetic injection can cause severe iatrogenic complications such as RAO, ciliary artery occlusion, ischemic optic neuropathy, ophthalmic artery occlusion, and cerebral artery occlusion.
ObjectiveTo compare the clinical effects of urokinase thrombolytic therapy for optic artery occlusion (OAO) and retinal artery occlusion (RAO) caused by facial microinjection with hyaluronic acid and spontaneous RAO.MethodsFrom January 2014 to February 2018, 22 eyes of 22 patients with OAO and RAO caused by facial microinjection of hyaluronic acid who received treatment in Xi'an Fourth Hospital were enrolled in this retrospective study (hyaluronic acid group). Twenty-two eyes of 22 patients with spontaneous RAO were selected as the control group. The BCVA examination was performed using the international standard visual acuity chart, which was converted into logMAR visual acuity. FFA was used to measure arm-retinal circulation time (A-Rct) and filling time of retinal artery and its branches (FT). Meanwhile, MRI examination was performed. There were significant differences in age and FT between the two groups (t=14.840, 3.263; P=0.000, 0.003). The differecens of logMAR visual acuity, onset time and A-Rct were not statistically significant between the two groups (t=0.461, 0.107, 1.101; P=0.647, 0.915, 0.277). All patients underwent urokinase thrombolysis after exclusion of thrombolytic therapy. Among the patients in the hyaluronic acid group and control group, there were 6 patients of retrograde ophthalmic thrombolysis via the superior pulchlear artery, 6 patients of retrograde ophthalmic thrombolysis via the internal carotid artery, and 10 patients of intravenous thrombolysis. FFA was reviewed 24 h after treatment, and A-Rct and FT were recorded. Visual acuity was reviewed 30 days after treatment. The occurrence of adverse reactions during and after treatment were observed. The changes of logMAR visual acuity, A-Rct and FT before and after treatment were compared between the two groups using t-test.ResultsAt 24 h after treatment, the A-Rct and FT of the hyaluronic acid group were 21.05±3.42 s and 5.05±2.52 s, which were significantly shorter than before treatment (t=4.569, 2.730; P=0.000, 0.000); the A-Rct and FT in the control group were 19.55±4.14 s and 2.55±0.91 s, which were significantly shorter than before treatment (t=4.114, 7.601; P=0.000, 0.000). There was no significant difference in A-Rct between the two groups at 24 h after treatment (t=1.311, P=0.197). The FT difference was statistically significant between the two groups at 24 h after treatment (t=4.382, P=0.000). There was no significant difference in the shortening time of A-Rct and FT between the two groups (t=0.330, 0.510; P=0.743, 0.613). At 30 days after treatment, the logMAR visual acuity in the hyaluronic acid group and the control group were 0.62±0.32 and 0.43±0.17, which were significantly higher than those before treatment (t=2.289, 5.169; P=0.029, 0.000). The difference of logMAR visual acuity between the two groups after treatment was statistically significant (t=2.872, P=0.008). The difference in logMAR visual acuity before and after treatment between the two groups was statistically significant (t=2.239, P=0.025). No ocular or systemic adverse reactions occurred during or after treatment in all patients. ConclusionsUrokinase thrombolytic therapy for OAO and RAO caused by facial microinjection with hyaluronic acid and spontaneous RAO is safe and effective, with shortening A-Rct, FT and improving visual acuity. However, the improvement of visual acuity after treatment of OAO and RAO caused by facial microinjection with hyaluronic acid is worse than that of spontaneous RAO.