DYNAMIC CHANGES OF THE POSTERIOR POLE OF THE EYE AFTER CATARACT PHACOEMULSIFICATION WITH INTRAOCULAR LENS IMPLANTATION

Objective. To study the effect of uncomplicated phacoemulsification through the corneal incision with implantation of the intraocular lens (IOL) for changes in the macular region of the retina. Methods: The study included 35 eyes of 35 patients who underwent uncomplicated phacoemulsification with IOL implantation. The average age of the patients was 67±2,3 years, among them were 19 women and 16 men. Exclusion criteria: retinal pathology (postthrombotic and diabetic retinopathy, wet form of age-related macular degeneration and other diseases of the retina), previous eye injuries, uveitis, intra-operative complications. Retinal thickness in the fovea, the macula, and macular volume were measured by optical coherence tomography on the first day, after 2 weeks, 1 and 3 months after surgery. Results. In the period between the first day and two weeks after surgery there were the statistically significant incensement in retinal thickness in the macula from 306,64±21,15 mkm to 321,46±27,83 mkm (p <0.05), in the fovea from 211,45±20,24 mkm to 218,69±17,84 mkm (p<0.05), macular volume from 8,08±0,35 cubic mm to 8,46±0,54 cubic mm were registered. By the end of the first month after surgery maximum retinal thickness was 327,23±27,16 mkm, thickness in the fovea 220,31±18,63 mkm, macular volume 8,61±0,55 cubic mm. After 3 months, the maximum thickness of the retina reached 325,11±26,13 mkm, in the fovea 220,31±18,63 mkm, macular volume 8,55±0,49 cubic mm. Conclusion. There was an incensement of macular volume and retinal thickness in the period between the first day and two weeks after uncomplicated cataract phacoemulsification with intraocular lens implantation. The growth of these indicators continued within the first month after surgery, three months after phacoemulsification there was a downward trend. This can be important in determining the duration of drug therapy in the postoperative period

Ion-beam sputtering of NiO hole transporting layers for p-i-n halide perovskite solar cells

Ion-beam sputtering offers significant benefits in terms of deposition uniformity and pinhole-free thin-films without limiting the scalability of the process. In this work, the reactive ion-beam sputtering of nickel oxide has been developed for the hole transporting layer of a p-i-n perovskite solar cells (PCSs). The process is carried out by oxidation of the scattered Ni particles with additional post-treatment annealing regimes. Using deposition rate of 1.2 nm/min allowed growth of very uniform NiO coating with the roughness below 0.5 nm on polished Si wafer (15x15 cm2). We performed a complex investigation of structural, optical, surface and electrical properties of the NiO thin-films. The post-treatment annealing (150-300C) was considered as an essential process for improvement of the optical transparency, decrease of defects concentration and gain of the charge carrier mobility. As result, the annealed ion-beam sputtered NiO films delivered a power conversion efficiency (PCE) up to 20.14%, while device without post-treatment reached the value of 11.84%. The improvement of the output performance originated from an increase of the short-circuit current density (Jsc), open circuit voltage (Voc), shunt and contact properties in the devices. We also demonstrate that the ion-beam sputtering of NiO can be successfully implemented for the fabrication of large area modules (54.5 cm2) and PSCs on a flexible plastic substrate (125 microns)

Современные подходы к введению показателя «Аномальная токсичность»

For over 60 years, the Abnormal Toxicity Test (ATT) has been used as an important tool in safety control of some parenteral and veterinary products made from biological materials. In 2017, some of the members of the Pharmacopoeial Committee of the Eurasian Economic Union (EAEU) proposed not to include the ATT in the draft monographs of the EAEU Pharmacopoeia based on the decision of the European Pharmacopoeia Commission to suppress the test. However, this may not be achieved in Russia at this point, because some production sites that manufacture medicinal products for human and veterinary use have not fully implemented GMP principles yet. The main aim of the ATT is to detect any toxicity above the pre-determined acceptable level. The unacceptable toxicity levels can manifest themselves in higher mortality rates or unexpected intoxication effects in laboratory animals. This test makes it possible to detect abnormal (high) toxicity of a medicinal product which may be associated with degradation products or undesirable impurities resulting from changes of the production technology, which are not mentioned in specification documents related to production, transportation, and storage. In 2016—2017 12 batches of veterinary products, including vaccines and sera, were found to be noncompliant, and the Federal Service for Surveillance in Healthcare rejected 16 batches of medicinal products in 2016—2019. The aim of the study was to analyse current approaches to the ATT in the Russian and foreign pharmacopeias, and to develop a programme for phasing out the ATT use depending on the nature and pharmacological properties of medicinal products. Comparative analysis of the monographs of the world leading pharmacopeias showed that the State Pharmacopoeia of the Russian Federation has the most stringent test conditions. As an alternative to suppressing the ATT the authors suggest a phased approach to reduce the use of this test. They determined groups of medicinal products whose pharmacological properties allow for the suppression of the test. The proposed approach to phasing out the use of ATT will make it possible to use the test effectively and reduce the number of performed tests, but will still ensure drug safety. The suppression of the ATT can not be achieved without a comprehensive detailed research by quality control specialists and further discussion by all interested parties.В течение более 60 лет тест на аномальную токсичность используется как один из важных показателей при контроле качества безопасности парентеральных медицинских и ветеринарных препаратов, получаемых из субстанций биологического происхождения. В 2017 г. на заседании Фармакопейного комитета Евразийского экономического союза (ЕАЭС) было предложено не включать тест на аномальную токсичность в проект Фармакопеи ЕАЭС, основанием для данной дискуссии послужил отказ Европейской фармакопеи от данного испытания. Однако на территории нашей страны в настоящее время подобный шаг не может быть реализован, так как не все производственные площадки для производства медицинских и ветеринарных препаратов полностью отвечают международным требованиям GMP Основной целью проведения теста на аномальную токсичность является выявление токсичности препарата, превышающей установленный ранее допустимый уровень, контролируемый по повышению летальности или по неожидаемым (нерегламентированным) явлениям интоксикации животных. Данное испытание позволяет определить аномальную (повышенную) токсичность лекарственного препарата, которая может возникнуть за счет появления продуктов разложения или нежелательных примесей при изменении процесса производства, не предусмотренных регламентом производства, транспортирования или хранения. Так, в течение 2016—2017 гг. количество выявленных несоответствий ветеринарных препаратов, в том числе вакцин и сывороток, составило 12 серий, а Росздравнадзором за период 2016—2019 гг. забраковано 16 серий лекарственных препаратов. Цель работы — анализ современных подходов к тесту «Аномальная токсичность» в отечественной и зарубежных фармакопеях, разработка программы поэтапного сокращения применения теста в зависимости от природы и фармакологических свойств лекарственных средств. В результате сравнительного анализа монографий ведущих фармакопей мира установлено, что действующие требования Государственной фармакопеи Российской Федерации характеризуются наиболее строгими условиями проведения теста. В качестве альтернативы отказу от испытания на аномальную токсичность авторами предложен поэтапный подход, позволяющий сократить использование теста. Определены группы препаратов, фармакологические свойства которых позволяют исключить показатель. Предложенный поэтапный подход к сокращению использования показателя «Аномальная токсичность» позволит сделать тест более рациональным и сократить количество испытаний, но по-прежнему будет способствовать обеспечению безопасности применения лекарственных препаратов. Исключение испытания на аномальную токсичность не может быть реализовано без всесторонней детальной проработки специалистами в области контроля качества и дальнейшего обсуждения этого вопроса всеми заинтересованными сторонами

Leukemic optic nerve infiltration as the first symptom of neuroleukemia

Extramedullary leukemic foci in acute leukemia attract special attention. They reflect the diversity of clinical manifestations of the disease, affect the severity of the patient’s condition and may influence the choice of treatment strategy. Purpose: to present a rare clinical case of leukemic optical neuropathy in a patient with acute lymphoblast leukemia. Results. Decreased visual acuity of both eyes related to the involvement of the optic nerve was one of the main complaints of the female patient during the onset of the diseases. A loose greyish tumor with blurred contours was identified on the optic nerve disc, with a large number of hemorrhages in various layers of the peripapillary retina. During ophthalmoscopy, the central vessels in the optic disc funnel could not be distinctly differentiated. Brain and orbit MRI showed intraocular masses in the area of the projection of the optic nerve disc and a lesion in the left frontal lobe. There were no signs of high intracranial pressure. After the first chemotherapy course for acute leukemia, visual acuity of both eyes increased, along with a substantial regression of tumor infiltration of the optic disc, which made it possible to visualize the border of the optic disc and the central retinal vessels. Follow-up images showed a full regression of the mass in both eyeballs. The left frontal lesion, whose origin was unclear, remained unchanged. Conclusion. An isolated lesion of the optic nerve could be a potential first sign of neuroleukemia, so it should be on the list for differential diagnosis of optic nerve disorders. First of all, leukemic optic neuropathy should be differentiated from optic nerve edema. Early diagnosis of neuroleukemia and adequate anti-tumor treatment allow for significant improvement of visual acuity and hence, for better quality of life of patients with leukemia // Russian Ophthalmological Journal, 2016; 4: 64-8. doi: 10.21516/2072-0076-2016-9-4-64-68.

EFFICACY AND SAFETY OF A NEW COMBINED MEDICATION WITH RECOMBINANT INTERFERON AND BETAMETHASONE IN THE TREATMENT OF HAY FEVER DURING PERIODS OF EXACERBATION

Objective: to assess the efficacy, safety and tolerability of the new combined medication Allergoferon® beta in patients with moderate-to-severe hay fever (seasonal allergic rhinitis and conjunctivitis) during periods of exacerbation. patients and methods: the object of our study was medication Allergoferon® beta (recombinant human interferon alpha-2b, not less than 5000 IU/ml + betamethasone sodium phosphate, 1.0 mg/ml) in the form of eye and nasal drops. Total of 120 patients aged 18-65 years with hay fever for at least two years were enrolled in the clinical trial, including 76 women and 44 men. All patients had a clinical picture of moderate-to-severe hay fever during periods of exacerbation. Patients were divided into two equal groups. The main group received Allergoferon® beta, the control group was treated with Oftan® Dexamethasone and Nasobek medications. This trial used a randomized, open-label, multicenter, parallel, comparative, controlled study design. results: we found that new combined medication Allergoferon® beta had a significant therapeutic effect in relieving main clinical manifestations of acute hay fever and showed a higher efficacy, than the comparison remedies. By comparing similar symptoms in both groups, we observed that in patients treated with Allergoferon® beta clinical symptoms of acute hay fever were relieved earlier (on the 5th day of treatment), than in the control group (on the 10th day of treatment) and the disease itself proceeded milder. Therapeutic efficacy of Allergoferon® beta was 85,96% (in the control group — 74,73%, p<0.05). During clinical trial we have not observed any adverse effects; general or local toxic and allergic reactions were also not discovered. The medication tolerability was rated as “good” for patients. Conclusion: according to the clinical study results, the medication Allergoferon® beta (eye and nasal drops) is recommended for the state registration and can be used by medical professionals in the treatment of moderate-to-severe hay fever (seasonal allergic rhinitis and conjunctivitis), including periods of exacerbation

Perfuziya miokarda u zhenshchin, stradayushchikh sakharnym diabetom tipa 2 v menopauze

Цель: изучение состояния сердечно-сосудистой системы у женщин с СД типа 2. Обследовали 26 больных сахарным диабетом. Первую группу составили 8 женщин с СД типа I. Средний возраст 53 ?2.5 года. Больные не курили, наследственность по сахарному диабету и сердечно-сосудистым заболеваниям не отягощена. Вторую группу составили 18 женщин с диабетом типа 2. Средний возраст составил 51.7+0.99 лет, близкие родственники у 13 были больны СД, а у 16 женщин наследственность отягощена сердечно-сосудистыми заболеваниями. Продолжительность болезни составила 12.0+2.8 года, что в среднем на 41.5 %. Результаты: Полученные нами данные впервые демонстрируют не только важность проведения этого исследования, но высокий процент встречаемости ИБС у обследованных нами больных. Невнимание к данному контингенту больных, отсутствие разработанных алгоритмов диагностики привело к тому, что ИБС у них не была вовремя диагностирована и больные не получали надлежащего лечения. Женщин в менопаузе при выявлении СД следует рассматривать как группу высокого риска развития ИБС, нуждающихся в обязательном комплексном обследовании для уточнения степени тяжести поражения миокарда. Женщины, страдающие СД типа 2 в менопаузе, нуждаются в активном подходе к диагностике атеросклероза. Выявление и активная коррекция факторов риска ? гипергликемии, артериальной гипертензии, дислипидемии являются необходимыми и обязательными условиями лечения женщин с СД типа 2 в менопаузе. Алгоритм обследования больных не должен зависеть от длительности СД

Various Types of Neuroleukemia with Optic Nerve Involvement

Neuroleukemia is a severe complication of hemoblastosises characterized by infiltration of blast cells of the meninges, the substance of the brain, cranial and peripheral nerves.The purpose. To analyze the clinical manifestations of leukemia with optic nerve damage in leukemia and malignant lymphomas.Patients and Methods. From January 2016 to January 2020, one center-based non-randomized prospective study was conducted on patients with leukemia and non-Hodgkin’s lymphomas who were treated in the hematology department of MONIKI and made complaints about reduced vision. 26 patients were examined, 4 of them were diagnosed neuroleukosis with leukemic infiltration of the optic nerves: three women aged 41, 44, 46 years and a man aged 50 years.Results. All patients had one common ophthalmological symptom — decreased visual acuity. Complaints of reduced vision in one patient appeared at the onset of the disease, in other patients-during a relapse. The picture of the eye’s fundus in all patients was identical: the optic disk had blurred borders, and elevated above the retina. In the first days, the vascular funnel was viewed, then closed by infiltration. A dense white infiltrate of the peripapillary retina spread over the entire macular area. The retinal veins were sharply dilated of uneven caliber. Along the course of the vessels, there were a large number of different sizes and shapes of hemorrhages. Various types of neuroleukemia with lesion of the optic nerve were described: a combination of focal lesions of the brain and the optic nerve, isolated damage to the optic nerve with blast cytosis in the cerebrospinal fluid (CSF), isolated damage to the intraocular part of the optic nerve without changing the cerebrospinal fluid. In three patients the diagnosis of neuroleukemia exhibited on the basis of changes according to magnetic resonance imaging (MRI) and/or the number of blast cells in punctate liquorologic research. In the fourth patient, in the absence of changes in the liquor and MRI, the diagnosis of leukemic infiltration of the optic nerve was confirmed by data from a cytological examination of a punctate from the peripapillary retina. After the beginning of antitumor treatment, the significant improvement visual acuity and decrease in leukemic infiltrate of the optic disc and retina of the affected eye was noted in all patients.Discussion. Damage of the optic nerve can develop both at the onset of the disease, and relapses of leukemia or aggressive non-Hodgkin’s lymphomas. Leukemic infiltration evolves in all parts of the optic nerve, but more often affects its intraocular portion. The damage to the intraocular part is characterized by the presence of a dense infiltrate both in the area of the papilla and the peripapillary retina.Conclusion. Leukemic infiltration of the optic nerve is manifested by a significant decrease in visual acuity. Careful attention to complaints of reduced vision in patients with leukemia can help to recognize the development of the disease’s debut or its progression. Timely antitumor treatment leads to an improvement in visual acuity and, consequently, an improvement in the quality of life of patients

DETECTION OF OPTICAL DENSITY OF THE MACULAR PIGMENT IN SECONDARY GESTATION

The article presents a new method to diagnose the pathology of macular pigment in repeatedly pregnant women with myopia differently dependent on the age as well as on both refraction and peripheral alterations in cases without clear symptoms when traditional ophthalmic examination doesn’t reveal any existing pathology