Comparative Study of the NIDEK TONOREF III With the Haag-Streit, Perkins Hand-held Applanation Tonometer for Tonometry Function and NIDEK TONOREF III With the NIDEK CEM-530 for Pachymetry Function

The primary objective of this clinical study is to prove that tonometry values for NIDEK TONOREF III are comparable to the predicate device and to prove that the pachymeter function of NIDEK TONOREF III is equivalent to the predicate device. The secondary objective is to demonstrate that the test device is as safe as the predicate devices.

开始日期2024-06-27

申办/合作机构

Nidek Co., Ltd.

NCT04318132 / CompletedN/A

Agreement and Precision Study of the Nidek Mirante OCT Compared to the Optovue RTVue XR Avanti OCT and SLO Image Comparison of the Nidek Mirante and the OPTOS P200DTx

This study is a prospective comparative, randomized, single center study to gather agreement and precision of the Nidek Mirante OCT with SLO and Anterior Segment Imaging capabilities in comparison to the Optovue RTVue XR Avanti OCT and Optos P200DTx in normal subjects, subjects with glaucoma, subjects with retinal disease and subjects with corneal disease.

开始日期2020-01-25

申办/合作机构

Nidek Co., Ltd.

NCT03441477 / CompletedN/A

Comparative Study of the NIDEK TONOREF III and the Haag-Streit Goldmann Manual Tonometer (Predicate) to Demonstrate Conformance to ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and to the Applicable Supplemental Information Sheet and Comparison of Pachymetry Values for NIDEK TONOREF III With the NIDEK CEM-530 (Predicate)

开始日期2017-12-17

申办/合作机构

Nidek Co., Ltd.

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2023-09-28·SENSORS AND MATERIALS

Development of a Humidity Microsensor for Evaluation of Hermeticity for Retinal Prosthesis

作者: Tashiro, Hiroyuki ; Terasawa, Yasuo ; Ohta, Jun ; Kono, Takuro

Retinal prosthesis requires a microhermetic package with long-term reliability for the intraocular implantation of devices.The evaluation of the hermetic package generally involves leak testing, but it is challenging to detect micropackages by leak tests owing to their small volumeTherefore, a sensor that can sense the environment inside the package is necessary.However, conventional sensors are too large to be mounted inside a micropackage.To address this issue, we fabricated a humidity microsensor that is compatible with a microhermetic package and evaluated its performance.The humidity microsensor was fabricated by layering a sensitive film on glass using a simple photolithog. technique.The humidity microsensor exhibited a linear response to changes in relative humidity in a 25 °C environment with a capacitance change of 0.059 pF.By using the humidity microsensor, we successfully detected device failure in the microhermetic package.Moreover, the fabricated humidity microsensor operated stably for >14 days under transient thermal stress at 200 °C during hermetic sealing and under continuous thermal stress during accelerated testing at 87 °C.These results demonstrate that the fabricated humidity microsensor is useful for evaluating the long-term reliability of microhermetic packages.

2023-08-01·Die Naturwissenschaften

Eggs in faeces: defensive mechanisms and effects of faecal coating by a water scavenger beetle, Coelostoma stultum (Coleopterea: Hydrophilidae)

Article

作者: Yokoi, Tomoyuki ; Matsushima, Ryosuke

The egg stage in insect development is vulnerable to fluctuations in environmental conditions and attacks by natural enemies. Protective devices are effective means of avoiding both abiotic and biotic damage to eggs. Although some insects use their faeces as a protective device, few studies have focused on using faeces for egg protection, and studies that examined the mechanism are lacking. Females of a water scavenger beetle, Coelostoma stultum, typically lay eggs and coat them with cocoons and their faeces. The efficacy of a double defensive device, however, remains uncertain. Here, we conducted field observations and laboratory experiments to assess the protective effects of cocoons with faecal coating on eggs against predation and determine the duration and mechanisms of this defence. Our findings reveal that the faeces on the egg cocoon protected eggs from predation by the pill bugs, Armadillidium vulgare, and marsh slugs, Deroceras laeve. Laboratory experiments showed that the defensive effect of faecal coating was maintained for three days and decreased daily. The double protective traits with faecal coating on the egg cocoons protected the eggs from instense predation pressure in C. stultum. The behavioural patterns of the pill bugs and egg predation rates indicate that the faecal coating behaviour in C. stultum protects eggs with chemical compounds and textural camouflage in mud when the antennae of the pill bugs touch faeces. It is important to note that for this defence to be effective, the chemistry and texture of the faeces should be similar to that of the oviposition sites.

2023-01-01·PloS one

Wayfinding artificial intelligence to detect clinically meaningful spots of retinal diseases: Artificial intelligence to help retina specialists in real world practice.

Article

作者: Terasaki, Hiroto ; Sonoda, Shozo ; Sakamoto, Taiji ; Shiba, Yousuke ; Funatsu, Ryoh ; Shiihara, Hideki ; Fujiwara, Kazuki ; Honda, Naoto ; Kumagai, Yoshiki

AIM/BACKGROUND:

To aim of this study is to develop an artificial intelligence (AI) that aids in the thought process by providing retinal clinicians with clinically meaningful or abnormal findings rather than just a final diagnosis, i.e., a "wayfinding AI."

METHODS:

Spectral domain optical coherence tomography B-scan images were classified into 189 normal and 111 diseased eyes. These were automatically segmented using a deep-learning based boundary-layer detection model. During segmentation, the AI model calculates the probability of the boundary surface of the layer for each A-scan. If this probability distribution is not biased toward a single point, layer detection is defined as ambiguous. This ambiguity was calculated using entropy, and a value referred to as the ambiguity index was calculated for each OCT image. The ability of the ambiguity index to classify normal and diseased images and the presence or absence of abnormalities in each layer of the retina were evaluated based on the area under the curve (AUC). A heatmap, i.e., an ambiguity-map, of each layer, that changes the color according to the ambiguity index value, was also created.

RESULTS:

The ambiguity index of the overall retina of the normal and disease-affected images (mean ± SD) were 1.76 ± 0.10 and 2.06 ± 0.22, respectively, with a significant difference (p < 0.05). The AUC used to distinguish normal and disease-affected images using the ambiguity index was 0.93, and was 0.588 for the internal limiting membrane boundary, 0.902 for the nerve fiber layer/ganglion cell layer boundary, 0.920 for the inner plexiform layer/inner nuclear layer boundary, 0.882 for the outer plexiform layer/outer nuclear layer boundary, 0.926 for the ellipsoid zone line, and 0.866 for the retinal pigment epithelium/Bruch's membrane boundary. Three representative cases reveal the usefulness of an ambiguity map.

CONCLUSIONS:

The present AI algorithm can pinpoint abnormal retinal lesions in OCT images, and its localization is known at a glance when using an ambiguity map. This will help diagnose the processes of clinicians as a wayfinding tool.

项与 Nidek Co., Ltd. 相关的新闻（医药）

2024-01-16

·PRNewswire

Orbis International and NIDEK Join Forces to Scale Up Artificial Intelligence Eye Screenings in Vietnam

The ophthalmic equipment manufacturer donates cameras and awards financial support to the global eye care nonprofit's Vietnam program over the next three years. NEW YORK, Jan. 16, 2024 /PRNewswire/ -- Orbis International announces an important in-kind and financial donation from NIDEK to support Orbis's artificial intelligence (AI)-based screening services in Vietnam. The donation of six specialized fundus cameras, which take images of the retina (back of the eye), will support the scale up of Orbis' AI-based diabetic retinopathy screening program in Vietnam. These cameras are expected to support the screening of 72,000 patients with diabetes over the next three years. Continue Reading Dr. Hieu uses Orbis’s Cybersight AI platform to detect diabetic retinopathy and other blinding eye diseases at My Tho district health center in Vietnam. Photo: Orbis International The addition of the NIDEK cameras to Orbis's program will expand its presence to six high-volume screening health facilities in three provinces across Vietnam – including Giao Thuy District Health Center and Nam Dinh General Hospital in Nam Dinh province, Nghe An Endocrinology Hospital and Tay Bac Regional Hospital in Nghe An province and Can Tho General Hospital and Can Tho Heart Hospital in Can Tho city – improving capacity to detect and promptly treat diabetic retinopathy, a potentially blinding disease that every person with diabetes is at risk of developing. Images from NIDEK's superior desktop fundus cameras will be uploaded to and graded by Cybersight AI, Orbis's state-of-the-art technology, determining within seconds if diabetic retinopathy is detected. This allows patients the opportunity to be referred immediately for treatment, without first waiting days or even weeks for screening results that rely on human grading of the images. "According to the Vietnam National Endocrinology Hospital, in the past 20 years, the prevalence of diabetes in the country has increased from 2.7% of the population to 7.3% of the population, and this trend continues to grow," said Ngoc Pham, Country Director, Orbis Vietnam. "There are not enough trained medical professionals to meet the demand for eye screening for people living with diabetes. Cybersight AI and high-quality cameras will help ease the burden on medical facilities already at capacity by detecting diabetic retinopathy." "We are excited and confident that our partnership with Orbis and technological collaboration with their Cybersight AI, will certainly improve the diabetic retinopathy screening situation in Vietnam." says Motoki Ozawa, President and CEO of NIDEK CO., LTD. "Our purpose is to provide the joy of vision and health care through our technology and deliver unwavering commitment to people all over the world. We are committed to deliver joy of vision to people in Vietnam by supporting early detection and immediate referrals". Diabetic retinopathy is an eye disease that effects approximately one in three people living with diabetes. If left untreated, it can lead to vision loss and blindness. Most people living with diabetes reside in low- and middle-income countries, like Vietnam. Vietnam has approximately 7 million people with diabetes, and diabetic retinopathy is one of the leading causes of blindness and vision loss in the country. About Orbis Orbis is an international nonprofit delivering sight-saving programs in over 200 countries and regions worldwide so that individuals, families, and communities can thrive. Currently, around 1 billion people across the globe live with completely avoidable blindness and vision loss. For over four decades, Orbis has been tackling this challenge by building strong and sustainable eye care systems that leave a lasting legacy of vision. Orbis runs dedicated in-country programs in Africa, Asia, the Caribbean, and Latin America; develops and implements innovative training and technology, including an award-winning telemedicine and e-learning platform, Cybersight; and operates the world's first and only Flying Eye Hospital, a fully accredited ophthalmic teaching hospital on board an MD-10 aircraft. For the past ten consecutive years, Orbis has achieved Charity Navigator's coveted four-star rating for demonstrating strong financial health and commitment to accountability and transparency, placing Orbis in the top 3% of U.S. charities. For the past two years, Orbis has earned GuideStar's platinum Seal of Transparency. In 2022, Orbis earned "accredited charity" status from the Better Business Bureau by meeting all 20 of their standards for charity accountability. To learn more, please visit orbis.org. About NIDEK NIDEK CO., LTD., is a global leader in the design, manufacture, and distribution of ophthalmic, optometric, and lens edging equipment. Due to their technological expertise in combing optical and electronic technologies, the company has been at the forefront of ophthalmic innovation, creating industry leading products. MEDIA CONTACT Orbis International Jenna Montgomery Manager, Global Communications and Marketing [email protected] NIDEK CO., LTD. Secretariat & Public Relations [email protected] SOURCE Orbis International

2023-02-15

·Business Wire

Global Ophthalmic Devices Technologies and Markets 2023: Technological Advancements and Increasing Government Initiatives Drive Growth - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Ophthalmic Devices: Technologies and Global Markets" report has been added to ResearchAndMarkets.com's offering. In recent years there have been significant advances in the development of ophthalmic devices and surgical procedures that have helped to improve diagnosis and treatment of a broad range of ophthalmic conditions, including cataracts, glaucoma, refractory and retinal disorders. The growth is being driven by the launch of new biocompatible materials, improvements in clinical optics and the launch of high-end surgical devices. Advancements in cataract and refractory surgery devices have also resulted in the improved safety and efficacy of routine procedures, helping to improve surgical outcomes, reduce perioperative morbidity and increase the number of patients willing to undergo surgery. The global ophthalmology device market is being driven by patient demographics such as the rising incidence of diabetes and obesity and the increasing geriatric population, which is increasing the number of patients with conditions such as age-related macular degeneration, cataracts, diabetic retinopathy and glaucoma, and helping to expand the addressable patient population in need of ophthalmic devices. In addition, market growth is being aided by growing awareness and early detection and monitoring of ocular disease, the rise in adoption of minimally invasive surgeries in Asia-Pacific, greater healthcare insurance coverage in Europe and positive reimbursement of ocular devices and surgical procedures in the United States. The market is dominated by a few players: EssilorLuxottica, Alcon, Bausch & Lomb, Carl Zeiss Meditec, CooperVision, Johnson & Johnson, Nidek, Topcon Corp. and Hoya Vision Care. Innovative new companies such as EyeKon Medical, Glaukos Corp.,Optos and others, are gradually making headway in the market. Within the market, EssilorLuxottica is the dominant player. Growth in this market has been driven by the innovations in eyeglasses and biocompatible materials encompassing silicone hydrogels, hydrogels and newly emerging hybrid materials, all of which are designed to improve contact lens safety and comfort. Report Includes 50 data tables and 13 additional tables A detailed overview and up-to-date analysis of the global markets for ophthalmic devices and related technologies Analyses of the global and regional market trends, with data for 2019-2022, and projections of compound annual growth rates (CAGRs) through 2027 Discussion of the industry growth driving factors and challenges that will shape the market for ophthalmic devices as a basis for projecting demand over the next few years (2022-2027) Estimation of the actual market size and revenue forecast for global ophthalmic devices market in USD millions, and corresponding market share analysis by technology type, application, and region Analysis of the recent advances in contact lenses, cataract surgery, implantation ophthalmic devices, and complex medical surgeries; and their potential impact on diagnosis of prevalent eye conditions and improved healthcare solutions In-depth information (facts and figures) concerning major market dynamics, technology updates, latest developments, industry regulations, and other macroeconomic forces affecting the present and future market outlook Assessment of the recent industry structure, ongoing research activities, analysis of competitive environment, and COVID-19 effects on the ophthalmic devices market ecosystem Patent review and analysis of patent grants on ophthalmic device technologies Identification of the major stakeholders and analysis of the competitive landscape based on recent developments and segmental revenues Market Dynamics Drivers Aging Population with Growing Eye Care Needs Technological Advancements Increasing Government Initiatives Increasing Wealth and Growth from Emerging Economics Increasing Prevalence of Vision Impairment Barriers High Cost and Risk Associated with Eye Surgery Lack of Skilled Professionals Accessibility, Acceptability Opportunities Growing Aging Population and Rising Demand for Vision Care Use of Mobile-Based and Artificial Intelligence Technologies Company Profiles Alcon Bausch + Lomb Inc. Bio-Tissue Inc. Coopervision Dutch Ophthalmic Research Center International Bv Ellex Medical Lasers Essilorluxottica Eyenuk Inc. Glaukos Heidelberg Engineering Gmbh Hoya Corp. Ioptima Ltd. Iridex Corp. Johnson & Johnson Lenstec Inc. Lumenis Nidek Co. Ltd. Oasis Medical Inc. Quantel Medical Sav-Iol Sa Shanghai Haohai Biological Technology Co. Ltd. Sight Sciences Inc. Softcare Solution Inc. Staar Surgical Tearscience Inc. Topcon Vasoptic Medical Inc. Zeiss Group Ziemer Ophthalmic Systems Ag For more information about this report visit https://www.researchandmarkets.com/r/g6jub5 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

2023-01-31

·PRNewswire

Worldwide Intraocular Lenses Industry to 2027 - Increasing Demand for Ophthalmic Surgery for Vision Correction Presents Opportunities

DUBLIN, Jan. 31, 2023 /PRNewswire/ -- The "Intraocular Lenses: Global Market Outlook" report has been added to ResearchAndMarkets.com's offering. In this report, the market has been segmented based on organization size, component, provider, type, industry and geography. The report provides an overview of the intraocular lens (IOL) global market and analyses market trends. Using 2021 as the base year, the report provides estimated market data for the forecast period from 2022 to 2027. Revenue forecasts for this period are segmented based on product type, material, indication and geography. Market values have been estimated based on the total revenue of IOL solution providers. The report covers the market for IOL with regard to the product type across different regions. It also highlights major trends and challenges that affect the market and the vendor landscape. The report estimates the global market for IOL in 2021 and provides projections for the expected market size through 2027. The regional market analysis of IOL devices is also covered in this report. The market has been segmented into various major geographies, including North America, Europe, Asia-Pacific and Rest of World regions. Detailed analysis of major countries (e.g., the U.S., Germany, the U.K., Italy, France, Japan, China, India, Brazil, Mexico, GCC countries) will be covered within the regional segment. For market estimates, data are provided for 2020 because of the base year 2021, with estimates for 2022 and forecast value for 2027. The scope of the study includes IOL devices and accessories that have been medically accepted and approved in the market, as well as sleep devices, which have been excluded from the study. Report Includes 21 data tables and 2 additional tables A brief general outlook of the global market for intraocular lens (IOLs) within the medical devices industry Analyses of the global market trends, with market revenue data for 2021, estimates for 2022, and projections of compound annual growth rates (CAGRs) through 2027 Highlights of key market potential for intraocular lens, technological trends, opportunities, and gaps estimating the current and future demand for IOLs market demand over the analysis period Estimation of the actual market size and revenue forecast for global intraocular lens market in USD million values, and corresponding market share analysis based on product type, age group, disease indication, and region In-depth analysis for each of the market segments based on the product type such as monofocal lens, multifocal lens, toric lens, and extended depth of focus (EDOF) lens across key geographies Information pertaining to strategic profiling of key companies (manufacturers and distributors) present across the globe and their competitive landscape, product launch strategies, and financial outlook Company profiles of major players within the industry, including Alcon, Bausch + Lomb, Hoya Corp., and Johnson & Johnson Key Topics Covered: Chapter 1 Market Outlook Chapter 2 Executive Summary Chapter 3 Market Overview 3.1 Market Drivers 3.1.1 Rise in Geriatric Population and Vision Disorders (High Impact) 3.1.2 Rise in Volume of Cataract Surgeries (High Impact) 3.1.3 Soaring Screen Time and Increasing Incidence of Computer Vision Syndrome (High Impact) 3.2 Market Restraints 3.2.1 Dearth of Eye Care Health Personnel and Low Affordability in Emerging Countries (Moderate Impact) 3.2.2 Increasing Number of Surgical Procedures for Permanent Vision Correction (High Impact) 3.3 Market Opportunities 3.3.1 Increasing Demand for Ophthalmic Surgery for Vision Correction 3.4 Macroeconomic Factors Affecting the Global Market for Intraocular Lenses 3.4.1 Innovation of Personalized and Three-Dimensionally Printed Lenses 3.4.2 Advent of Smart Eyeglasses and Smart Contact Lenses 3.4.3 Contribution to Improving Ophthalmic Medical Access in Developing Countries Chapter 4 Impact of the Covid-19 Pandemic on the Vision Care Market 4.1 Introduction 4.2 Impacts 4.2.1 Momentary Halt in Product Manufacturing 4.2.2 Delays in Elective Surgical Procedures 4.2.3 Cancellation and Postponement of Eye Exams 4.2.4 Trade Restrictions and Supply Disruptions 4.3 Outline of Covid-19'S Impact on the Vision Care and Iol Market 4.4 Possible Post-Covid-19 Vision Care Market Scenario Chapter 5 Market Breakdown by Product Type, Indication, and Material 5.1 Market for Intraocular Lenses by Product Type 5.1.1 Monofocal Lenses 5.1.2 Multifocal Lenses 5.1.3 Toric Lenses 5.1.4 Extended Depth of Focus Lenses 5.1.5 Other Lenses 5.1.6 Market Size and Forecast 5.2 Market for Intraocular Lenses by Indication 5.2.1 Market Size and Forecast 5.3 Market for Intraocular Lenses by Material 5.3.1 Market Size and Forecast Chapter 6 Market Breakdown by Region 6.1 Global Market for Intraocular Lenses by Region 6.2 North America 6.3 Europe 6.4 Asia-Pacific 6.5 Rest of the World Chapter 7 Competitive Landscape 7.1 Market Shares and Ranking of the Top Companies 7.2 Strategic Analysis 7.2.1 Product Launches and Developments Chapter 8 Company Profiles 8.1 Intraocular Lens Service, Infrastructure and Platform Providers Alcon Bausch + Lomb Carl Zeiss Hoya Corp. Johnson & Johnson Nidek Co. Ltd. Rayner Rxsight Chapter 9 Project Scope and Methodology For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

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