New logos for all subsidiaries, website relaunch, …
mit der FDA-Zulassung (Juni 2020) wurde E-Swin USA gegründet und startete die US-Geschäftsentwicklung
Approbation de la FDA et début du développement des affaires aux États-Unis
with FDA clearance (June 2020) E-Swin USA was incorporated and started US business development
Generally speaking, dry eye conditions are a result of a lacrymal film disorder, due to either insufficient tear production or excessive evaporation of tears:
There are therefore two distinct and non-exclusive pathophysiological forms of dry eye syndrome:
1. The aqua-deficient form (insufficient secretion of tears)
Eye dryness through aqueous deficiency occurs when the principal lacrimal glands are altered and unable to moisten the eye.
2. The evaporative form (excessive evaporation of tears)
The majority of cases are of the evaporative form, mainly caused by the absence or insufficiency of the external lipid layer of lachrymal film secreted by the meibomian glands.
Evaporative dry eye occurs when meibomian glands are defective, when the ocular surface is irregular, when the eyelid structure is abnormal or when contact lenses are worn, for example. Meibomian blepharitis belongs to the evaporative form of dry eye and is related to blockage of the meibomian glands (or tarsal glands). These glands, located in the lower and upper eyelids, are responsible for the production of the lipid layer of the tear film. When these glands dysfunction, the lipid layer becomes insufficient in preventing evaporation of the tear film and providing lubrication of the surface.
The “evaporative” form accounts for 65% to 86% of patients affected by dry eye syndrome. The E-Eye is intended for patients suffering from the evaporative form of meibomian blepharitis.
To demonstrate and evaluate the safety and effectiveness of a pulsed light device in the treatment of meibomian gland dysfunction and to evaluate the safety and effectiveness of pulsed light.
These studies are based on different data: analysis of medical reports, E-Eye tests. Several studies have been carried out, in particular in Australia, New Zealand, China.
Treatment with a polychromatic pulsed light device for a dysfunction described as “dry eye” in the form of a corneal condition associated with a deficiency in the lipid layer, Dr Christian Malbrel, Ophthalmologist.
Prospective trial of intense pulsed light for the treatment of meibomian gland dysfunction. Jennifer P. Craig, Yen-Heng Chen, et Philip R. K. Turnbull, Ocular Surface Laboratory, Department of Ophthalmology, New Zealand National Eye Centre, University of Auckland, Auckland, New Zealand.
Purpose
To evaluate the effect of intense pulsed light (IPL) applied to the periocular area in the treatment of meibomian gland dysfunction (MGD) through a prospective, double-blind, placebo-controlled study.
Methodology
Twenty-eight participants underwent IPL treatment (E-Eye, E-Swin, France), with homogeneously sequenced light pulses delivered to the periocular area of one eye and placebo treatment to the partner control eye at 1, 15, and 45 days following baseline (BL) evaluation. Lipid layer grade (LLG), non-invasive tear break-up time (NIBUT), tear evaporation rate (TER), tear meniscus height (TMH) and subjective symptom score using visual analogue scales (VAS) were compared with BL and control values at each visit.
Results
Lipid layer grade improved significantly from BL to Day (D) 45 in the treated eye (P< 0.001) but not the control eye (P = 0.714), with 82% of treated eyes improving by at least one LLG. Non-invasive tear break-up time also improved significantly from BL to D45 in the treated eye (P < 0.001) but not in the control eye (P = 0.056); it was significantly longer in the treated eye at D45 (14.1 ± 9.8 seconds versus 8.6 ± 8.2 seconds, P < 0.001). The tear evaporation rate was not different in the treated eye compared with the control eye at any visit. Tear meniscus height did not change from BL in either eye (P > 0.05). Visual analogue scale symptom scores improved from BL in the treated eye (P < 0.015), but not the control eye (P = 0.245), with 86% of participants noting reduced symptoms in the treated eye by D45.
Conclusion
Intense pulsed light with multiple sculpted pulses shows therapeutic potential for MGD, improving tear film quality and reducing symptoms of dry eye. (https://www.anzctr. org.au number, ACTRN12614000162617.)
This study was conducted with an E-Eye medical device, identical in all aspects (settings, physical characteristics) to E-Eye devices that are currently manufactured and marketed.
The person in charge of this study was Jennifer P. Craig, a qualified academic optometrist. Her main research interests include dry eye and tear film dysfunction, the cornea, contact lenses and refractive surgery. She currently heads the Ocular Surface Laboratory at the University of Auckland and regularly delivers continuing education and research lectures internationally, as well as publishing in both the scientific and clinical press. She conducted this study with Drs Turnbull and Chen. The clinical trial has been registered at ANZCTR (Australian New Zealand Clinical Trials Registry) under the request number 365741 and is available through this link: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365741
Evaluation of the safety and effectiveness of the controlled discharge xenon flash lamp device in the treatment of dry eye caused by meibomian gland dysfunction, Dr Huibin Lv, Peking University Third Hospital Eye Center.
Purpose
Chronic inflammatory ocular surface dry eye, caused by meibomian gland dysfunction, is very common in clinic. The purpose of this study is to evaluate a new method – Controlled Discharge Xenon Flash Lamp Device – in the treatment of dry eye syndrome caused by meibomian gland dysfunction, its effectiveness and safety.
Equipment
An E-Eye machine was provided by E-Swin, France (www.e-swin.com).
Patients
Patients were enrolled into the study from July 2014 to October 2014, at the Third Hospital of Peking University. The criteria for enrollment and exclusion are shown in Table 1. For diagnosis, the dry eye syndrome should have lasted for at least 12 months, and the tear film break-up time (TBUT) should be less than 10s, while the meibomian gland orifice obstruction should be greater than or equal to grade 1. For the treatment group, all patients had 4 visits: first visit, then 2 weeks, 1 month and 2 months after the first visit. The Controlled Discharge Xenon Flash Lamp Device was applied to the patient at each visit (energy 13.0J/cm2).
General criteria for enrolment in and exclusion from the study:
Enrolment:
Exclusion:
Clinical evaluation
Clinical evaluation included: (1) assessment of dry eye syndrome, (2) eyelid (palpebral blunt, notch, vascular abnormalities, eyelash abnormalities, hyperkeratosis, front blepharitis), (3) meibomian gland (quantity at central 1cm, degree of obstruction, scar, deletion of orifice, nature of the secretion), (4) tear film (BUT, debris, tear foam, height of the upper and lower tear river), (5) cornea and conjunctiva (conjunctival hyperemia, conjunctival flabby, corneal staining).
Statistics
For evaluation of the symptoms, meibomian gland (central 1cm quantity, degree of obstruction, deletion, glandular secretion, tear film (BUT), debris, tear foam, height of upper and lower tear river), cornea and conjunctiva (conjunctival congestion, corneal staining, conjunctival relaxation), scores were analyzed using the paired test. For evaluation of eyelid (eyelid blunt, notch, vascular abnormalities, eyelash abnormalities, hyperkeratosis, front blepharitis) and meibomian gland (scar), the chi square test was used.
Results
Demographic characteristics: The study evaluated 40 dry eye patients with 80 eyes, including 22 female patients (44 eyes) and 18 male patients (36 eyes). The mean age of patients was 51.3 + 20.1 years old (range 21-78 years old).
Conclusion
Using Controlled Discharge Xenon Flash Lamp Device treatment (energy level: 13.0J/cm2), the dry eye symptoms were significantly relieved in patients suffering with meibomian gland dysfunction caused dry eye, and the morphology of the palpebral margin, meibomian gland opening obstruction and meibomian gland quantity were also improved. All the differences between prior and post treatment were statistically significant. In addition, the Controlled Discharge Xenon Flash Lamp Device therapy was shown to improve the tear film quality and prolong the tear break-up time. Following 4 consecutive treatments, the improvement to the dry eye symptoms and the sign of the ocular tissues could be easily maintained. Overall, this study demonstrated that Controlled Discharge Xenon Flash Lamp Device treatment is safe and effective in the treatment of dry eye caused by meibomian gland dysfunction.
The effectiveness of Controlled Discharge Xenon Flash Lamp Device treatment was statistically significant for all the symptoms except blurred vision, while the improvement trends were similar to other signs. In this analysis, 13 symptoms were selected; each of them was scaled from 0 to 10 with 0 meaning no symptom and 10 meaning very serious. During each visit, the patient was asked to self-evaluate the 13 symptoms, and all the evaluations were documented.
You can find all our latest studies on www.esw-vision.com/press-releases
2019 also marks the launch of the tearstim, a second device dedicated to the optical eye care market , the new marketing concept for opticians.
Accompanying E-Swin, Petra Bruckmüller took over the position from the founder, to manage the company with a focus on international development and implementation of new and unique product concepts.
After 2 years of international development of the vision department, ESW Vision was founded as a business unit dedicated to the development of marketing concepts and to distribute the product line for the eye care market.
This new device has been specially certified for the treatment of MGD (Meibomian Gland Dysfunction).
Pre-launch in Australia / New Zealand in the first 18 months.
A team consisting of engineers and software developers is formed. This department is dedicated to “in-house” innovations.
Foundation of E-Swin by Dr. Yves Vincent BROTTIER
D’une manière générale, le syndrome de l’œil sec est le résultat d’une déficience du film lacrymal, dû soit à une production insuffisante, soit à une évaporation excessive des larmes :
Il existe donc deux formes physiopathologiques distinctes et non exclusives du syndrome de l’œil sec:
La forme aqua-déficiente (sécrétion insuffisante des larmes)
La sécheresse oculaire par carence aqueuse se produit lorsque les glandes lacrymales principales sont altérées et incapables d’humidifier l’œil.
2. La forme évaporative (évaporation excessive des larmes)
La majorité des cas d’œil sec sont de forme évaporative, principalement causés par l’absence ou l’insuffisance de la couche lipidique externe du film lacrymal, couche sécrétée par les glandes meibomiennes.
L’œil sec par évaporation se produit lorsque les glandes meibomiennes sont défectueuses, lorsque la surface oculaire est irrégulière, lorsque la structure des paupières est anormale ou lorsque des lentilles de contact sont portées, par exemple. La blépharite meibomienne appartient à la forme évaporative de l’œil sec et est liée au blocage des glandes de Meibomius (ou glandes tarsiennes). Ces glandes, situées dans les paupières inférieures et supérieures, sont responsables de la production de la couche lipidique du film lacrymal. Lorsque ces glandes présentent un dysfonctionnement, la couche lipidique devient insuffisante pour prévenir l’évaporation du film lacrymal et fournir la lubrification de la surface.
La forme « évaporative » représente 65% à 86% des patients affectés par le syndrome de l’œil sec. L’E-Eye est destiné aux patients souffrant de la forme évaporative de la blépharite meibomienne.
Démontrer et évaluer l’innocuité et l’efficacité d’un dispositif de lumière pulsée de dans le traitement du dysfonctionnement des glandes de Meibomius et évaluer l’innocuité et l’efficacité de la lumière pulsée.
Ces études sont basées sur différentes données : analyse des rapports médicaux, tests d’E-Eye. Plusieurs études ont ainsi été menées, notamment en Australie, en Nouvelle-Zélande, en Chine, …
Traitement avec un dispositif polychromatique à lumière pulsée pour un dysfonctionnement lié à une insuffisance dans la couche lipidique, Dr Christian Malbrel, Ophtalmologiste.
Essai prospectif de la lumière pulsée intense pour le traitement du dysfonctionnement des glandes meibomiennes. Jennifer P. Craig, Yen-Heng Chen, et Philip R. K. Turnbull, Ocular Surface Laboratory, Department of Ophthalmology, New Zealand National Eye Centre, University of Auckland, Auckland, Nouvelle-Zélande.
But
Évaluer l’effet de la lumière pulsée (IPL) appliquée à la zone péri-oculaire dans le traitement du dysfonctionnement des glandes meibomiennes (MGD) par le biais d’une étude prospective, en double aveugle, avec contrôle par placebo.
Méthodologie
Vingt-huit participants ont subi un traitement IPL (E-Eye, E-Swin, France), avec des impulsions lumineuses séquencées homogènes appliquées à la zone péri oculaire d’un œil et un traitement placebo à l’œil controlatéral témoin à 1, 15 et 45 jours après l’évaluation de base (BL). L’évaluation de la couche lipidique (LLG), le temps de rupture du film lacrymal (NIBUT), le taux d’évaporation des larmes (TER), la hauteur du ménisque lacrymal (TMH) et l’évaluation subjective des symptômes (VAS) ont été comparés à chaque visite avec les valeurs initiales obtenues lors de la première évaluation.
Résultats
La qualité de la couche lipidique s’est améliorée de façon significative de J0 au jour (J) 45 dans l’œil traité (P< 0,001) contrairement à l’œil témoin (P = 0,714), avec 82% des yeux traités s’améliorant d’au moins un LLG. Le temps de rupture du film lacrymal (NIBUT) s’est également amélioré de façon significative, passant de J0 à J45 dans l’œil traité (P < 0,001) contrairement à l’œil témoin (P = 0,056); il était significativement plus long dans l’œil traité à D45 (14,1 ± 9,8 secondes contre 8,6 ± 8,2 secondes, P < 0,001). Le taux d’évaporation des larmes n’était pas différent entre l’œil traité et l’œil témoin à chaque visite. La hauteur du ménisque lacrymal n’a pas évolué dans l’un ou l’autre œil (P > 0.05). Le score d’évaluation subjective s’est amélioré à partir de J0 dans l’œil traité (P < 0,015), mais pas l’œil témoin (P = 0,245), avec 86% des participants notant des symptômes réduits dans l’œil traité à D45.
Conclusion
La lumière pulsée intense avec de multiples impulsions structurées montre le potentiel thérapeutique pour le traitement de la MGD, en améliorant la qualité de film lacrymal et réduisant les symptômes de l’œil sec. (www.aczctr.org.au numéro, ACTRN12614000162617.)
Cette étude a été menée avec un dispositif médical E-Eye, identique dans tous les aspects (paramètres, caractéristiques physiques) aux appareils E-Eye actuellement fabriqués et commercialisés.
La personne responsable de cette étude était Jennifer P. Craig, une optométriste universitaire internationalement reconnue. Ses principaux travaux de recherche portent sur l’œil sec, les dysfonctionnements du film lacrymal, la surface cornéenne, le port des lentilles de contact et la chirurgie réfractive. Elle dirige actuellement le « Ocular Surface Laboratory » de l’Université d’Auckland et donne régulièrement des conférences de formation continue et de recherche à l’échelle internationale, ainsi que des publications dans la presse scientifique et clinique. Elle a mené cette étude avec les Drs Turnbull et Chen. L’essai clinique a été enregistré à l’ANZCTR (Australian New Zealand Clinical Trials Registry) sous la demande 365741 et est disponible via ce lien :
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365741
Évaluation de l’innocuité et de l’efficacité d’un dispositif de lampe flash au xénon à décharge contrôlée dans le traitement de l’œil sec provoqué par le dysfonctionnement des glandes de Meibomius, Dr Huibin Lv, troisième hôpital universitaire de Pékin.
But
L’inflammation chronique de la surface oculaire, provoqué par le dysfonctionnement des glandes meibomiennes, est très commun dans la clinique ophtalmologique. Le but de cette étude est d’évaluer une nouvelle méthode – dispositif de lampe flash au Xenon à décharge contrôlée – dans le traitement du syndrome d’œil sec provoqué par le dysfonctionnement des glandes meibomiennes, son efficacité et sa sécurité.
Équipement
Une machine E-Eye a été fournie par E-Swin, France (www.e-swin.com).
Patients
Les patients ont été inclus à l’étude de juillet 2014 à octobre 2014, au troisième hôpital universitaire de Pékin. Les critères d’inscription et d’exclusion sont indiqués au tableau 1. Pour le diagnostic, le syndrome d’œil sec devait avoir persisté pendant au moins 12 mois, et le temps de rupture de film lacrymal (TBUT) devait être de moins de 10s, tandis que l’obstruction des orifices des glandes meibomiennes devrait être supérieure ou égale au grade 1. Pour le groupe de traitement, tous les patients ont eu 4 visites : première visite, puis 2 semaines, 1 mois et 2 mois après la première visite. Le dispositif de lampe flash au Xénon à décharge contrôlée a été appliqué aux patients à chaque visite (énergie 13.0J/cm2).
Critères généraux d’inclusion et d’exclusion de l’étude
Inscription :
Exclusion :
Évaluation clinique
L’évaluation clinique comprenait : (1) l’évaluation du syndrome des yeux secs, (2) la paupière (épaississement palpébral, plaies, anomalies vasculaires, anomalies des cils, hyperkératose, blépharite antérieure), (3) glande meibomienne (nombre de glandes sur une longueur de 1 cm au centre, degré d’obstruction, cicatrice, absence de l’orifice, nature de la sécrétion), (4) film lacrymal (BUT, débris, mousse, hauteur des ménisques lacrymaux supérieur et inférieur), (5) cornée et conjonctive (hyperémie conjonctivale, coloration cornéenne).
Statistiques
Pour l’évaluation des symptômes, les glandes meibomiennes (quantité présente en zone centrale de 1cm, degré d’obstruction, dégénérescence, sécrétion glandulaire, film lacrymal (BUT), débris, mousse, hauteur des ménisques lacrymaux supérieur et inférieur), cornée et conjonctive (congestion conjonctivale, coloration cornéenne, relâchement conjonctival), les scores ont été analysés à l’aide du test de Chi 2. Pour l’évaluation de la paupière (épaississement palpébral, plaie, anomalies vasculaires, anomalies des cils, hyperkératose, blépharite antérieure) et des glandes meibomiennes (cicatrice), le test de chi 2 a été utilisé.
Résultats
Caractéristiques démographiques : L’étude a évalué 40 patients ayant des yeux secs soit 80 yeux, dont 22 patientes (44 yeux) et 18 patients masculins (36 yeux). L’âge moyen des patients était de 51,3 + 20,1 ans (gamme 21-78 ans).
Conclusion
En utilisant le traitement de la lampe flash au Xénon à décharge contrôlée (niveau d’énergie : 13.0J/cm2), les symptômes d’œil sec ont été soulagés d’une manière significative chez les patients dont la pathologie de l’œil sec était liée à un dysfonctionnement des glandes meibomiennes, de même que la morphologie du bord palpébral, l’obstruction des méats des glandes meibomiennes et la quantité de sécrétion meibomienne ont également été améliorées. Toutes les différences entre avant et après traitement étaient statistiquement significatives. En outre, la thérapie par lampe flash au Xénon à décharge contrôlée a amélioré la qualité de résistance du film et prolongé le temps de rupture du film. Après 4 traitements consécutifs, l’amélioration des symptômes d’œil sec et la qualité des structures oculaires ont pu facilement être conservées. Dans l’ensemble, cette étude a démontré que le traitement par lampe flash au Xénon à décharge contrôlée est sûr et efficace dans le traitement de l’œil sec provoqué par le dysfonctionnement des glandes meibomiennes.
L’efficacité du traitement de la lampe flash au Xénon à décharge contrôlée était statistiquement significative pour tous les symptômes, sauf la vision floue, tandis que les tendances d’amélioration étaient semblables à d’autres signes. Dans cette analyse, 13 symptômes ont été sélectionnés ; chacun d’eux a été mis à l’échelle de 0 à 10 avec 0 ce qui signifie aucun symptôme et 10 très grave. Au cours de chaque visite, on a demandé au patient d’auto-évaluer les 13 symptômes, et toutes les évaluations ont été documentées.
Avec le tearstim, un deuxième dispositif dédié au marché des soins optiques est disponible, le nouveau concept marketing pour les opticiens est également lancé :
Accompagnant E-Swin, Petra Bruckmüller a repris le poste du fondateur, pour gérer l’entreprise en mettant l’accent sur le développement international et la mise en œuvre de nouveaux concepts de produits uniques.
Après 2 ans de développement international du département vision, ESW Vision a été fondée en tant que business unit dédiée au développement de concepts marketing et à la distribution de la gamme de produits pour le marché de l’ophtalmologie et de l’optique.
Les procédures d’enregistrement E-Eye sur les principaux marchés sont achevées. Prêt pour l’international …
Ce nouvel appareil a été spécialement certifié pour le traitement de la MGD (dysfonctionnement des glandes meibomiennes).
Pré-lancement en Australie/Nouvelle-Zélande dans les premiers 18 mois.
Le département de recherche et développement d’E-Swin est créé. Une équipe d’ingénieurs et de développeurs logiciel est constituée. Le savoir-faire disponible au sein de ce département est dédié à l’innovation.
Fondation d’E-Swin par le Dr Yves Vincent Brottier
Generell sind trockene Augen das Ergebnis eines Tränenschicht-Problems, das entweder durch unzureichende Tränenproduktion oder übermäßige Verdunstung der Tränen verursacht wird:
Es gibt also zwei unterschiedliche und nicht ausschließliche pathophysiologische Formen des Trockene Augen Syndroms:
1. Die Aqua-defiziente Form (unzureichende Tränensekretion)
Augentrockenheit durch Feuchtigkeitsmangel tritt auf, wenn die Tränendrüsen verändert sind und nicht in der Lage sind, das Auge zu befeuchten.
2. Die Verdunstungsform (übermäßige Verdunstung der Tränen)
Heutzutage ist man sich weithin einig, dass eine große Mehrheit der Fälle von der Verdunstung verursacht werden, vor allem durch das Fehlen oder Unzulänglichkeit der externen Lipidschicht des Tränenfilms von der Meibom-Drüsen.
Verdunstung und trockene Augen treten auf, wenn die Meibomdrüsen defekt sind, wenn die Augenoberfläche unregelmäßig ist, wenn die Augenlidstruktur abnormal ist oder wenn Kontaktlinsen getragen werden. Meibom Blepharitis gehört zur Verdunstungs-Form vom trockenen Auge und wird durch Verstopfung der Meibomdrüsen (oder tarsalen Drüsen) verursacht. Diese Drüsen, in den unteren und oberen Augenlider, sind für die Herstellung der Lipidschicht des Tränenfilms verantwortlich. Wenn die Drüsen blockiert sind, ist die Lipidschicht unzureichend bei der Verhinderung der Verdunstung des Tränenfilms und einer Schmierung der Oberfläche.
Die Verdunstungsform dieser Erkrankung befällt 65% bis 86% der Patienten, die von trockenen Augen betroffen sind. E-Eye ist für Patienten gedacht, die an der Verdunstungsform von Meibom Blepharitis leiden.
Das Ziel dieser Studie war es, die Auswirkungen von Intense Pulsed Light in der Behandlung der Meibom-Drüsen-Dysfunktion zu demonstrieren und um die Sicherheit und Wirksamkeit einer gepulsten Lichtbehandlungsvorrichtung beim Meibom-Drüsen-Dysfunktion zu bewerten.
Diese Studie wurde anhand verschiedener Daten durchgeführt: Analyse der Krankenakten, E-Augentests, klinische Studie des E-Eye in Australien und Neuseeland, und einer weiteren klinischen Studie in China.
Die Behandlung mit einer vielfarbigen gepulsten Lichtvorrichtung für “trockenes Auge” in Form eines Hornhautzustand mit einem Mangel in der Lipidschicht – Dr. Christian Malbrel, Augenarzt.
Prospektive Studie von Intense Pulsed Light für die Behandlung der Meibom-Drüsen-Dysfunktion. Jennifer P. Craig, Yen-Heng Chen, et Philip R.K. Turnbull, Augenoberflächen-Labor, Augenklinik des New Zealand National Augenzentrums, University von Auckland, Auckland in Neuseeland.
Zweck
Die Wirkung von Intense Pulsed Light (IPL) auszuwerten über eine prospektive, doppelblinde, Placebo-kontrollierte, gepaarte Augen-Studie, um die Periokularregion bei der Behandlung von Meibom-Drüsen-Dysfunktion (MDD).
Methodik
Achtundzwanzig Teilnehmer unterzogen sich einer IPL-Behandlung (E-Eye, E-Swin, Frankreich) mit homogen sequenzierten Lichtpulsen der Periokularregion eines Auges und Placebo-Behandlung am Partner Kontroll-Auge bei Tag 1, 15 und 45 nach Studienbeginn (BL). Lipidschicht-Grad (LLG), nicht-invasive Tränenabrisszeit (NIBUT), Tränenverdampfungsrate (TER), Tränenmeniskushöhe (TMH) und subjektiver Symptom-Score mit visuellen Analogskalen (VAS) wurden bei jedem Besuch mit BL und Kontrollwerten verglichen.
Resultate
Der Lipidschicht-Grad verbesserte sich deutlich von BL zu Tag (T) 45 in dem behandelten Auge (P < 0,001), aber nicht im Kontrollauge (P = 0,714), mit 82% der behandelten Augen mit mindestens einem LLG. Nicht-invasive Tränenabrisszeit verbesserte sich auch deutlich von BL auf T45 in dem behandelten Auge (P < 0,001), aber nicht im Kontrollauge (P = 0,056); es war signifikant länger im behandelten Auge T45 (14,1 ± 9,8 Sekunden im Vergleich zu 8,6 ± 8,2 Sekunden, p < 0,001). Die Tränenverdampfungsgeschwindigkeit war im behandelten Auge nicht anders als im Kontrollauge. Die Tränenmeniskushöhe änderte sich nicht vom BL in beiden Augen (p > 0,05). Der visuelle Analogskala Symptom-Score von BL verbesserte sich im behandelten Auge (p < 0,015), aber nicht im Kontrollauge (p = 0,245), wobei 86% der Teilnehmer reduzierte Symptome im behandelten Auge von T45 feststellten.
Fazit
Intense Pulsed Light mit mehreren geformten Impulsen zeigt therapeutisches Potenzial für MDD, die Verbesserung der Tränenfilmqualität und Verringerung der Symptome des trockenen Auges. (www.anzctr.org.au Nummer: ACTRN12614000162617.)
Diese Studie wurde mit einem E-Eye durchgeführt, das in allen Aspekten (Einstellungen, physikalische Eigenschaften) identisch mit E-Eye Geräten ist, die derzeit hergestellt und vermarktet werden.
Die Verantwortliche der Studie war Jennifer P. Craig, eine qualifizierte akademische Augenärztin. Ihre Forschungsschwerpunkte sind: trockene Augen und Tränenfilmstörungen, Hornhaut, Kontaktlinsen und refraktäre Chirurgie. Sie leitet derzeit das Augenoberfläche-Labor an der University von Auckland und liefert regelmäßig internationale Weiterbildungen und Forschungs-Vorträge , sowie Publikationen in der wissenschaftlichen und klinischen Presse. Sie führte diese Studie mit Dr. Turnbull und Dr. Chen durch. Die klinische Studie wurde bei ANZCTR (Australian New Zealand Clinical Trials Registry) unter der Auftragsnummer 365741 registriert und ist über diesen Link verfügbar: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365741
Bewertung der Sicherheit und Wirksamkeit der kontrollierten Entladung der Xenon-Blitzlampe in der Behandlung des trockenen Auges durch Dysfunktion der Meibomschen Drüsen – Dr. Huibin Lv, Peking University Third Hospital Eye Center.
Zweck
Chronisch entzündliche Augenoberfläche des trockenen Auges, durch Dysfunktion der Meibomschen Drüsen ist sehr häufig in der Klinik. Der Zweck dieser Studie ist es, ein neues Verfahren zu bewerten – Kontrollierte Entladung der Xenon-Blitzlampe – bei der Behandlung von Keratoconjunctivitis sicca verursacht durch Dysfunktion der Meibomschen Drüsen, deren Wirksamkeit und Sicherheit.
Ausrüstung
Ein E-Eye Gerät wurde von E-Swin, Frankreich (www.e-swin.com) zur Verfügung gestellt.
Patienten
Die Patienten wurden in der Studie von Juli 2014 bis Oktober 2014 eingeschrieben im Third Hospital der Peking-Universität. Die Kriterien für Einschreibung und Ausschluss sind in Tabelle 1 gezeigt. Zur Diagnose sollte das trockene Auge-Syndrom für mindestens 12 Monate bestehen, und die Tränenfilmaufrisszeit (TBUT) sollte weniger als 10s betragen, während die Öffnung der Meibomschen Drüsen Obstruktion größer als oder gleich Grad 1 sein sollte. Für die Behandlungsgruppe hatten alle Patienten 4 Besuche: erster Besuch, dann 2 Wochen, 1 Monat und 2 Monate nach dem ersten Besuch. Die kontrollierte Entladung der Xenon-Blitzlampe wurde für den Patienten bei jedem Besuch (Energie 13,0J / cm²) verwendet.
Allgemeine Kriterien für die Einschreibung und Ausschluss aus der Studie
Einschreibung
Ausschluss
Klinische Bewertung
Klinische Bewertung beinhaltet: (1) Bewertung des Syndroms des trockenen Auges, (2) Augenlid (Augenlidstumpf, Kerbe, Gefäßanomalien, Wimpern-Anomalien, Hyperkeratose, Front-Blepharitis), (3) Meibom-Drüsen (Quantität an zentralem 1 cm, Grad der Obstruktion, Narbe, Fehlen von Öffnung, Art der Sekretion), (4) Tränenfilm (BUT, Verunreinigung, rissiger Schaum, Höhe des oberen und unteren Tränenfluss), (5) Horn- und Bindehaut (konjunktivale Hyperämie, konjunktivale Schlaffheit, Verfärbung der Hornhaut).
Statistiken
Für die Auswertung der Symptome, Meibom-Drüsen (Quantität von zentralem 1 cm, Grad der Behinderung, Fehlen, Drüsensekret, Tränenfilm (BUT), Verunreinigung, Tränen-Schaum, Höhe des oberen und unteren Tränenfluss), Hornhaut und Bindehaut (Konjunktiva Staus, Hornhautfärbung, Bindehautentspannung) wurden Wertungen mit paarweisen Tests analysiert. Für die Auswertung des Augenlids (Augenlidstumpf, Kerbe, Gefäßanomalien, Wimpernanomalien, Hyperkeratose, Front-Blepharitis) und Meibom-Drüsen (Narbe) wurde der Chi-Quadrat-Test verwendet.
Resultate
Demographische Merkmale: Die Studie untersuchte 40 Patienten mit trockenem Auge mit 80 Augen, darunter 22 weibliche Patienten (44 Augen) und 18 männliche Patienten (36 Augen). Das Durchschnittsalter der Patienten betrug 51,3 + 20,1 Jahre (Bereich 21 bis 78 Jahre).
Fazit
Bei Verwendung kontrollierter Entladung der Xenon-Blitzlampe (Energieniveau: 13.0J / cm²), wurden die Symptome des trockenen Auges signifikant bei Patienten mit Meibom-Drüsen-Dysfunktion entlastet, und die Morphologie des Lidrands, Meibom-Drüsen Öffnungs-Obstruktion und Meibom-Drüsen Quantität wurden ebenfalls verbessert. Alle Unterschiede zwischen Vor- und Nachbehandlung waren statistisch signifikant. Darüber hinaus hat die kontrollierte Entladung der Xenon-Blitzlampe eine Verbesserung der Tränenfilmqualität und Verlängerung der Tränenabrisszeit gezeigt. Nach 4 aufeinanderfolgenden Behandlungen konnte die Verbesserung der Symptome des trockenen Auges und das Augengewebe leicht aufrechterhalten werden. Insgesamt hat diese Studie gezeigt, dass die kontrollierte Entladung der Xenon-Blitzlampe sicher und wirksam bei der Behandlung von trockenem Auge von Meibom-Drüsen-Dysfunktion ist.
Die Wirksamkeit der kontrollierten Entladung der Xenon-Blitzlampe war statistisch signifikant für alle Symptome außer Sehstörungen, während die Verbesserungstrends ähnlich wie andere Zeichen waren. Bei dieser Analyse wurden 13 Beschwerden ausgewählt; jede von ihnen wurde von 0 bis 10 mit 0 für kein Symptom und 10 für sehr ernstes Symptom bewertet. Bei jedem Besuch wurde der Patient gebeten, sich selbst zu bewerten und alle Auswertungen wurden dokumentiert.
Alle unsere aktuellen Studien finden Sie unter www.esw-vision.com/press-releases
Mit tearstim kommt ein zweites Gerät zur Anwendung bei trockenen Augen auf den Markt. Speziell entwickelt für Optiker. Auch das neue Augen-Service-Konzept wird eingeführt.
mit fast 10 Jahren Erfahrung in der Geschichte von E-Swin, übernimmt Petra BRUCKMUELLER die Position des Gründers, um das Unternehmen mit dem Schwerpunkt auf der internationalen Weiterentwicklung und Implementierung neuer, einzigartiger Produktkonzepte zu leiten.
Nach 2 Jahren internationaler Entwicklung der Vision-Abteilung wurde ESW Vision als Start-up-Geschäftseinheit gegründet, die sich der Entwicklung von Marketingkonzepten und dem Vertrieb der Produktlinie für den Augenpflegemarkt widmet
Die Registrierungsverfahren für E-Eye in wichtigen Märkten sind geschlossen. Bereit für den internationalen Markt …
Nach mehr als drei Jahren Entwicklungszeit wird die erste Behandlungs-Technologie für Erkrankungen des trockenen Auges eingeführt und kann dem Weltmarkt vorgestellt werden. Die ersten 1,5 Jahre sind für die Voreinführung in Australien / Neuseeland reserviert.
Ein Team aus Ingenieuren und Softwareentwicklern wird gebildet. Das spezialisierte Know-how ist bereit, den nächsten Innovationsschritt „intern“ zu entwickeln.
Ein außergewöhnlicher Schritt, um Visionen in die Realität umzusetzen.
E-Eye registration procedures in major markets are closed. Ready to go international …
Hyperpigmentations (or blemishes) are localised scars resulting from an imbalance in melanin production that cannot be repaired by skin cells. This melanin production is regulated by a complex hormonal mechanism; it’s very sensitive to stress, to certain medications, to the use of perfume and to anything that can cause endocrinal imbalance – not forgetting environmental factors like sunlight.
These lesions are mainly found on exposed areas: face, décolletage, forearms and hands. They often appear after middle age on the back of the hands and face. Contraceptive pills or pregnancy can trigger fairly large, brown hyperpigmentation on the forehead and cheekbones, which is accentuated by the sun.
The most common disorders are actinic lentigines. Pigmented lesions can be superficial, limiting themselves to the epidermis; others are deeper because they’re anchored in the dermis. These are more difficult to remove as they represent a specific type of melasma.
The medical claim for P-O75 is for the treatment of flat and benign cutaneous pigmented blemishes.
Before any treatment, it’s important to make sure that the pigmented lesions are benign.
Different techniques are used to reduce inflammatory scarring or to revive stagnant cicatricial processes; pulsed light is one of the treatments that respond to this process.
P-O75 can be used to treat:
P-O75 is not designed to establish a medical diagnosis, but to treat the conditions described above.
P-075’s characteristics mean that it’s possible to select only a portion of the light spectrum emitted by a flash tube at the moment of flashing. This is achieved by interposing one or more filters between the tube and the skin.
Optimum filtration provides a spectrum of light that’s absorbed selectively by the target (the melanin of the lesions) to the exclusion of the natural skin melanin.
P-O75 has a filtration system adapted to the clinical condition being treated.
Taking into account the absorption spectra of all the elements that constitute skin, it’s necessary to keep the wavelengths <420 nm when applied to pigmentary defects.
Finally, as also explained in the technical manual, P-O75’s flash duration is determined by the treated target and correlates with the perfect homogeneity of the luminous intensity of the emitted flash.
Clinical evaluation was based on:
Pulsed light has been used for 20 years, either alone or in conjunction with other techniques or medication to treat minor ailments or disorders such as: hirsutism and hairiness, wrinkles, pigmented lesions, vascular lesions.
The light produced by pulsed light devices is absorbed by melanin (hairiness, pigmented lesions), by water in the dermis (sagging) or by haemoglobin (vascular lesions). The light energy is then converted into thermal energy, which – depending on the temperature reached – can:
Just like with laser, IPL dims pigmented lesions by destroying the excess melanin they contain. However, treatment of pigmented lesions by pulsed light is more effective than other treatments (depigmentation creams, cryotherapy, chemical peels) because it protects the surrounding skin; follow-ups are especially light. Another advantage of pulsed light is the much larger treatment surface than with laser, allowing faster treatment of a set of lesions, for example; side effects are also much less than those linked to laser.
Safety is checked at several levels:
P-O75’s flash duration is determined in relation to the treated target (the melanin), and is correlated with the perfect homogeneity of the luminous intensity of the emitted flash.
Optimum filtration provides a spectrum of light that’s absorbed selectively by the target.
The chance of reduced performance has only one possible source: insufficient flash power. The cause is an incorrect setting on the device during manufacturing: set to a lower power.
This point is checked by the Production team, who will adjust the level of energy delivered if necessary. In particular, the instruction “Verification and settings of P-O75” describes the elements to be controlled during production, including the energy adjustment mode.
Each P-O75 is set to ensure a strong enough current to guarantee the effectiveness of the flash.
Literature on the effectiveness and safety of pulsed light to treat pigmentary disorders is numerous and has been regularly published over the last 15 years.
In particular, it is safe and effective for the treatment of benign pigmentary disorders, including conditions treated by P-O75.
Also, the literature shows that treatment for pigmented lesions and skin ageing are generally related. P-O75 treats areas of the face, hands and décolletage. In the vast majority of cases, pigmented lesions found on these 3 areas are solar lentigines due to excessive sun exposure resulting in premature ageing of the skin.
Side effects are almost always systematic. However, they are bearable and temporary (there has never been any scarring), so the benefits of using the device outnumber the disadvantages.
When the lesions are dark and/or acquired, pulsed light produces excellent results in 1 or 2 sessions. There is no social exclusion. Lesions reappear over time and treatment can then be renewed. However, the best way to avoid recurrences is to avoid exposure to the sun.
Finally, the need to properly identify the type of pigmented lesion beforehand is also highlighted. For this reason, E-Swin has decided to make P-O75 available only to doctors, who will then be able to make a preliminary diagnosis. Doctors are indeed in the best position to check pigmented lesions prior to treatment.
In addition, P-O75 meets the electrical safety and performance specifications that have been indicated.
Above all, it was designed and will be manufactured according to electrical safety and electromagnetic compatibility standards, 60601-1 and 60601-1-2 respectively.
The records for P-O75 risk management conclude that, given the risk reduction achieved after application of risk control measures, in addition to the low level of residual risks, and considering the safety measures (including power limitation, filtration, anti-tamper system), this analysis has made it possible to implement risk control measures during the design and assembly phases. These measures have helped to reduce the identified risks to an acceptable level.
A number of these risks (although classified as acceptable) are subject to a series of warnings in the user manual; each warning is easily identifiable when reading the user manual by its logo, as defined by the standard.
The user manual contains the medical claim, the risks, how to use P-O75 and contraindications.
P-O75 enables fast and effective results. An additional session can be performed if needed, but only after a 10-day interval. This protocol is also explained in the user manual.
Scars are the result of an unpredictable “disorder” occurring during the healing process, whether from a “clean” surgical scar or post-traumatic scar.
Different techniques are used to reduce inflammatory scarring or to revive stagnant cicatricial processes; pulsed light is one of the treatments that respond to this process.
When a post-surgical scar occurs, collagen fibres, blood vessels, nerve endings and muscle fibres are partially destroyed. The body therefore triggers a series of reactions:
The process evolves over several months, between 6 and 36 months depending on individual cases, before the final and lasting appearance of a scar is determined.
Scarring varies from one individual to another because it largely depends on nutritional (malnutrition), metabolic, endocrinal and medicinal (prolonged use of corticosteroids) factors. Age is also an important factor, as is skin colour; this can have an impact on the appearance of the scar, which can be keloid and may well feature a protuberance.
The aim of our study was to verify the impact of treatment using the W-O75 pulsed light device on target cells and to measure the decrease in side effects linked to the cicatricial process.
Due to W-O75’s characteristics, it’s possible to select just a portion of the light spectrum emitted by a flash tube at the moment of flashing. This is achieved by interposing one or more filters between the tube and the skin.
Optimum filtration provides a spectrum of light that’s absorbed selectively by the target area (fibroblast) – producing collagen, hyaluronic acid and elastin.
W-O75 has a filtration system adapted for the clinical indication being treated.
In addition, near infrared rays such as those emitted by W-O75 are already clinically used today in numerous applications that aim to improve skin quality, including the stimulation of endogenous collagen synthesis. In fact, infrared light significantly raises the temperature of tissue fluid, which is the effect of this application.
Finally, W-O75 has a flash duration determined by the treated target (fibroblasts), and is in correlation with the perfect homogeneity of the luminous intensity of the emitted flash.
Pulsed light has been used for 20 years, either alone or in conjunction with other techniques or medication, to treat minor ailments or skin disorders such as hirsutism and hairiness, wrinkles, scar tissue and pigment disorders.
The light produced by pulsed light devices is absorbed by melanin (hairiness) or by haemoglobin (wrinkles, scars). The light energy is then converted into thermal energy, which, depending on the temperature reached, can:
With E-One then E-O75, E-Swin has used pulsed light to treat hirsutism and hairiness in general. E-O75’s foundation has been used to create W-O75 by changing the HMI (Human Machine Interface).
The test was carried out with W-O75, using the same parameters as the mass-produced E-Swin devices: operating principle, settings, and identical optical, electronic and mechanical characteristics. It’s therefore a medical device entirely equivalent to the one currently marketed.
E-Swin deliberately chose to conduct its clinical study in vitro (cell culture) to measure W-O75’s performance, so that the results of this study would not be open to criticism. Indeed, published studies are usually performed on individuals and the performance demonstrated through before/after pictures. However, this method is questionable because the pictures can be edited afterwards or photos can be taken in different conditions: angle, light, etc.
A summary of the clinical study of W-O75
The only way to conclusively measure the performance of W-O75 was to measure, in vitro, changes in the following 3 parameters:
Several flash configurations were tested, and it was found that one stood out more than the others in increasing the production of collagen I, elastin and glycosaminoglycans. We chose this configuration for W-O75.
Only one patient was selected – a female patient in this instance – to sample cells because fibroblasts within the base of wrinkles are identical, irrespective of the person. Therefore it wasn’t necessary to select different people in order to have different sources for fibroblasts within the base of wrinkles.
Fibroblasts within the base of wrinkles are present in everyone from adulthood. However, they’re found in much larger amounts in the elderly. The choice finally fell on a 64-year-old – the most favourable age group for a rich sample of this type of cells.
This device requires prior training for professional use. The training covers two separate areas: the principles of pulsed light and its action on the target, and how to use the device.
The treatment’s safety was checked for skin types I to IV.
We note the characteristics of the energy implemented with W-O75, in comparison to a certified medical device that’s already been marketed for over 1 year for the treatment of hirsutism (E-O75). Luminous energy is distributed throughout the duration of the flash with W-O75. Thus, with a higher fluency than E-O75, the instantaneous luminous power delivered onto the skin, across the entire flash, is actually almost 4 times lower than that used in hair removal with E-O75.
The test conducted with W-O75 (identical to that marketed) also demonstrates the benefit of flashes on several types of cells:
In addition to establishing the optimal pulse duration, this test enabled operational safety at maximum power to be checked.
Finally, the risk of overheating or even burning was also taken into account and assessed during the risk analysis. No unacceptable risk was identified after control measures were applied.
The test demonstrated:
The technology behind W-O75, as demonstrated on fibroblasts, increases the secretion of these 3 elements. As these 3 elements are heavily involved in post-surgical wound healing, an increase in their secretion will therefore bring about a welcome improvement in the healing process.
Hirsutism is an abnormal manifestation of androgenic hormones, either due to excessive production (hyperandrogenicity) or abnormal skin sensitivity (so called “idiopathic hirsutism”). There is also pathological hypertrichosis; this is usually genetic, sometimes with a hormonal component, and can occur in both men and women. In women, hirsutism implies the presence of hair on specific areas of the body where it normally only grows on men. These areas include: upper lip, chin, cheeks, chest. Treatments are cosmetic (discolouration of hair and hair removal by various means, including waxing, electric (electrolysis), laser or pulsed light) and sometimes via medication (combined oral anti-androgen therapy).
Hair removal treatment, however, is essential if complete results are to be obtained.
The aim of the evaluation was to assess the effectiveness and safety of the treatment. To do this, this study based itself on various data: clinical trials, a satisfaction survey, a study report and bibliographic research.
Tests were conducted with E-One on 63 people in Sabouraud Health Centre (Hôpital Saint Louis – Paris) and the Laboratory ATS / Eurofins (Marseille) between 2008 and 2011.
Summary of comments
This 3-year study helps demonstrate the sustainability of long-term treatment with E-One (3 years), as well as its safety.
Efficiency was demonstrated in relation to the conventional reference method: hot wax.
Tolerance was also checked. The appearance of erythema varies little from year to year: 5.2% (1st year), 3.7% (2nd year) and 3.4% last year, and remains weak.
No side effects were reported during the study.
This test has also been the subject of a publication in June 2010, in the Journal of Cosmetic Dermatology, “Randomized study of tolerance and efficacy of a home-use intense pulsed light (IPL) source compared to the hot-wax method “, Hertsel Adhoute, et al. (Periodical WILEY, Inc.), accessible via this link: : http://www.scimagojr.com/journalsearch.php?q=4000151101&tip=sid
Some users chose E-One for the treatment of hirsutism, in combination with or without drug treatment.
Methodology and sequence
Because of the difficulty in obtaining testimonials from users, E-Swin sent an “anonymous satisfaction questionnaire on hirsutism” to all of its customers in 2009, inviting those with hirsutism to respond.
Customers who replied
589 people suffering from hirsutism and using E-One responded to the questionnaire.
Customers under medical treatment
78% suffer from hormonal hirsutism.
Results
In terms of performance
The level of satisfaction (“satisfied” and “very satisfied”) reached 66% with E-One, compared to a rate of 44% for those who underwent sessions with a professional. A similar rate of satisfaction (63.3%) (“equally satisfied with E-One” and “more satisfied with E-One”) was reached for the 7% of clients receiving treatment, compared to sessions carried out by professionals. No claim of non-performance with E-One was noted.
In terms of security
No problems regarding the safety of the device were noted during the study.
Summary of key findings
“A study on the impact of flash exposure by a source of pulsed light (emitted by the device: E-One Clinic from E-Swin) developed for hair removal on tumorigenicity in a melanoma case” covering the period from 23 November 2012 to 7 December 2012, conducted by the CNRS.
Aim of the article
To check the lack of impact of pulsed light emitted by the E-One Clinic device on tumorigenicity in a melanoma case in mice.
The two lots were monitored in order to assess the difference in the development of tumours between those that were flashed and those that were not flashed.
Results
Flashing with E-One on melanoma tumours did not alter the growth of the tumours.
Key results
Tumour growth in the control mice and mice treated with E-One showed no significant difference. When a dose of flash is delivered, the study demonstrates a lack of inhibitory or accelerator effects on tumour proliferation; no evidence of intolerance was observed on healthy peri-tumoral skin exposed to the flash.
The data collected also shows the psychological consequences of successful treatment by pulsed light on hirsutism (improvement of self-esteem is higher than treatment by electrolysis).
As regards E-One, this was the first time that a device using pulsed light technology has been compared to a popular home hair removal method that’s considered to have a lasting effect: waxing.
Phase I of this study confirms the previous ones conducted in relation to using a device based on IPL. This particular study shows a better tolerance to E-One than to waxing. In all cases, the erythema that appeared remained light; it did not lead to oedema or desquamation. This indication was confirmed during Phase II, in terms of the appearance of erythema or the occurrence of any other side effect.
Thus, the second phase and third phase, during which only the E-One was used, confirms the 2 advantages of the device.
These results confirm the absence of irritating and lasting effects; slight redness lasted for over 24 hours (phase I of the study) in only 3% of cases. No erythema was observed after 24 hours. These effects are also similar to those typically observed in studies on the use of IPL: mild and reversible erythema.
Pulsed light deployed by E-One thus makes for a perfect hair removal tool for the treatment of hirsutism, even more so because prescription medication:
Hair removal therefore remains a necessity.
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