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Λιμνοπούλου Αλίκη - One of the best experts on this subject based on the ideXlab platform.
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Study of the safety and efficacy of the intracorneal Refractive Inlay Flexivue TM Micro-Lens (Presbia, CA Cooperatief U. A, Netherlands) for the correction of presbyopia
'National Documentation Centre (EKT)', 2014Co-Authors: Limnopoulou Aliki, Λιμνοπούλου ΑλίκηAbstract:Presbyopia (aging of accommodation mechanism of the human eye) represents a common problem for people aged over 40-45 years. Many theories have been proposed during the past decades regarding explanation of the pathologic physiology of presbyopia development. The most popular theory of those, states that presbyopia is the result of a progressive reduction of Lens ability to accommodate, that worsens with age, due to either Lens hardening or degeneration of the ciliary body tissues.Regardless of the responsible cause, presbyopia reduces the ability of near vision affecting everyday life of individuals. American studies have reported that in 1998, over 113 millions of Americans were over 45 years old, underlining the effect of presbyopia condition. A wide variety of procedures have been investigated by ophthalmologists to correct the refractive error. Cornea laser surgery with multifocal patterns or monovision approaches were developed including LASIK, PresbyLASIK,photorefractive keratectomy (PRK), laser epithelial keratomileusis (LASEK), thin-flap femto-LASIK or sub-Bowman’s keratomileusis (SBK). Conductive keratoplasty (CK), Clear Lens Extraction or cataract surgery using multifocal, pseudo-accommodative intraocular Lenses (IOLs) or monovision monofocal IOLs are also some of the techniques that have been used for the treatment of presbyopia.Cornea laser surgery and CK are minimal invasive methods, but they provoke irreversible changes at corneal anatomy, whereas scleral surgery and Clear Lens Extraction are more invasive techniques. The necessity to develop a minimal invasive, reversible, and safe surgical technique with an easy learning curve for patients between 45 and 60 years, who could be considered too old for presbyopia corneal laser surgery and too young for Lens Extraction, led to the development of refractive intracorneal Lenses (inlays) (Flexivue™ Micro-Lens) placed underneath cornea inside a pocket in the corneal stroma. The inlays are refractive Lenses that have a central zone free of refractive power and a peripheral zone with a standard positive refractive power. The inlays are inserted inside a pocket in the corneal stroma of the non dominant eye, offering two different focal points, one for the far vision and a different for the near vision respectively. The pocket of the cornea is created using a femtosecond laser.The Flexivue™ Micro-Lens is a transparent, hydrophilic disc with 3 mm diameter andapproximately 15 μm edge thickness. The central 1.6 mm diameter of the disc is planoand the peripheral zone has an add power. The base power available range from +1.5 D to +3.50 D in 0.25 D increments. At the center of the disc there is a hole of 0.15 mm diameter that permits the transfer of oxygen and nutrients of the cornea through the Lens. The Lens is implanted inside a pocket of the corneal stroma in the center of the visual axes of the non dominant eye.The Lens has a bifocal optical system which acts as a modified monovision (smartmonovision). During far vision the rays pass through the central zone of the inlay without refractive effect and will be sharply focused on the retina, whereas the rays which pass through the refractive peripheral zone will be not of focus in front of the retina.During near vision, the rays which pass through the central zone will be out of focusbehind the retina and the rays which pass through the Lens peripheral refractive zone will be focused on the retina. As a result, only the peripheral zone of the Lens provides the near vision correction, and affects far vision, whereas the central zone of the Lens and the peripheral unaltered part of the cornea do not affect the far vision.CLINICAL HYPOTHESISThe working clinical hypothesis for this study is that implantation of the Flexivue™Micro-Lens into a pocket created by femtosecond laser in the cornea, if correctly placed in the center of the cornea corresponding to the visual axes, will enable the study patients to obtain functional near vision without further correction while maintaining their distance.PURPOSE OF THE STUDY The purpose of this study is to evaluate the safety and efficacy of the Flexivue™ Micro- Lens for the treatment of presbyopia with enhanced medication regimen.STUDY POPULATIONFor the study, approximately 10 patients in each group will be enrolled at one location.To qualify for enrollment in this study, each candidate will be thoroughly evaluated toensure that they meet all inclusion criteria and that they do not exhibit any of theexclusion criteria specified in the study protocol.METHODSThis prospective, interventional clinical study comprised 47 emmetropic, presbyopes with a mean age of 51.55 years± 4.11 (range 45 to 60 years). The inlay was implanted, centred on the line of sight, inside a corneal pocket created in the non-dominant eye of the patients, using a femtosecond laser. Follow-up time was 12 months. Visual acuity, topography, wavefront aberrometry, contrast sensitivity, structural corneal alterations and questionnaires were evaluated.STUDY PARAMETERSEfficacy Measures: Uncorrected near visual acuity.Safety Measures: Best Corrected near visual acuity, BiomicroscopySatisfaction Measures: Patient satisfaction questionnaireRESULTS Twelve months after surgery, uncorrected near visual acuity (UNVA) was 20/32 or better in 75% of the operated eyes, whereas mean uncorrected distance visual acuity (UDVA) of the operated eyes was statistically significantly reduced (p
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Study of the safety and efficacy of the intracorneal refractive inlay "flexivue TM micro-Lens (Presbia, CA Cooperatief U. A, Netherlands)" for the correction of presbyopia
2014Co-Authors: Λιμνοπούλου ΑλίκηAbstract:Η πρεσβυωπία (φυσιολογική γήρανση του μηχανισμού της προσαρμογής) αποτελεί ένα κοινό πρόβλημα για τα άτομα ηλικίας άνω των 40 με 45 ετών. Αρκετές πιθανές θεωρίες έχουν προταθεί σχετικά με την παθολογική φυσιολογία για την ανάπτυξη της πρεσβυωπίας. Η πιο αποδεκτή είναι η σχετιζόμενη με την ηλικία μείωση της ικανότητας του κρυσταλλοειδούς φακού να προσαρμόσει, η οποία επιδεινώνεται προοδευτικά με την αύξηση της ηλικίας 1. Το γεγονός αυτό θα μπορούσε να προκληθεί είτε από την ηλικιακή σκλήρυνση του κρυσταλλοειδούς φακού, είτε από μεταβολές στον περιφακικό σάκο και το ακτινωτό σώμα σχετιζόμενες με ηλικιακές εκφυλίσεις των ιστών. Ανεξάρτητα τον μηχανισμό, η πρεσβυωπία μειώνει την κοντινή όραση. Όταν δε διορθωθεί μπορεί να επηρεάσει την ικανότητα του ατόμου για διάβασμα, τη συμμετοχή του σε διάφορες δραστηριότητες και τελικά την παραγωγικότητα του στην καθημερινή του ζωή 2. Είναι σημαντικό να τονισθεί η σημασία του φαινόμενου της πρεσβυωπίας και το πόσο αυτή επιδρά στην καθημερινή μας ζωή. Σε μελέτες που έγιναν στην Αμερική βρέθηκε ότι το 1998, περίπου 113 εκατομμύρια Αμερικανοί πολίτες ήταν σε ηλικία άνω των 45 ετών, ηλικία που αρχίζει να εμφανίζεται η πρεσβυωπία. Η θεραπεία της πρεσβυωπίας, παρόλο που είναι αποτελεσματική με την χρήση των θετικών διορθωτικών φακών για κοντινή όραση, έχει προκαλέσει το ενδιαφέρον των ερευνητών που έχουν προτείνει μια σειρά από χειρουργικές θεραπευτικές παρεμβάσεις. Η τοποθέτηση σκληρικών ενθεμάτων επέκτασης συνιστά μία χειρουργική τεχνική επιδίωξης αναστροφής της πρεσβυωπίας μέσω αύξησης της απόστασης της ακτινωτής απόφυσης από το σκληρό χιτώνα, με επακόλουθο την ανάκτηση μέρους της ελαστικότητας των ινών της ζιννείου ζώνης 3. Εναλλακτικά, αξιοποιείται η τεχνική της ‘μονο-όρασης’ (monovision), κατά την οποία ο κυρίαρχος οφθαλμός διορθώνεται με laser ή με τοποθέτηση μονοεστιακού ενδοφακού για την εξυπηρέτηση της μακρινής όρασης, ενώ ο έτερος για εκείνη της κοντινής. Ωστόσο, ο ασθενής συχνά αντιμετωπίζει σημαντικά προβλήματα στη διόφθαλμη όραση (όπως η μείωση του βάθους πεδίου και η απώλεια στερέοψης) 4-7. Ένας άλλος τρόπος διόρθωσης αυτού του περιοριστικού παράγοντα είναι με τη χρήση προσαρμοστικών ενδοφακών οι οποίοι ακολουθούν τις κινήσεις της προσαρμογής που υπόκειται ο σάκος του περιφακίου (στον οποίο είναι τοποθετημένοι) από το ακτινωτό σώμα. Αυτοί οι φακοί μπορούν να παρέχουν 0,5-1 διοπτρίες ‘ψευδο-προσαρμογής’8. Συγκριτικές μελέτες απέδειξαν ότι οι προσαρμοστικοί ενδοφακοί παρέχουν την ίδια, άνευ διόρθωσης, μακρινή οπτική οξύτητα, όμως χάνεται η δυνατότητα για κοντινή όραση μετά τους πρώτους έξι μήνες, εξαιτίας μείωσης της ελαστικότητας του περιφακίου (ανάπτυξη μετεγχειρητικών συμφύσεων) 9. Η χρήση πολυεστιακών ενδοφακών τελευταία έχει γνωρίσει ιδιαίτερη αποδοχή τόσο από τους ασθενείς όσο και από τους οφθαλμιάτρους. Ωστόσο και με αυτή τη μέθοδο παρατηρήθηκε μία σχετική μείωση των ποιοτικών χαρακτηριστικών της μακρινής και κοντινής οπτικής οξύτητας με (best spectacles corrected visual acuity-BSCVA)/χωρίς (uncorrected visual acuity-UCVA) διόρθωση καθώς και της ευαισθησίας στην φωτεινή αντίθεση 10, 11. 5 Οι χειρουργικές τεχνικές με τη χρήση laser στο επίπεδο του κερατοειδούς είναι μη αναστρέψιμες, καθώς μεταβάλλουν τη δομή του ιστού μέσω φωτοδιάσπασης, ενώ ο ασθενής ενδεχομένως να υποστεί μελλοντικά επιπλέον επέμβαση στους οφθαλμούς του για την αποκατάσταση του καταρράκτη. Οι χειρουργικές τεχνικές που αφορούν το σκληρό και τον κρυσταλλοειδή φακό, είναι πιο επεμβατικές και ακρωτηριαστικές για τους νέους πρεσβύωπες μέχρι 50 ετών στους οποίους ο φακός διατηρεί κάποιες εφεδρείες προσαρμογής. Έτσι, η επιστημονική κοινότητα αναζητά μία ελάχιστα επεμβατική και δυνητικά αναστρέψιμη χειρουργική τεχνική για τη διόρθωση της πρεσβυωπίας σε ασθενείς 45-55 ετών. Με βάση τα παραπάνω, η έρευνα για την διόρθωση της πρεσβυωπίας έστρεψε το ενδιαφέρον της εκ νέου στο επίπεδο του κερατοειδούς. Το τελευταίο, πολλά υποσχόμενο, επίτευγμα της επιστημονικής αυτής αναζήτησης είναι η κατασκευή ενδοκερατοειδικών διαθλαστικών ενθεμάτων 12. Το "FlexivueTM system" είναι μία τεχνική σχεδιασμένη να εισάγει ένα μικρού μεγέθους οπτικό φακό με θετική διαθλαστική δύναμη στο στρώμα του κερατοειδούς σε ένα σημείο ακριβώς απέναντι από το κέντρο της κόρης. Πρόκειται στην πραγματικότητα για ένα διπλοεστιακό φακό πάχους 15 μm και διαμέτρου 3 mm που τοποθετείται στον μη-επικρατούντα οφθαλμό. Λόγω της διπλοεστιακότητας του φακού η μακρινή όραση στο χειρουργημένο οφθαλμό επηρεάζεται πολύ λιγότερο από ότι με ένα κλασικό monovision. Με το φακό FlexivueTM τοποθετημένο, ο κερατοειδής γίνεται διπλοεστιακός. Το κεντρικό αναλλοίωτο τμήμα του κερατοειδούς οπού ο φακός είναι τοποθετημένος, προσφέρει ευκρινή μακρινή όραση και το περιφερικό τμήμα παρέχει ευκρινή κοντινή όραση. Κατά τη μακρινή όραση, οι φωτεινές ακτίνες του αντικειμένου που διέρχονται από την κεντρική plano ζώνη του ενθέματος και εκείνες που διέρχονται από την περιοχή του κερατοειδούς εξωτερικά του ενθέματος θα εστιαστούν στον αμφιβληστροειδή, ενώ οι ακτίνες του μακρινού αντικειμένου που διέρχονται από την περιφερική ζώνη του ενθέματος με τη διαθλαστική δύναμη θα εστιαστούν μπροστά από τον αμφιβληστροειδή και η θολή εικόνα που δημιουργούν θα απορριφθεί από το οπτικό σύστημα. Εστιάζοντας σε ένα κοντινό αντικείμενο, η κόρη φυσιολογικά συστέλλεται, οπότε διέρχονται μόνο οι κεντρικές φωτεινές ακτινοβολίες, αφού όμως διαπεράσουν πρώτα το ένθεμα. Οι φωτεινές ακτίνες του κοντινού αντικειμένου που διέρχονται από την κεντρική ζώνη του ενθέματος θα εστιάζονται πίσω από τον αμφιβληστροειδή και η θολή εικόνα που δημιουργούν απορρίπτεται από το οπτικό σύστημα. Οι φωτεινές ακτίνες του κοντινού αντικειμένου που διέρχονται από την περιφερική ζώνη του ενδοκερατοειδικού ενθέματος θα εστιάζονται στον αμφιβληστροειδή. Σαν αποτέλεσμα, μόνο η περιφερική ζώνη του ενθέματος παρέχει κοντινή διόρθωση και επηρεάζει τη μακρινή όραση, ενώ το κεντρικό τμήμα του ενδοκερατοειδικού φακού και η εκτός του ενθέματος ζώνη του κερατοειδούς δεν επηρεάζουν τη μακρινή όραση του ασθενούς.INTRODUCTION Presbyopia (aging of accommodation mechanism of the human eye) represents a common problem for people aged over 40-45 years. Many theories have been proposed during the past decades regarding explanation of the pathologic physiology of presbyopia development. The most popular theory of those, states that presbyopia is the result of a progressive reduction of Lens ability to accommodate, that worsens with age, due to either Lens hardening or degeneration of the ciliary body tissues. Regardless of the responsible cause, presbyopia reduces the ability of near vision affecting everyday life of individuals. American studies have reported that in 1998, over 113 millions of Americans were over 45 years old, underlining the effect of presbyopia condition. A wide variety of procedures have been investigated by ophthalmologists to correct the refractive error. Cornea laser surgery with multifocal patterns or monovision approaches were developed including LASIK, PresbyLASIK, photorefractive keratectomy (PRK), laser epithelial keratomileusis (LASEK), thin-flap femto-LASIK or sub-Bowman’s keratomileusis (SBK). Conductive keratoplasty (CK), Clear Lens Extraction or cataract surgery using multifocal, pseudo-accommodative intraocular Lenses (IOLs) or monovision monofocal IOLs are also some of the techniques that have been used for the treatment of presbyopia. Cornea laser surgery and CK are minimal invasive methods, but they provoke irreversible changes at corneal anatomy, whereas scleral surgery and Clear Lens Extraction are more invasive techniques. The necessity to develop a minimal invasive, reversible, and safe surgical technique with an easy learning curve for patients between 45 and 60 years, who could be considered too old for presbyopia corneal laser surgery and too young for Lens Extraction, led to the development of refractive intracorneal Lenses (inlays) (Flexivue™ Micro-Lens) placed underneath cornea inside a pocket in the corneal stroma. The inlays are refractive Lenses that have a central zone free of refractive power and a peripheral zone with a standard positive refractive power. The inlays are inserted inside a pocket in the corneal stroma of the non dominant eye, offering two different focal points, one for the far vision and a different for the near vision respectively. The pocket of the cornea is created using a femtosecond laser. The Flexivue™ Micro-Lens is a transparent, hydrophilic disc with 3 mm diameter and approximately 15 μm edge thickness. The central 1.6 mm diameter of the disc is plano and the peripheral zone has an add power. The base power available range from +1.5 D to +3.50 D in 0.25 D increments. At the center of the disc there is a hole of 0.15 mm diameter that permits the transfer of oxygen and nutrients of the cornea through the Lens. The Lens is implanted inside a pocket of the corneal stroma in the center of the visual axes of the non dominant eye. The Lens has a bifocal optical system which acts as a modified monovision (smart 10 monovision). During far vision the rays pass through the central zone of the inlay without refractive effect and will be sharply focused on the retina, whereas the rays which pass through the refractive peripheral zone will be not of focus in front of the retina. During near vision, the rays which pass through the central zone will be out of focus behind the retina and the rays which pass through the Lens peripheral refractive zone will be focused on the retina. As a result, only the peripheral zone of the Lens provides the near vision correction, and affects far vision, whereas the central zone of the Lens and the peripheral unaltered part of the cornea do not affect the far vision. CLINICAL HYPOTHESIS The working clinical hypothesis for this study is that implantation of the Flexivue™ Micro-Lens into a pocket created by femtosecond laser in the cornea, if correctly placed in the center of the cornea corresponding to the visual axes, will enable the study patients to obtain functional near vision without further correction while maintaining their distance. PURPOSE OF THE STUDY The purpose of this study is to evaluate the safety and efficacy of the Flexivue™ Micro- Lens for the treatment of presbyopia with enhanced medication regimen. STUDY POPULATION For the study, approximately 10 patients in each group will be enrolled at one location. To qualify for enrollment in this study, each candidate will be thoroughly evaluated to ensure that they meet all inclusion criteria and that they do not exhibit any of the exclusion criteria specified in the study protocol. METHODS This prospective, interventional clinical study comprised 47 emmetropic, presbyopes with a mean age of 51.55 years± 4.11 (range 45 to 60 years). The inlay was implanted, centred on the line of sight, inside a corneal pocket created in the non-dominant eye of the patients, using a femtosecond laser. Follow-up time was 12 months. Visual acuity, topography, wavefront aberrometry, contrast sensitivity, structural corneal alterations and questionnaires were evaluated. STUDY PARAMETERS Efficacy Measures: Uncorrected near visual acuity. Safety Measures: Best Corrected near visual acuity, Biomicroscopy Satisfaction Measures: Patient satisfaction questionnaire RESULTS Twelve months after surgery, uncorrected near visual acuity (UNVA) was 20/32 or better in 75% of the operated eyes, whereas mean uncorrected distance visual acuity (UDVA) of the operated eyes was statistically significantly reduced (p&λτ0.001) and mean 11 uncorrected distance visual acuity (UDVA) binocularly was not significantly altered (p=0.516).Seventeen patients lost one line of corrected distance visual acuity (CDVA) in the operated eye. Overall higher order aberrations were increased and contrast sensitivity was decreased in the operated eyes. No tissue alterations were found using corneal confocal microscopy. No intra or late-operative complications occurred. CONCLUSIONS Intracorneal refractive inlay for presbyopia FlexivueTM Micro-Lens using the femtosecond laser seems to represent an effective and safe method for the corneal compensation of presbyopia in emmetropic presbyopes aged between 45 and 60 years old, twelve months after the implantation
Universitat Autònoma De Barcelona. Departament De Cirurgia - One of the best experts on this subject based on the ideXlab platform.
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Lentes intraoculares para ojo fáquico de fijación iridiana para la corrección de defectos de la refracción
Bellaterra : Universitat Autònoma de Barcelona, 2010Co-Authors: Morral Palau Mercè, Güell Villanueva, Josep Lluís, Universitat Autònoma De Barcelona. Departament De CirurgiaAbstract:Descripció del recurs: 18 gener 2011El implante de lentes intraoculares (LIOs) para ojo fáquico ha experimentado una creciente popularidad en los últimos años, hasta el punto de convertirse en la técnica de elección para la corrección de defectos refractivos moderados-severos por la mayor parte de cirujanos refractivos. A diferencia de la cirugía láser sobre la córnea o de la cirugía del cristalino, la corrección de ametropías moderadas-severas mediante LIOs fáquicas consigue una mejor calidad óptica, a la vez que permite mantener la acomodación y afinar defectos refractivos residuales mediante cirugía corneal mínima. Además, se trata de un procedimiento relativamente reversible, ya que es posible extraer la lente en caso de no adaptación a la corrección o de presentarse algún efecto indeseado. Han existido en el mercado diversos modelos de LIOs fáquicas pero sólo dos de ellos han sido aprovados por la FDA ('Food and Drug Administration'). La primera LIO fáquica en aprovarse fue la lente de fijación iridiana Artisan® - Verisyse® como alternativa a la cirugía láser para disminuir o eliminar miopía de -5.0 a -20.0 dioptrías en adultos de edad igual o superior a 21 años, en septiembre del 2004. Los estudios multicéntricos europeo y de la FDA nos muestran datos de eficacia y seguridad a los 2 y 3 años de seguimiento tras la cirugía. Sin embargo, no existen datos a largo plazo, con la excepción del seguimiento de 10 años de Tahzib y cols. de lentes Artisan® para miopía. Sólo un mayor tiempo de seguimiento nos permitirá asegurar que la presencia de estas lentes dentro del ojo no sólo es efectiva, sino también segura. Nuestros datos tras 5 años de seguimiento de 399 ojos muestran que la LIO fáquica de fijación iridiana Artisan®/Verisyse® es un procedimiento efectivo y seguro para la corrección de defectos de la refracción moderados-severos, incluyendo miopía, hipermetropía y/o astigmatismo. La comparación de dos tipos diferentes de LIOs fáquicas de cámara anterior, la lente Acrysof (lente plegable de apoyo angular) y la lente Artisan®/Verisyse® (lente rígida de fijación iridiana), no mostró diferencias significativas en cuanto a eficacia y seguridad, excepto en el astigmatismo inducido por la cirugía en los tres primeros meses del postoperatorio. Ambos tipos de lentes mostraron un excelente perfil de eficacia y seguridad tras 5 años de seguimiento. Finalmente, realizamos un estudio dinámico durante la acomodación mediante tomografía de coherencia óptica de segmento anterior (Visante), mostrando la relación entre estas lentes con las estructuras intraoculares, que nos proporciona una mayor comprensión de las potenciales complicaciones a largo plazo.In recent years, phakic intraocular Lens (PIOL) implantation has gained increased popularity. Nowadays, most refractive surgeons consider it the procedure of choice to correct moderate-to-high ammetropias. Compared with corneal ablation techniques and Clear Lens Extraction, the implantation of PIOLs is believed to provide better optical quality, maintenance of accommodation and fine-tuning of the refractive result by minimal corneal refractive surgery. Moreover, it is a relatively reversible procedure, as the PIOL may be taken out in case complications occur. The first PIOL to gain FDA approval was the iris-claw Artisan®/Verisyse®, which was approved in September 2004 for the correction of myopia ranging -5 to -20 diopters in adults older than 21 years-old. European multicenter and FDA studies show efficacy and safety data at 2 and 3 years of follow-up. However, there is a lack of longer term follow-up data, with the exception of Tahzib's et al. studies 10 years after implantation. To stablish the efficacy and safety of any procedure, long-term follow-up data is essential. After 5 years, Artisan®/Verisyse® PIOL implantation has shown excellent efficacy and safety for the correction of moderate-to-high ammetropias, including myopia, hyperopia and/or astigmatism in a series of 399 eyes. We have compared two different types of anterior chamber PIOLs, the Acrysof (foldable, angle-supported PIOL) and the Artisan®/Verisyse® (rigid, iris-claw PIOL). No significant differences concerning efficacy and safety were found, except for surgical induced astigmatism the first 3 postoperative months. Both PIOLs showed excellent efficacy and safety profiles after 5 years. Finally, dynamic accommodation studies using anterior segment optical coherence tomography has provided unvaluable insights of the relation between iris-claw PIOLs and intraocular structures that may explain potential long-term complications
Morral Palau I Mercè - One of the best experts on this subject based on the ideXlab platform.
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Lentes intraoculares para ojo fáquico de fijación iridiana para la corrección de defectos de la refracción
'Universitat Autonoma de Barcelona', 2009Co-Authors: Morral Palau I MercèAbstract:El implante de lentes intraoculares (LIOs) para ojo fáquico ha experimentado una creciente popularidad en los últimos años, hasta el punto de convertirse en la técnica de elección para la corrección de defectos refractivos moderados-severos por la mayor parte de cirujanos refractivos. A diferencia de la cirugía láser sobre la córnea o de la cirugía del cristalino, la corrección de ametropías moderadas-severas mediante LIOs fáquicas consigue una mejor calidad óptica, a la vez que permite mantener la acomodación y afinar defectos refractivos residuales mediante cirugía corneal mínima. Además, se trata de un procedimiento relativamente reversible, ya que es posible extraer la lente en caso de no adaptación a la corrección o de presentarse algún efecto indeseado. Han existido en el mercado diversos modelos de LIOs fáquicas pero sólo dos de ellos han sido aprovados por la FDA ('Food and Drug Administration'). La primera LIO fáquica en aprovarse fue la lente de fijación iridiana Artisan® - Verisyse® como alternativa a la cirugía láser para disminuir o eliminar miopía de -5.0 a -20.0 dioptrías en adultos de edad igual o superior a 21 años, en septiembre del 2004. Los estudios multicéntricos europeo y de la FDA nos muestran datos de eficacia y seguridad a los 2 y 3 años de seguimiento tras la cirugía. Sin embargo, no existen datos a largo plazo, con la excepción del seguimiento de 10 años de Tahzib y cols. de lentes Artisan® para miopía. Sólo un mayor tiempo de seguimiento nos permitirá asegurar que la presencia de estas lentes dentro del ojo no sólo es efectiva, sino también segura.Nuestros datos tras 5 años de seguimiento de 399 ojos muestran que la LIO fáquica de fijación iridiana Artisan®/Verisyse® es un procedimiento efectivo y seguro para la corrección de defectos de la refracción moderados-severos, incluyendo miopía, hipermetropía y/o astigmatismo.La comparación de dos tipos diferentes de LIOs fáquicas de cámara anterior, la lente Acrysof (lente plegable de apoyo angular) y la lente Artisan®/Verisyse® (lente rígida de fijación iridiana), no mostró diferencias significativas en cuanto a eficacia y seguridad, excepto en el astigmatismo inducido por la cirugía en los tres primeros meses del postoperatorio. Ambos tipos de lentes mostraron un excelente perfil de eficacia y seguridad tras 5 años de seguimiento. Finalmente, realizamos un estudio dinámico durante la acomodación mediante tomografía de coherencia óptica de segmento anterior (Visante), mostrando la relación entre estas lentes con las estructuras intraoculares, que nos proporciona una mayor comprensión de las potenciales complicaciones a largo plazo.In recent years, phakic intraocular Lens (PIOL) implantation has gained increased popularity. Nowadays, most refractive surgeons consider it the procedure of choice to correct moderate-to-high ammetropias. Compared with corneal ablation techniques and Clear Lens Extraction, the implantation of PIOLs is believed to provide better optical quality, maintenance of accommodation and fine-tuning of the refractive result by minimal corneal refractive surgery. Moreover, it is a relatively reversible procedure, as the PIOL may be taken out in case complications occur. The first PIOL to gain FDA approval was the iris-claw Artisan®/Verisyse®, which was approved in September 2004 for the correction of myopia ranging -5 to -20 diopters in adults older than 21 years-old. European multicenter and FDA studies show efficacy and safety data at 2 and 3 years of follow-up. However, there is a lack of longer term follow-up data, with the exception of Tahzib's et al. studies 10 years after implantation. To stablish the efficacy and safety of any procedure, long-term follow-up data is essential. After 5 years, Artisan®/Verisyse® PIOL implantation has shown excellent efficacy and safety for the correction of moderate-to-high ammetropias, including myopia, hyperopia and/or astigmatism in a series of 399 eyes. We have compared two different types of anterior chamber PIOLs, the Acrysof (foldable, angle-supported PIOL) and the Artisan®/Verisyse® (rigid, iris-claw PIOL). No significant differences concerning efficacy and safety were found, except for surgical induced astigmatism the first 3 postoperative months. Both PIOLs showed excellent efficacy and safety profiles after 5 years. Finally, dynamic accommodation studies using anterior segment optical coherence tomography has provided unvaluable insights of the relation between iris-claw PIOLs and intraocular structures that may explain potential long-term complications
Morral Palau Mercè - One of the best experts on this subject based on the ideXlab platform.
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Lentes intraoculares para ojo fáquico de fijación iridiana para la corrección de defectos de la refracción
Bellaterra : Universitat Autònoma de Barcelona, 2010Co-Authors: Morral Palau Mercè, Güell Villanueva, Josep Lluís, Universitat Autònoma De Barcelona. Departament De CirurgiaAbstract:Descripció del recurs: 18 gener 2011El implante de lentes intraoculares (LIOs) para ojo fáquico ha experimentado una creciente popularidad en los últimos años, hasta el punto de convertirse en la técnica de elección para la corrección de defectos refractivos moderados-severos por la mayor parte de cirujanos refractivos. A diferencia de la cirugía láser sobre la córnea o de la cirugía del cristalino, la corrección de ametropías moderadas-severas mediante LIOs fáquicas consigue una mejor calidad óptica, a la vez que permite mantener la acomodación y afinar defectos refractivos residuales mediante cirugía corneal mínima. Además, se trata de un procedimiento relativamente reversible, ya que es posible extraer la lente en caso de no adaptación a la corrección o de presentarse algún efecto indeseado. Han existido en el mercado diversos modelos de LIOs fáquicas pero sólo dos de ellos han sido aprovados por la FDA ('Food and Drug Administration'). La primera LIO fáquica en aprovarse fue la lente de fijación iridiana Artisan® - Verisyse® como alternativa a la cirugía láser para disminuir o eliminar miopía de -5.0 a -20.0 dioptrías en adultos de edad igual o superior a 21 años, en septiembre del 2004. Los estudios multicéntricos europeo y de la FDA nos muestran datos de eficacia y seguridad a los 2 y 3 años de seguimiento tras la cirugía. Sin embargo, no existen datos a largo plazo, con la excepción del seguimiento de 10 años de Tahzib y cols. de lentes Artisan® para miopía. Sólo un mayor tiempo de seguimiento nos permitirá asegurar que la presencia de estas lentes dentro del ojo no sólo es efectiva, sino también segura. Nuestros datos tras 5 años de seguimiento de 399 ojos muestran que la LIO fáquica de fijación iridiana Artisan®/Verisyse® es un procedimiento efectivo y seguro para la corrección de defectos de la refracción moderados-severos, incluyendo miopía, hipermetropía y/o astigmatismo. La comparación de dos tipos diferentes de LIOs fáquicas de cámara anterior, la lente Acrysof (lente plegable de apoyo angular) y la lente Artisan®/Verisyse® (lente rígida de fijación iridiana), no mostró diferencias significativas en cuanto a eficacia y seguridad, excepto en el astigmatismo inducido por la cirugía en los tres primeros meses del postoperatorio. Ambos tipos de lentes mostraron un excelente perfil de eficacia y seguridad tras 5 años de seguimiento. Finalmente, realizamos un estudio dinámico durante la acomodación mediante tomografía de coherencia óptica de segmento anterior (Visante), mostrando la relación entre estas lentes con las estructuras intraoculares, que nos proporciona una mayor comprensión de las potenciales complicaciones a largo plazo.In recent years, phakic intraocular Lens (PIOL) implantation has gained increased popularity. Nowadays, most refractive surgeons consider it the procedure of choice to correct moderate-to-high ammetropias. Compared with corneal ablation techniques and Clear Lens Extraction, the implantation of PIOLs is believed to provide better optical quality, maintenance of accommodation and fine-tuning of the refractive result by minimal corneal refractive surgery. Moreover, it is a relatively reversible procedure, as the PIOL may be taken out in case complications occur. The first PIOL to gain FDA approval was the iris-claw Artisan®/Verisyse®, which was approved in September 2004 for the correction of myopia ranging -5 to -20 diopters in adults older than 21 years-old. European multicenter and FDA studies show efficacy and safety data at 2 and 3 years of follow-up. However, there is a lack of longer term follow-up data, with the exception of Tahzib's et al. studies 10 years after implantation. To stablish the efficacy and safety of any procedure, long-term follow-up data is essential. After 5 years, Artisan®/Verisyse® PIOL implantation has shown excellent efficacy and safety for the correction of moderate-to-high ammetropias, including myopia, hyperopia and/or astigmatism in a series of 399 eyes. We have compared two different types of anterior chamber PIOLs, the Acrysof (foldable, angle-supported PIOL) and the Artisan®/Verisyse® (rigid, iris-claw PIOL). No significant differences concerning efficacy and safety were found, except for surgical induced astigmatism the first 3 postoperative months. Both PIOLs showed excellent efficacy and safety profiles after 5 years. Finally, dynamic accommodation studies using anterior segment optical coherence tomography has provided unvaluable insights of the relation between iris-claw PIOLs and intraocular structures that may explain potential long-term complications
Joseph B Ciolino - One of the best experts on this subject based on the ideXlab platform.
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reliable intraocular pressure measurement using automated radio wave telemetry
Clinical Ophthalmology, 2014Co-Authors: Eleftherios I Paschalis, Fabiano Cade, Samir A Melki, Louis R Pasquale, Claes H Dohlman, Joseph B CiolinoAbstract:PURPOSE To present an autonomous intraocular pressure (IOP) measurement technique using a wireless implantable transducer (WIT) and a motion sensor. METHODS The WIT optical aid was implanted within the ciliary sulcus of a normotensive rabbit eye after extracapsular Clear Lens Extraction. An autonomous wireless data system (AWDS) comprising of a WIT and an external antenna aided by a motion sensor provided continuous IOP readings. The sensitivity of the technique was determined by the ability to detect IOP changes resulting from the administration of latanoprost 0.005% or dorzolamide 2%, while the reliability was determined by the agreement between baseline and vehicle (saline) IOP. RESULTS On average, 12 diurnal and 205 nocturnal IOP measurements were performed with latanoprost, and 26 diurnal and 205 nocturnal measurements with dorzolamide. No difference was found between mean baseline IOP (13.08±2.2 mmHg) and mean vehicle IOP (13.27±2.1 mmHg) (P=0.45), suggesting good measurement reliability. Both antiglaucoma medications caused significant IOP reduction compared to baseline; latanoprost reduced mean IOP by 10% (1.3±3.54 mmHg; P<0.001), and dorzolamide by 5% (0.62±2.22 mmHg; P<0.001). Use of latanoprost resulted in an overall twofold higher IOP reduction compared to dorzolamide (P<0.001). Repeatability was ±1.8 mmHg, assessed by the variability of consecutive IOP measurements performed in a short period of time (≤1 minute), during which the IOP is not expected to change. CONCLUSION IOP measurements in conscious rabbits obtained without the need for human interactions using the AWDS are feasible and provide reproducible results.