Reporte de incidentes serios en productos sanitarios usados en cirugía intraocular. Proponiendo ideas / Reporting serious incidents in medical devices used in intraocular surgery: Proposing ideas

La entrada en vigor del reglamento sobre productos sanitarios obliga a los clínicos a identificar y reportar a las autoridades sanitarias los posibles incidentes serios derivados de su utilización. Dadas las dudas que pueden suscitarse sobre qué puede o no considerarse incidente serio, un grupo de trabajo, creado por miembros de la Sociedad Española de Retina y Vitreo (SERV) y el clúster de oftalmología y ciencias de la visión (Cluster4Eye), han elaborado un documento que pretende orientar a los oftalmólogos sobre algunos de los incidentes que, en la experiencia del equipo de trabajo, no son habituales o pueden causar un serio daño a la función del paciente. (AU)

The entry into force of the regulation on medical devices obliges clinicians to identify and report to the Health Authorities possible serious incidents arising from their use. In view of the doubts that may arise as to whether or not it may be considered a serious incident, a working group, set up by members of the Spanish Society of Retina and Vitreous (SERV) and the cluster of ophthalmology and vision sciences (Cluster4Eye) have prepared a document that aims to guide ophthalmologists about some of the incidents that, in the experience of the work team, are not common or can cause serious damage to the patient's function. (AU)

Reporting serious incidents in medical devices used in intraocular surgery: Proposing ideas.

The entry into force of the regulation on medical devices obliges clinicians to identify and report to the Health Authorities possible serious incidents arising from their use. In view of the doubts that may arise as to whether or not it may be considered a serious incident, a working group, set up by members of the Spanish Society of Retina and Vitreo and the cluster of ophthalmology and vision sciences (Cluster4Eye) have prepared a document that aims to guide ophthalmologists about some of the incidents that, in the experience of the work team, are not common or can cause serious damage to the patient's function.

Management of Wet Age-Related Macular Degeneration in Spain: Challenges for Treat and Extend Implementation in Routine Clinical Practice.

PURPOSE: To ascertain wet AMD (wAMD) management patterns in Spain. METHODS: A two-round Delphi study conducted through a questionnaire-based survey designed from literature review and validated by an independent Steering Committee. RESULTS: Forty-nine retina specialists experienced in wAMD participated by answering the two-round study questionnaire. Retina specialists are the main responsible for wAMD diagnosis and monitoring, including visits and associated procedures, with a median time per visit of 15 minutes. Standard treatment strategies are based on anti-VEGF administration, including standard loading dose administration followed by maintenance with aflibercept or ranibizumab (81% of patients). Although treat and extend (T&E) dosing strategy is considered as optimal for wAMD management (78% of the panelists), the main routine healthcare limitations (i.e., visits overload, reduced staff, short visit time, coordination issues, lack of facilities) conduct to self-defined "flexible" strategies, based on T&E and pro-re-nata (PRN) protocols. CONCLUSION: Proactive treatment patterns (T&E) are the preferred ones by the retina specialists in Spain. However, their proper implementation is difficult due to healthcare resource limitations, as well as organisation and logistic issues. The use of anti-VEGF agents with longer duration of action could facilitate the use of strict T&E approaches according to routine clinical practices.

Hemangioma coroideo y terapia fotodinámica. Respuesta anatómica y funcional de los pacientes con hemangioma coroideo tratados con terapia fotodinámica / Choroidal haemangioma and photodynamic therapy. Anatomical and functional response of patients with choroidal hemangioma treated with photodynamic therapy

Objetivo: Estudiar la eficacia y las limitaciones de la terapia fotodinámica (TFD) como tratamiento de primera elección en pacientes con hemangioma coroideo circunscrito sintomático. Métodos: Se realizó un estudio retrospectivo de 16 pacientes (13 varones y 3 mujeres, con una media de edad de 54,88 años) con hemangioma coroideo circunscrito visitados en nuestro centro y tratados con TFD en los últimos 7 años. Resultados: Todos los pacientes presentaban hemangioma coroideo circunscrito, que ocasionaba sintomatología secundaria a la presencia de edema microquístico intrarretiniano o desprendimiento neurosensorial. La agudeza visual (AV) media inicial del grupo era de 0,23 y la AV media posterior a la realización de TFD fue de 0,38 (todas las AV fueron medidas en escala decimal). Cabe destacar que los pacientes necesitaron una media de 1,69 sesiones de TFD. Tres de los pacientes necesitaron un tratamiento de rescate con termoterapia transpupilar, inyección intravítrea de antifactor de crecimiento endotelial vascular (ranibizumab, aflibercept) o implante intravítreo de dexametasona (Ozurdex®). La indicación de cambio de tratamiento fue la persistencia de edema microquístico intrarretiniano y/o desprendimiento neurosensorial (o su resolución incompleta) tras 3 sesiones de TFD. Como resultados generales, destacamos que un 62,5% de los pacientes evolucionó hacia la resolución anatómica y funcional (incremento de AV o estabilidad). Conclusiones: La TFD es un procedimiento dirigido y rápido, con buena respuesta anatómica y funcional, que ocasiona un mínimo daño a los vasos adyacentes a la lesión (AU)

Objective: To study the effectiveness and limitations of photodynamic therapy (PDT) as treatment of choice in patients with symptomatic circumscribed choroidal haemangioma. Methods: A retrospective study was conducted on 16 patients (13 men and 3 women, with mean age of 54.88 years) with circumscribed choroidal haemangioma, who attended our centre and were treated with PDT in the last 7 years. Results: All patients had circumscribed choroidal haemangioma, which caused a decrease in visual acuity (VA) secondary to the presence of intraretinal microcystic oedema or neurosensory detachment. The mean initial VA was 0.23, and the final mean VA after performing PDT was 0.38 (all the VA were measured in decimal scale). It should be noted that patients needed a mean of 1.69 PDT sessions. Three of the patients needed rescue treatment with trans-pupillary thermotherapy, intravitreal injection of anti-vascular endothelial growth factor (ranibizumab, aflibercept) or a dexamethasone intravitreal implant (Ozurdex®). The indication for a change of treatment was the persistence of intraretinal microcystic oedema and/or neurosensory detachment (or incomplete resolution) after 3 PDT sessions. As overall results, 62.5% of patients evolved into anatomical and functional (increase in AV or stability) resolution. Conclusions: PDT is a straight forward and fast procedure, with a good anatomical and functional response, causing minimal damage to adjacent vessels (AU)

Choroidal haemangioma and photodynamic therapy. Anatomical and functional response of patients with choroidal hemangioma treated with photodynamic therapy. / Hemangioma coroideo y terapia fotodinámica. Respuesta anatómica y funcional de los pacientes con hemangioma coroideo tratados con terapia fotodinámica.

OBJECTIVE: To study the effectiveness and limitations of photodynamic therapy (PDT) as treatment of choice in patients with symptomatic circumscribed choroidal haemangioma. METHODS: A retrospective study was conducted on 16 patients (13 men and 3 women, with mean age of 54.88 years) with circumscribed choroidal haemangioma, who attended our centre and were treated with PDT in the last 7 years. RESULTS: All patients had circumscribed choroidal haemangioma, which caused a decrease in visual acuity (VA) secondary to the presence of intraretinal microcystic oedema or neurosensory detachment. The mean initial VA was 0.23, and the final mean VA after performing PDT was 0.38 (all the VA were measured in decimal scale). It should be noted that patients needed a mean of 1.69 PDT sessions. Three of the patients needed rescue treatment with trans-pupillary thermotherapy, intravitreal injection of anti-vascular endothelial growth factor (ranibizumab, aflibercept) or a dexamethasone intravitreal implant (Ozurdex®). The indication for a change of treatment was the persistence of intraretinal microcystic oedema and/or neurosensory detachment (or incomplete resolution) after 3 PDT sessions. As overall results, 62.5% of patients evolved into anatomical and functional (increase in AV or stability) resolution. CONCLUSIONS: PDT is a straight forward and fast procedure, with a good anatomical and functional response, causing minimal damage to adjacent vessels.

Tratamiento no quirúrgico de la tracción vitreomacular y del agujero macular / Non-surgical treatment of vitreomacular traction and macular hole

No disponible

Nuevas pautas de tratamiento y seguimiento en pacientes con degeneración macular asociada a la edad exudativa / New treatment protocols and follow-up in patients with exudative age-related macular degeneration

Las inyecciones intravítreas de ranibizumab (Lucentis®) son el tratamiento de elección de los pacientes con degeneración macular exudativa. En los últimos años se han ensayado diversas pautas de tratamiento y seguimiento con el fin de optimizar los resultados de eficacia y seguridad. En la práctica clínica habitual, fundamentalmente se utilizan los protocolos PRN (pro re nata) y treat and extend o variantes tipo el régimen FUSION. Los protocolos PRN se basan en el seguimiento regular del paciente y en su retratamiento ante la evidencia de reactivación de la lesión, básicamente determinada por pérdida de agudeza visual y fluido macular persistente o recurrente en la tomografía de coherencia óptica. Los protocolos treat and extend o FUSION se basan en el retratamiento precoz de la lesión antes de que se produzca su reactivación, buscando evitar las pérdidas no reversibles de visión que pueden producirse en las recurrencias de la enfermedad. No se ha podido encontrar un protocolo de tratamiento y seguimiento ideal alternativo al régimen mensual que pueda aplicarse y reproducirse en todos los casos, por lo que el tratamiento con ranibizumab intravítreo debe individualizarse en cada paciente(AU)

Intravitreal ranibizumab (Lucentis®) injections are the treatment of choice in patients with exudative macular degeneration. In the last few years, several treatment and follow-up strategies have been evaluated with the aim of optimizing the safety and efficacy of this drug. In routine clinical practice, the Pro Re Nat a (PRN) and treat-and-extend protocols or variants of the FUSION regimen have been used. PRN protocols are based on regular patient follow-up and on retreatment when there is evidence of reactivation of the lesion, basically determined by loss of visual acuity and persistent or recurrent macular fluid on optical coherence tomography. Treat-and-extend or FUSION protocols are based on early retreatment of the lesion before reactivation occurs with the aim of avoiding the irreversible visual loss that can occur in disease recurrences. There is no ideal treatment and follow-up protocol that could be used as an alternative to the monthly regimen and be applied and reproduced in all patients. Consequently, intravitreal ranibizumab therapy should be individualized in each patient(AU)

[New treatment protocols and follow-up in patients with exudative age-related macular degeneration]. / Nuevas pautas de tratamiento y seguimiento en pacientes con degeneración macular asociada a la edad exudativa.

Intravitreal ranibizumab (Lucentis®) injections are the treatment of choice in patients with exudative macular degeneration. In the last few years, several treatment and follow-up strategies have been evaluated with the aim of optimizing the safety and efficacy of this drug. In routine clinical practice, the Pro Re Nata (PRN) and treat-and-extend protocols or variants of the FUSION regimen have been used. PRN protocols are based on regular patient follow-up and on retreatment when there is evidence of reactivation of the lesion, basically determined by loss of visual acuity and persistent or recurrent macular fluid on optical coherence tomography. Treat-and-extend or FUSION protocols are based on early retreatment of the lesion before reactivation occurs with the aim of avoiding the irreversible visual loss that can occur in disease recurrences. There is no ideal treatment and follow-up protocol that could be used as an alternative to the monthly regimen and be applied and reproduced in all patients. Consequently, intravitreal ranibizumab therapy should be individualized in each patient.

[Guidelines of clinical practice of the SERV: treatment of exudative age-related macular degeneration (AMD)]. / Guías de práctica clínica de la SERV: tratamiento de la degeneración macular asociada a la edad (DMAE) exudativa.

OBJECTIVE: Age related macular degeneration (ARMD) in its neovascular form is a serious disease which produces legal blindness in many patients with poor prognosis if left untreated. We intend to establish a clinical guide with the different therapeutic options that exist nowadays, which may help the ophthalmologists in their clinical practice. METHODS: A group of medical retina experts selected by SERV have evaluated the results of different published studies with the drugs currently available, obtaining an evidence-based consensus. Some recommendations have been established for diagnosis, treatment and monitoring of patients with neovascular ARMD. RESULTS: The intravitreal injection of ranibizumab at a dosage of 0.5 mg produces significant improvement of visual acuity in subfoveal lesions, according to data obtained from studies with the highest level of evidence. It should be considered as a first choice drug. The use of bevacizumab, a drug with not approved indication for intraocular use, nor for the treatment of neovascular ARMD can reach a result which is closer to the ones obtained with ranibizumab than to those obtained with photodynamic therapy (PDT) and pegaptanib. The use of intravitreal pegaptanib sodium in intravitreal injection at a dosage of 0.3 mg as a treatment for subfoveal lesions can obtain similar results to the TFD, but with a wider range of injuries. CONCLUSION: The results of the evidence-based studies are a good guide for the treatment of this disease.

Guías de práctica clínica de la SERV: tratamiento de la degeneración macular asociada a la edad (DMAE) exudativa / Guidelines of clinical practice of the SERV: treatment of exudative age-related macular degeneration (AMD)

Objetivo: La Degeneración Macular Asociada a laEdad (DMAE) en su forma húmeda supone unagrave enfermedad que condiciona ceguera legal enmuchos pacientes y con mal pronóstico si no es tratada.Pretendemos establecer una guía de actuaciónclínica con las diferentes opciones terapeúticas queexisten en el momento actual, que puedan ayudar aloftalmólogo en su práctica clínica.Métodos: Un grupo de expertos en retina médicaseleccionados por la SERV han evaluado los resultadosde los diferentes estudios publicados con losfármacos actualmente disponibles, llegando a un consenso basado en la evidencia. Se han establecidounas recomendaciones para el diagnóstico, tratamientoy seguimiento de los enfermos con DMAEhúmeda.Resultados: La inyección intravítrea de ranibizumaba la dosis de 0,5 mg permite obtener mejoríassignificativas de la agudeza visual en lesiones subfoveales,según los datos obtenidos de estudios conmáximo nivel de evidencia. Debe ser consideradocomo el fármaco de primera elección. El empleo debevacizumab, fármaco sin indicación aprobada parauso intraocular, ni para el tratamiento de la DMAEhúmeda, puede aportar un beneficio más próximo alos resultados obtenidos con el ranibizumab que alos obtenidos con la terapia fotodinámica (TFD) yel pegaptanib. El uso de pegaptanib sódico eninyección intravítrea a la dosis de 0,3 mg como tratamientode lesiones subfoveales permite obtenerresultados parecidos a la TFD, pero en un abanicomás amplio de lesionesConclusiones: Los resultados de los estudios basadosen la evidencia constituyen una buena guía deactuación en el tratamiento de esta enfermedad(AU)

Objective: Age related macular degeneration(ARMD) in its neovascular form is a serious diseasewhich produces legal blindness in many patientswith poor prognosis if left untreated. We intend toestablish a clinical guide with the different therapeuticoptions that exist nowadays, which may helpthe ophthalmologists in their clinical practice.Methods: A group of medical retina experts selectedby SERV have evaluated the results of differentpublished studies with the drugs currently available,obtaining an evidence-based consensus. Somerecommendations have been established for diagnosis, treatment and monitoring of patients with neovascularARMD.Results: The intravitreal injection of ranibizumabat a dosage of 0.5 mg produces significant improvementof visual acuity in subfoveal lesions, accordingto data obtained from studies with the highestlevel of evidence. It should be considered as a firstchoice drug. The use of bevacizumab, a drug withnot approved indication for intraocular use, nor forthe treatment of neovascular ARMD can reach aresult which is closer to the ones obtained with ranibizumabthan to those obtained with photodynamictherapy (PDT) and pegaptanib. The use of intravitrealpegaptanib sodium in intravitreal injection at adosage of 0.3 mg as a treatment for subfoveallesions can obtain similar results to the TFD, butwith a wider range of injuries.Conclusion: The results of the evidence-based studiesare a good guide for the treatment of this disease(AU)

[Multifocal electroretinogram and age-related macular degeneration]. / Electrorretinograma multifocal y degeneración macular asociada a la edad.

PURPOSE: To assess the value of multifocal electroretinogram (mfERG) in clinical evaluation of the response of patients with choroidal neovascularization (CNV), secondary to age-related macular degeneration, to photodynamic therapy (PDT). METHODS: We designed a prospective non-comparative case series and enrolled 23 eyes of 22 patients with predominantly classic CNV. The initial evaluation included clinical examination with measurement of visual acuity (Colenbrander), biomicroscopic evaluation (BMC), retinography, fluorescein angiography (FA), Humphrey 24-2 visual field examination and mfERG. All patients were treated with PDT. Clinical follow-up was performed two and six months after treatment with visual acuity evaluation, BMC, visual field assessment and mfERG. FA was repeated after an interval of between four and six months in all patients. RESULTS: Visual acuity remained stable or improved in all patients included in the study. Visual field examination gave erratic and unreliable results because of patients' unstable fixation. N1 and P1 wave peak amplitudes in the central rings did not change significantly after treatment but they improved in rings 3 (p=0.000), 4 and 5 (p=0.008). CONCLUSIONS: Multifocal ERG is a useful tool for the clinical follow-up of CNV. It offers interesting non-subjective data of retinal sensitivity of patients with macular diseases treated with PDT. In addition we obtained a central retinal sensitivity map where we were able to evaluate the extent and depth of retinal damage.

Terapia antiangiogénica / Antiangiogenic therapy

No disponible

No disponible

Electrorretinograma multifocal y degeneración macular asociada a la edad / Multifocal electroretinogram and age-related macular degeneration

Objetivo: Determinar la utilidad del electrorretinograma multifocal (mfERG) en la evaluación clínica de la respuesta al tratamiento con terapia fotodinámica (TFD) en pacientes con neovascularización coroidea (NVC) secundaria a degeneración macular asociada a la edad (DMAE).Métodos: Se ha realizado un estudio prospectivo en 23 ojos de 22 pacientes con NVC predominantemente clásica. Al inicio se realizó una medición de la agudeza visual mediante optotipos de Colenbrander, exploración biomicroscópica (BMC), retinografía, angiografía fluoresceínica (AGF), campimetría de Humphrey 24-2 y mfERG. Todos los pacientes fueron tratados mediante TFD. Se ha repetido la exploración de la agudeza visual, BMC, campimetría y mfERG a los dos y a los seis meses del tratamiento y se ha realizado una AGF tras un intervalo entre los cuatro y seis meses del inicio del estudio.Resultados: La agudeza visual permanece estable o mejora en todos los pacientes incluidos en el estudio. El estudio campimétrico nos ofrece resultados erráticos y poco fiables debido a la mala fijación que presentan estos pacientes. La densidad de respuesta de las ondas N1 y P1 del mfERG en los anillos centrales no muestra variaciones significativas después del tratamiento, sin embargo mejora en los anillos 3 (p=0,000), 4 y 5 (p=0,008).Conclusiones: El mfERG es una prueba de utilidad en el seguimiento de la NVC puesto que nos permite medir objetivamente la sensibilidad retiniana en pacientes con maculopatías tratadas con terapia fotodinámica. Por otra parte obtenemos un mapa de sensibilidades de la retina central en el que podemos valorar la extensión y la profundidad de la lesión

Purpose: To assess the value of multifocal electroretinogram (mfERG) in clinical evaluation of the response of patients with choroidal neovascularization (CNV), secondary to age-related macular degeneration, to photodynamic therapy (PDT) Methods: We designed a prospective non-comparative case series and enrolled 23 eyes of 22 patients with predominantly classic CNV. The initial evaluation included clinical examination with measurement of visual acuity (Colenbrander), biomicroscopic evaluation (BMC), retinography, fluorescein angiography (FA), Humphrey 24-2 visual field examination and mfERG. All patients were treated with PDT. Clinical follow-up was performed two and six months after treatment with visual acuity evaluation, BMC, visual field assessment and mfERG. FA was repeated after an interval of between four and six months in all patients. Results: Visual acuity remained stable or improved in all patients included in the study. Visual field examination gave erratic and unreliable results because of patients’ unstable fixation. N1 and P1 wave peak amplitudes in the central rings did not change significantly after treatment but they improved in rings 3 (p=0.000), 4 and 5 (p=0.008). Conclusions: Multifocal ERG is a useful tool for the clinical follow-up of CNV. It offers interesting non-subjective data of retinal sensitivity of patients with macular diseases treated with PDT. In addition we obtained a central retinal sensitivity map where we were able to evaluate the extent and depth of retinal damage