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.

Bilateral spontaneous suprachoroidal hemorrhage in a patient taking a low-molecular-weight-heparin.

We present the case of an 81-year-old woman who developed a bilateral spontaneous suprachoroidal hemorrhage while under treatment with sodium enoxaparin. Temporal suspension of anticoagulant therapy led to an improvement of the choroidal hemorrhage. After three months follow-up, there was a complete reabsorption of the choroidal detachments, but there was a persistent vitreous hemorrhage in the right eye, which had been more severely affected. Pars plana vitrectomy with air tamponade was successfully performed in the right eye. Vision improved to 20/50 in the right eye and 20/20 in the left eye. Suprachoroidal hemorrhage is a rare condition with a poor visual prognosis. Reports on the development of suprachoroidal hemorrhage in patients with no predisposing ocular conditions are scarce, and in none were both eyes affected. The case reported herein is, to the best of our knowledge, the first case of bilateral, simultaneous suprachoroidal hemorrhage without predisposing ocular factors due to treatment with anticoagulants, with a favourable visual outcome.

Macular involvement in congenital aniridia.

This review updates the knowledge about the morphological assessment of the foveal hypoplasia in congenital aniridia and resumes the reported genotype-phenotype correlations known to date. Congenital aniridia is a pan ocular disease. Although iris absence is considered the hallmark of this entity, foveal hypoplasia is present in 94.7%-84% of patients. A foveal morphology assessed by optical coherence tomography in which external retina structures can be identified, with presence of the lengthening of photoreceptors outer segment and a greater external retinal thickness, is associated with a better visual outcome, regardless a foveal pit is identified or not. This analysis can be performed once the external retina has completed its differentiation, by 6 years old. PAX6 mutations that introduce premature termination codon, C terminal extension or PAX6 involving deletions have been related to lesser foveal differentiation. Better foveal differentiation has been associated to non-coding PAX6 mutations.

Hemorragia supracoroidea espontánea bilateral en un paciente en tratamiento con heparina de bajo peso molecular / Bilateral spontaneous suprachoroidal hemorrhage in a patient taking a low-molecular-weight heparin

Presentamos el caso de una paciente de 81 años en tratamiento con enoxaparina sódica, que desarrolló una hemorragia supracoroidea espontánea bilateral. Tras suspender el tratamiento anticoagulante se produjo una mejoría clínica, que se mantuvo incluso tras reiniciar la anticoagulación. Tras 3 meses de seguimiento, la hemorragia coroidea se resolvió completamente en ambos ojos, pero se decidió realizar una vitrectomía pars plana en el ojo derecho de la paciente, el más afectado inicialmente, debido a un hemovítreo persistente. La agudeza visual alcanzada fue de 20/50 en el ojo derecho y 20/20 en el ojo izquierdo. La hemorragia supracoroidea es una entidad poco frecuente, asociada habitualmente a un mal pronóstico visual. Se han descrito pocos casos en la literatura de hemorragia supracoroidea en pacientes sin factores de riesgo oculares, ninguno de ellos bilateral. Este podría ser el primer caso descrito en la literatura de hemorragia supracoroidea bilateral simultánea sin factores oculares predisponentes relacionado con anticoagulantes, resuelto con un buen resultado visual (AU)

We present the case of an 81-year-old woman who developed a bilateral spontaneous suprachoroidal hemorrhage while under treatment with sodium enoxaparin. Temporal suspension of anticoagulant therapy led to an improvement of the choroidal hemorrhage. After three months follow-up, there was a complete reabsorption of the choroidal detachments, but there was a persistent vitreous hemorrhage in the right eye, which had been more severely affected. Pars plana vitrectomy with air tamponade was successfully performed in the right eye. Vision improved to 20/50 in the right eye and 20/20 in the left eye. Suprachoroidal hemorrhage is a rare condition with a poor visual prognosis. Reports on the development of suprachoroidal hemorrhage in patients with no predisposing ocular conditions are scarce, and in none were both eyes affected. The case reported herein is, to the best of our knowledge, the first case of bilateral, simultaneous suprachoroidal hemorrhage without predisposing ocular factors due to treatment with anticoagulants, with a favourable visual outcome (AU)

Macular involvement in congenital aniridia. / Alteraciones maculares en aniridia congénita.

This review updates the knowledge about the morphological assessment of the foveal hypoplasia in Congenital Aniridia and resumes the reported genotype-phenotype correlations known to date. Congenital Aniridia is a pan ocular disease. Although iris absence is considered the hallmark of this entity, foveal hypoplasia is present in 94.7-84% of patients. A foveal morphology assessed by optical coherence tomography in which external retina structures can be identified, with presence of the lengthening of photoreceptors outer segment and a greater external retinal thickness, is associated with a better visual outcome, regardless a foveal pit is identified or not. This analysis can be performed once the external retina has completed its differentiation, by 6 years old. PAX6 mutations that introduce premature termination codon, C terminal extension or PAX6 involving deletions have been related to lesser foveal differentiation. Better foveal differentiation has been associated to non-coding PAX6 mutations.

Bilateral spontaneous suprachoroidal hemorrhage in a patient taking a low-molecular-weight heparin. / Hemorragia supracoroidea espontánea bilateral en un paciente en tratamiento con heparina de bajo peso molecular.

We present the case of an 81-year-old woman who developed a bilateral spontaneous suprachoroidal hemorrhage while under treatment with sodium enoxaparin. Temporal suspension of anticoagulant therapy led to an improvement of the choroidal hemorrhage. After three months follow-up, there was a complete reabsorption of the choroidal detachments, but there was a persistent vitreous hemorrhage in the right eye, which had been more severely affected. Pars plana vitrectomy with air tamponade was successfully performed in the right eye. Vision improved to 20/50 in the right eye and 20/20 in the left eye. Suprachoroidal hemorrhage is a rare condition with a poor visual prognosis. Reports on the development of suprachoroidal hemorrhage in patients with no predisposing ocular conditions are scarce, and in none were both eyes affected. The case reported herein is, to the best of our knowledge, the first case of bilateral, simultaneous suprachoroidal hemorrhage without predisposing ocular factors due to treatment with anticoagulants, with a favourable visual outcome.

Desprendimiento neurosensorial macular recurrente en fístula carótido-cavernosa / Recurrent neurosensory macular detachment in carotid-cavernous fistula

CASO CLÍNICO: Varón de 46 años, acudió a Urgencias por disminución de agudeza visual y exoftalmos en ojo derecho. Aquejaba cefalea, diplopía de 4 meses de evolución e historia de desprendimiento neurosensorial (DNS) resuelto espontáneamente un mes antes. Presentaba tortuosidad de vasos conjuntivales y epiesclerales y nuevo DNS macular derecho. La sospecha de fístula carótido-cavernosa quedó confirmada mediante angiotomografía computarizada (angio-TC). Durante su ingreso la fístula se cerró espontáneamente. Al mes, el DNS había desaparecido. DISCUSIÓN: La fístula carótido-cavernosa debe incluirse en el diagnóstico diferencial de los DNS maculares. El DNS puede desaparecer espontáneamente al cerrarse la fístula

CASE REPORT: A 46 year-old man was seen in the emergency department complaining of vision loss and exophthalmos in his right eye. He also complained of headache, diplopia of 4 months onset, and neurosensory detachment that resolved spontaneously the month before. The study revealed tortuous conjunctival and episcleral vessels and neurosensory macular detachment in his right eye. A carotid-cavernous fistula was confirmed by computed tomography angiography. The fistula closed spontaneously during the hospitalization. One month later, the neurosensory detachment disappeared again. DISCUSSION: Carotid-cavernous fistula should be included in the differential diagnosis of neurosensory macular detachments. These neurosensory detachments can resolve spontaneously 11 the fistula is closed

[Recurrent neurosensory macular detachment in carotid-cavernous fistula]. / Desprendimiento neurosensorial macular recurrente en fístula carótido-cavernosa.

CASE REPORT: A 46 year-old man was seen in the emergency department complaining of vision loss and exophthalmos in his right eye. He also complained of headache, diplopia of 4 months onset, and neurosensory detachment that resolved spontaneously the month before. The study revealed tortuous conjunctival and episcleral vessels and neurosensory macular detachment in his right eye. A carotid-cavernous fistula was confirmed by computed tomography angiography. The fistula closed spontaneously during the hospitalization. One month later, the neurosensory detachment disappeared again. DISCUSSION: Carotid-cavernous fistula should be included in the differential diagnosis of neurosensory macular detachments. These neurosensory detachments can resolve spontaneously 11 the fistula is closed.

Efecto de la capsulotomía posterior con láser neodymium: YAG. Valoración de seguridad en el grosor foveal, la presión intraocular y el recuento de células endoteliales en pacientes pseudofáquicos con opacidad de cápsula posterior / Effect of posterior neodymium: YAG capsulotomy. Safety evaluation of macular foveal thickness, intraocular pressure and endothelial cell loss in pseudophakic patients with posterior capsule opacification

Objetivos: Determinar el efecto de la capsulotomía posterior en el grosor macular, presión intraocular (PIO) y pérdida de células endoteliales en pacientes pseudofáquicos que presentaban opacidad de la cápsula posterior, utilizando el ojo adelfo de cada paciente como control. Métodos: Se realizó un estudio prospectivo observacional en 31 pacientes pseudofáquicos con opacidad de la cápsula posterior en un ojo, utilizando el ojo adelfo como control durante un periodo de 3 meses. Se excluyó a los pacientes que presentaban otras enfermedades oculares o cirugías intraoculares aparte de la facoexéresis. A todos los pacientes se les realizó una capsulotomía posterior con láser Nd: YAG. El examen ocular, que se realizó previamente a la capsulotomía y en revisiones a la semana, al mes y a los 3 meses, incluía: agudeza visual mejor corregida (AVMC), PIO, tomografía de coherencia óptica macular (OCT) y recuento endotelial. Resultados: Se utilizaron ecuaciones de estimación generalizadas para valorar el efecto de la capsulotomía ajustado en función de situación basal y tiempo de seguimiento. No se encontró asociación significativa entre la capsulotomía y la PIO (p = 0,597), el grosor macular (p = 0,085) o el recuento endotelial (densitometría (p = 0,422), tamaño celular medio (p = 0,299), coeficiente de variación (p = 0,495), porcentaje de células hexagonales (0,093) y paquimetría (p = 0,423). Un incremento significativo de la AVMC se observó en la revisión a los 3 meses (p < 0,001). Conclusiones: Este estudio indica que, tras la capsulotomía posterior, la AVMC mejora significativamente, sin observarse cambios significativos en PIO, grosor macular o recuento endotelial. La capsulotomía con Nd:YAG es un procedimiento seguro en pacientes que no presenten enfermedades oculares asociadas (AU)

Objective: To determine the effect of posterior capsulotomy on macular thickness, intraocular pressure and endothelial cell loss in pseudophakic patients with posterior capsule opacification using the other eye of every patient as a control. Methods: An observational prospective study was conducted on 31 pseudophakic patients with posterior capsular opacification in one eye, using the other eye as a control. Patients did not suffer any other ocular pathology. All patients were treated by posterior capsular opacification with Nd: YAG capsulotomy, and followed up for a three-month period. The ocular examination included, best corrected visual acuity (BCVA), intraocular pressure (IOP),macular optical coherence tomography (OCT), and endothelial cell assessment (including densitometry, cell size and coefficient of variation, hexagonal cell percentage and pachymetry),which were determined in both eyes before treatment, and one week, one month and 3 months after capsulotomy. Results: Generalized estimating equations (GEE) were used to assess the capsulotomy effect adjusted by corresponding baseline measurements and time. No association was found between capsulotomy and IOP (P =0.597), macular thickness (P =0.085) or ECA (densitometry (P =0.422), average size of cells (P =0.299), variation coefficient (P =0.495), hexagonal cell percent (P =0.093) and corneal pachymetry (P =0.423). A significant increase of 0.15 Snellen units in BCVA was found during the 3-month follow-up period (P <0.001).Conclusion: This study shows that after Nd: YAG capsulotomy, BCVA improves significantly without any IOP, OCT or ECA changes during the three-month follow-up. Nd: YAG capsulotomy is a safe procedure in pseudophakic patients without any other ocular pathology (AU)

[Effect of posterior neodymium:YAG capsulotomy. Safety evaluation of macular foveal thickness, intraocular pressure and endothelial cell loss in pseudophakic patients with posterior capsule opacification]. / Efecto de la capsulotomía posterior con láser neodymium:YAG. Valoración de seguridad en el grosor foveal, la presión intraocular y el recuento de células endoteliales en pacientes pseudofáquicos con opacidad de cápsula posterior.

OBJECTIVE: To determine the effect of posterior capsulotomy on macular thickness, intraocular pressure and endothelial cell loss in pseudophakic patients with posterior capsule opacification using the other eye of every patient as a control. METHODS: An observational prospective study was conducted on 31 pseudophakic patients with posterior capsular opacification in one eye, using the other eye as a control. Patients did not suffer any other ocular pathology. All patients were treated by posterior capsular opacification with Nd:YAG capsulotomy, and followed up for a three-month period. The ocular examination included, best corrected visual acuity (BCVA), intraocular pressure (IOP), macular optical coherence tomography (OCT), and endothelial cell assessment (including densitometry, cell size and coefficient of variation, hexagonal cell percentage and pachymetry), which were determined in both eyes before treatment, and one week, one month and 3 months after capsulotomy. RESULTS: Generalized estimating equations (GEE) were used to assess the capsulotomy effect adjusted by corresponding baseline measurements and time. No association was found between capsulotomy and IOP (P=.597), macular thickness (P=.085) or ECA (densitometry (P=.422), average size of cells (P=.299), variation coefficient (P=.495), hexagonal cell percent (P=.093) and corneal pachymetry (P=.423). A significant increase of 0.15 Snellen units in BCVA was found during the 3-month follow-up period (P<.001). CONCLUSION: This study shows that after Nd:YAG capsulotomy, BCVA improves significantly without any IOP, OCT or ECA changes during the three-month follow-up. Nd:YAG capsulotomy is a safe procedure in pseudophakic patients without any other ocular pathology.

Design and characterization of biofunctional magnetic porous silicon flakes.

Magnetic porous silicon flakes (MPSF) were obtained from mesoporous silicon layers formed by multi-step anodization and subsequent composite formation with Fe oxide nanoparticles by thermal annealing. The magnetic nanoparticles adhered to the surface and penetrated inside the pores. Their structure evolved as a result of the annealing treatments derived from X-ray diffraction and X-ray absorption analyses. Moreover, by tailoring the magnetic load, the dynamic and hydrodynamic properties of the particles were controlled, as observed by the pressure displayed against a sensor probe. Preliminary functionality experiments were performed using an eye model, seeking potential use of MPSF as reinforcement for restored detached retina. It was observed that optimal flake immobilization is obtained when the MPSF reach values of magnetic saturation >10(-4)Am(2)g(-1). Furthermore, the MPSF were demonstrated to be preliminarily biocompatible in vitro. Moreover, New Zealand rabbit in vivo models demonstrated their short-term histocompatibility and their magnetic functionality as retina pressure actuators.