[Translated article] Syringes for intraocular administration: A systematic review.

OBJECTIVE: The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous of some patients. This situation derives from the lack of approved syringes for intraocular use in the Spanish market. The aim of this work is to review the use of syringes for intraocular administration, as well as to search for alternatives that meet the legal requirements for these unmet needs. METHOD: A systematic review was performed following the PRISMA 2020 guidelines by searching PubMed with the descriptors: (silicone) AND (syringes) AND ((intraocular) OR (intravitreal)) and filtering all existing publications from January 2006 to December 2023, including all those articles dealing with silicone oil release in intravitreal injections and analysing the possible consequences. RESULTS: Sixty-eight results were found, 23 of which were excluded because they did not deal with the subject under study, leaving a total of 45 articles for the systematic review. These were classified according to the conclusions obtained in 4 groups: the adverse reactions produced by silicone; the administration technique; the physicochemical aspects of silicone release; and the characteristics of the medical device. After reviewing the current manufacturers and technical data sheets of commercialised syringes, the existing syringes for this use have been collected, finding 2 that will probably be commercialised in Spain at the beginning of 2024: Zero Residual™ 0.2 ml SiO-free and VitreJect® Ophthalmic. CONCLUSIONS: From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.

Syringes for intraocular administration: Systematic review. / Jeringas para administración intraocular: revisión sistemática.

OBJECTIVE: The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous of some patients. This situation derives from the lack of approved syringes for intraocular use in the Spanish market. The aim of this work is to review the use of syringes for intraocular administration, as well as to search for alternatives that meet the legal requirements for these unmet needs. METHOD: A systematic review was performed following the PRISMA 2020 Guidelines by searching PubMed with the descriptors: "silicone" AND "syringes" AND ("intraocular" OR "intravitreal") and filtering all existing publications from January 2006 to December 2023, including all those articles dealing with silicone oil release in intravitreal injections and analysing the possible consequences. RESULTS: Sixty-eight results were found, 23 of which were excluded because they did not deal with the subject under study, leaving a total of 45 articles for the systematic review. These were classified according to the conclusions obtained in 4 groups: the adverse reactions produced by silicone, the administration technique, the physicochemical aspects of silicone release, and the characteristics of the medical device. After reviewing the current manufacturers and technical data sheets of commercialized syringes, the existing syringes for this use have been collected, finding two that will probably be commercialized in Spain at the beginning of 2024: Zero Residual™ 0.2 ml SiO-free and VitreJect® Ophthalmic. CONCLUSIONS: From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.

Transoperative intravitreal dexamethasone implantation in patients with proliferative vitreoretinopathy.

OBJECTIVE: To compare the anatomical results in patients with rhegmatogenous retinal detachment, at least grade B of proliferative vitreoretinopathy, and with a trans-surgical dexamethasone implant vs the control group. We also assessed the diminution of proliferative vitreoretinopathy and the final visual acuity (VA). METHOD: The patients were evaluated clinically and with optical coherence tomography for 10 months. Logistic regression analyses were performed to evaluate the effect of the dexamethasone implant on retinal detachment. Correlational analyses were explored depending on the variables' distribution, and an independent samples t-test was used to compare the VA in both groups. RESULTS: The study included 38 eyes of patients with proliferative vitreoretinopathy: 18 with the implant and 20 for the control group. The evaluation of the main objective showed significant differences (p < 0.05) in the anatomical success between the two groups (61.1% vs. 20%, treatment vs. control); odds ratio of 6.29; 95% confidence interval: 1.5- 26.8; p = 0.013; Nagelkerke's R2 = 0.225. The t-test showed a significant difference in the final VA of the patients (t = 2.047; df = 36; p = 0.048; Cohen's d = 0.66). CONCLUSIONS: Retinal redetachment was less frequent, and better VA was observed, in patients with the dexamethasone implant in comparison with the control group.

OBJETIVO: Comparar los resultados anatómicos en pacientes con desprendimiento de retina regmatógeno, vitreorretinopatía proliferativa a partir de grado B y aplicación de implante de dexametasona transquirúrgico frente a un grupo control. También se valoraron la disminución de la vitreorretinopatía proliferativa y la agudeza visual (AV) final. MÉTODO: Los pacientes se evaluaron clínicamente y con tomografía de coherencia óptica por 10 meses. Se realizaron análisis de regresión logística para evaluar el efecto del implante en el redesprendimiento de retina. Se exploraron análisis correlacionales dependiendo de la distribución de variables y se aplicó la prueba t de muestras independientes para comparar la AV en ambos grupos. RESULTADOS: Se incluyeron 38 ojos de pacientes con vitreorretinopatía proliferativa: 18 con el implante y 20 del grupo control. La evaluación del objetivo principal mostró diferencias significativas (p < 0.05) en el éxito anatómico entre ambos grupos (61.1% en los ojos con tratamiento frente a 20% en el grupo control); razón de momios de 6.29; intervalo de confianza del 95%: 1.5- 26.8; p = 0.013; R2 de Nagelkerke = 0.225. La prueba t mostró una diferencia significativa entre la AV final de los pacientes (t = 2.047; gl = 36; p = 0.048; d de Cohen = 0.66). CONCLUSIONES: Se observó menor redesprendimiento, así como mejor AV, en los pacientes con el implante de dexametasona en comparación con el grupo control.

Diagnóstico diferencial de las reacciones inflamatorias tras uso de medicación intravítrea en degeneración macular asociada a la edad: estéril vs. infeccioso / Differential diagnosis of endophthalmitis after intravitreal drug injection for age related macular degeneration: Sterile vs. infectious

El interés por las complicaciones inflamatorias tras la inyección intravítrea de fármacos antiangiogénicos ha aumentado tras la comercialización de brolucizumab y el desarrollo de nuevas moléculas como el abicipar pegol. Dichos fármacos se asocian a una tasa de complicaciones inflamatorias mayor a los antiangiogénicos clásicos. En este contexto resulta clave el diferenciar procesos infecciosos y estériles para realizar un tratamiento efectivo y precoz. El solapamiento del cuadro clínico entre procesos infecciosos y estériles, la baja tasa de positividad en los cultivos y la heterogeneidad en la terminología son barreras para el correcto diagnóstico y reporte de las complicaciones inflamatorias tras la inyección de medicación antiangiogénica intravítrea. Los cuadros estériles comienzan de forma precoz tras la inyección, dentro de las primeras 48 h, o alrededor de 20 días después en los casos de vasculitis asociada a brolucizumab. Los procesos infecciosos comienzan como promedio en el tercer día tras la inyección, y hasta una semana después de la misma. La disminución grave de la agudeza visual, el dolor severo, la hiperemia severa, el hipopion y un mayor grado de inflamación intraocular deben orientar hacia procesos infecciosos. En los casos en que exista duda sobre la etiología de la inflamación, debe procederse a un control muy estrecho del paciente o al tratamiento antimicrobiano empírico junto con la toma de muestra para evitar complicaciones derivadas de una endoftalmitis infecciosa. Por el contrario, los fenómenos estériles deben ser tratados con observación en los casos más leves o corticoterapia adaptada a la gravedad de inflamación en los casos más graves (AU)

The recent release of brolucizumab and the development of new antiangiogenic molecules as abicipar pegol has increased the interest towards inflammatory complications after intravitreal drug injection. Those drugs are associated to a higher rate of inflammatory adverse events compared to classic drugs. In this context it is essential to differentiate between sterile and infectious cases for a fast and effective treatment. The clinical similarities between infectious and sterile cases, the high rate of culture negative patients and the heterogeneity in the terminology used are obstacles for a correct diagnosis and report of these complications. Sterile cases appear early after the injection, before 48h; or 20 days after in brolucizumab-related vasculitis cases. Infectious cases show up around the third day after injection and up to a week after it. A severe visual impairment, severe pain, severe hyperemia, hypopyon and a more severe intraocular inflammatory process are signs of a likely infectious origin. If the cause of the inflammation is uncertain we must follow up the patient closely or “tap and inject” antimicrobial agents in order to prevent the eventual complications of an infectious endophthalmitis. On the other hand, sterile endophthalmitis might be observed in mild cases or treated with steroids according to the severity of the inflammation (AU)

Differential diagnosis of endophthalmitis after intravitreal drug injection for age related macular degeneration: sterile vs. infectious.

The recent release of brolucizumab and the development of new antiangiogenic molecules as abicipar pegol has increased the interest towards inflammatory complications after intravitreal drug injection. Those drugs are associated to a higher rate of inflammatory adverse events compared to classic drugs. In this context it is essential to differentiate between sterile and infectious cases for a fast and effective treatment. The clinical similarities between infectious and sterile cases, the high rate of culture negative patients and the heterogeneity in the terminology used are obstacles for a correct diagnosis and report of these complications. Sterile cases appear early after the injection, before 48 h; or 20 days after in brolucizumab-related vasculitis cases. Infectious cases show up around the third day after injection and up to a week after it. A severe visual impairment, severe pain, severe hyperemia, hypopyon and a more severe intraocular inflammatory process are signs of a likely infectious origin. If the cause of the inflammation is uncertain we must follow up the patient closely or "tap and inject" antimicrobial agents in order to prevent the eventual complications of an infectious endophthalmitis. On the other hand, sterile endophthalmitis might be observed in mild cases or treated with steroids according to the severity of the inflammation.

Brevibacterium casei endophthalmitis after intravitreal dexamethasone implant.

CLINICAL CASE: 49-year-old man with diabetic macular edema refractory to antiangiogenics, it is decided to perform therapy with intravitreal dexamethasone implant (Ozurdex; Allergan, California, United States of America). Seven days after treatment, he showed acute endophthalmitis suggestive signs. Despite the intravitreal injection of antibiotics, the patient got worse. Vitreous sampling was repeated for Gram and cultures, and vitrectomy was performed via pars plana. The culture suggested the development of Brevibacterium species. Through an additional test, the presence of Brevibacterium casei was confirmed. Despite the treatment adjusted by antibiogram, retinal ischemia and macular atrophy was evident. DISCUSSION: Brevibacterium casei is a Gram-positive bacterium, barely pathogenic, that mainly affects immunodepressed patients. Only two cases of endophthalmitis are described, one endogenous and the other one secondary to vegetal trauma. This is the first case of endophthalmitis, secondary to an ophthalmological procedure.

Endoftalmitis aguda por Brevibacterium casei tras implante intravítreo de dexametasona / Brevibacterium casei endophthalmitis after intravitreal dexamethasone implant

Caso clínico Hombre de 49años, con edema macular diabético refractario a antiangiogénicos, en el que se realizó terapia intravítrea con implante de dexametasona (Ozurdex; Allergan, California, Estados Unidos). Tras 7días presentó signos sugerentes de endoftalmitis aguda. Pese a la inyección intravítrea de antibióticos, el paciente empeoró. Se repitió la toma de muestras en vítreo para Gram y cultivos, y se realizó vitrectomía vía pars plana. El cultivo sugirió el desarrollo de Brevibacterium species. Mediante una prueba adicional, se confirmó la presencia de Brevibacterium casei. Pese al tratamiento ajustado por antibiograma, se evidenció isquemia retiniana y atrofia macular. Discusión Brevibacterium casei es una bacteria grampositiva, escasamente patógena, que afecta principalmente a inmunodeprimidos. Se han descrito solo dos casos de endoftalmitis, una endógena y otra secundaria a trauma vegetal. Este es el primer caso de endoftalmitis por Brevibacterium casei secundaria a procedimiento oftalmológico (AU)

Clinical case A 49-year-old man with diabetic macular edema refractory to antiangiogenics was treated with intravitreal dexamethasone implant (Ozurdex; Allergan, California, USA). Seven days after treatment, he showed acute endophthalmitis suggestive signs. Despite the intravitreal injection of antibiotics, the patient got worse. Vitreous sampling was repeated for Gram and cultures, and vitrectomy was performed via pars plana. The culture suggested the development of Brevibacterium species. Through an additional test, the presence of Brevibacterium casei was confirmed. Despite the treatment adjusted by antibiogram, retinal ischemia and macular atrophy was evident. Discusion Brevibacterium casei is a Gram-positive bacterium, barely pathogenic, that mainly affects immunodepressed patients. Only two cases of endophthalmitis are described, one endogenous and the other one secondary to vegetal trauma. This is the first case of Brevibacterium casei endophthalmitis, secondary to an ophthalmological procedure (AU)

Brevibacterium casei endophthalmitis after intravitreal dexamethasone implant. / Endoftalmitis aguda por Brevibacterium casei tras implante intravítreo de dexametasona.

CLINICAL CASE: A 49-year-old man with diabetic macular edema refractory to antiangiogenics was treated with intravitreal dexamethasone implant (Ozurdex; Allergan, California, USA). Seven days after treatment, he showed acute endophthalmitis suggestive signs. Despite the intravitreal injection of antibiotics, the patient got worse. Vitreous sampling was repeated for Gram and cultures, and vitrectomy was performed via pars plana. The culture suggested the development of Brevibacterium species. Through an additional test, the presence of Brevibacterium casei was confirmed. Despite the treatment adjusted by antibiogram, retinal ischemia and macular atrophy was evident. DISCUSION: Brevibacterium casei is a Gram-positive bacterium, barely pathogenic, that mainly affects immunodepressed patients. Only two cases of endophthalmitis are described, one endogenous and the other one secondary to vegetal trauma. This is the first case of Brevibacterium casei endophthalmitis, secondary to an ophthalmological procedure.

Effectiveness of treat-and-extend versus pro re nata regimens in the treatment of Neovascular Age Macular Degeneration: A Real World Comparison. / Efectividad de los regímenes tratar y extender vs. pro re nata para el tratamiento de degeneración macular neovascular vinculada a la edad: una comparación en un entorno real.

PURPOSE: Evaluate and compare the visual and morphological results of Pro re nata (PRN) and treat-and-extend (T&E) treatment regimens at 3 years in real world clinical practice. METHODS: Retrospective study of patients with neovascular age macular degeneration (AMD) treated with anti-VEGF with 3 years of continuous follow-up and no previous anti-VEGF treatment. Best corrected visual acuity (BCVA), central foveal thickness (CFT) and number of intravitreal injections outcomes were tested for statistical differences between the two groups at baseline and during follow-up. RESULTS: A total of 240 eyes were included in the study, 170 in the PRN group and 70 in the T&E group. At 12 months, mean BCVA (ETDRS letters) gain from baseline was at its highest point in the T&E group (+6.38±13.32; p=0.25). In the PRN group, BCVA peaked at 3 months and slowly decreased until end of follow-up. With both regimens, from baseline, CFT continued to decrease until the second year (PRN -138.81 [-846.7 to +162.77] and T&E -81 [-604 to +100] µm, p=0.06). After that, T&E group maintained this tendency, reaching the lowest CFT value at 36 months, whereas PRN group showed an increased in CFT values (PRN -104 [-807.7 to +297] µm and T&E -103 [-575 to +244], µm p=0.63). Patients treated with T&E regimen received a significantly higher number of injections (PRN 16.3±7.6 vs T&E 23.9 ±9.4, p<0.01). CONCLUSION: Our results demonstrated a trend towards for T&E to achieve higher marks in BCVA, peaking at 12 months, and lower CFT thickness at the end of three years. Despite the higher number of injections performed in the T&E group the mean BCVA reverts to baseline values at 3 years.

Terapia anti-angiogénica con ranibizumab en el tratamiento de retinopatía de la prematuridad / Intravitreal ranibizumab injections in patients with retinopathy of prematurity (ROP)

RESUMEN Objetivo: describir los desenlaces luego de la aplicación de terapia antiangiogénica intravítrea con Ranibizumab en pacientes con retinopatía de la prematuridad (ROP), tratados inicialmente con termoterapia transpupilar láser sin regresión de la enfermedad. Métodos: cohorte histórica en Clínica Universitaria Bolivariana (CUB) durante 2008-2015. Evaluación de pacientes prematuros con retinopatía agresiva posterior y enfermedad umbral que recibieron termoterapia transpupilar láser como tratamiento inicial. Debido a que continuaba el proceso de neovascularización, se indicó terapia antiangiogénica intravítrea con ranibizumb. El desenlace primario fue la resolución de la neovascularización (NV) y la ausencia de recurrencia. Los desenlaces secundarios fueron agudeza visual y complicaciones oculares y sistémicas. Resultados: ocho ojos de 4 pacientes fueron incluidos. Se encontró resolución de la neovascularización en 6 de los 8 ojos, densidad de incidencia 48 x 100 personas año, IC 95 % = 17,6 - 100 con una mediana de seguimiento de 23.5 meses, rango 13-90 meses. No se encontraron complicaciones oculares ni sistémicas. Conclusión: esta pequeña cohorte sugiere que la inyección intravitrea de ranibizumab para ROP, en casos que inicialmente se trataron con termoterapia transpupilar con láser y no se resolvió la retinopatía, ayudaría como complemento para una evolución favorable.

SUMMARY Purpose: To describe ocular outcomes after intravitreal ranibizumab injections in patients with retinopathy of prematurity (ROP), who had transpupillary laser thermotherapy without regression of the disease. Methods: Historical cohort in Clínica Universitaria Bolivariana (CUB) during 2008-2015. Evaluation of patients with aggressive posterior ROP, threshold disease, who received intravitreal ranibizumab secondary to treatment with transpupillary thermotherapy. The primary outcome was treatment success defined as the resolution of neovascularization (NV) and no recurrence. The secondary endpoints were visual acuity and ocular and systemic complications. Results: Eight eyes of four patients were included in the study. Six eyes had resolution of retinopathy, Incidence density 48 x 100 person years, 95 % CI = 17.6 - 100 with a median follow-up of 23.5 months, range 13-90 months. No ocular or systemic complications associated with the procedure was found. Conclusion: This cohort suggests that intravitreal injection of ranibizumab for ROP in refractory laser photocoagulation cases, results in apparent ocular preservation a long-term the outcome.

Desgarros del epitelio pigmentario de la retina: factores de riesgo, mecanismo y control terapéutico.

Los desgarros del epitelio pigmentario de la retina (EPR) se asocian en la mayoría de los casos con los desprendimientos vascularizados del EPR debido a una degeneración macular asociada a la edad (DMAE), y normalmente implican una pérdida adversa de la agudeza visual. Estudios recientes indican que ha habido un aumento en la incidencia de desgarros del EPR desde la introducción de fármacos anti-factor de crecimiento del endotelio vascular (anti-VEGF) así como una asociación temporal entre el desgarro y la inyección intravítrea. Dado que el número de pacientes con DMAE y el número de inyecciones anti-VEGF va en aumento, tanto la dificultad de prevenir desgarros del EPR como el tratamiento tras la formación de los desgarros han adquirido una mayor relevancia. De forma paralela, la evolución de la imagenología de la retina ha contribuido de manera significativa a comprender mejor el desarrollo de los desgarros del EPR en los últimos años. Esta revisión resume los conocimientos que se poseen actualmente sobre el desarrollo, los factores pronósticos y las estrategias terapéuticas de los desgarros del EPR antes y después de que estos se formen.

Endoftalmitis posvitrectomía por Pseudomona aeruginosa / Post-vitrectomy endophthalmitis caused by Pseudomona aeruginosa

Se describe el caso de un paciente varón de 22 años, miope, sometido a vitrectomía pars plana 23 G en ojo único (valioso), por desprendimiento de retina regmatógeno. A las 24 horas presentó pérdida de visión, dolor, signos inflamatorios en globo y anejos oculares. Acudió al Servicio de Emergencias, donde se decidió su ingreso hospitalario para la toma de muestra y la aplicación de inyección intravítrea de vancomicina (1 mg/0,1 mL) y ceftazidima (2 mg/0,1 mL), con lo que mostró mejoría clínica. El estudio microbiológico reportó Pseudomona aeruginosa sensible a la ceftazidima y a la ciprofloxacina. La mejor visualización fundoscópica al quinto día posintravítrea permitió observar depósitos blanquecinos en la interfaz aceite de silicona-retina, y se decidió la extracción de aceite por incisiones mixtas 23 g y 20 g (infusión, endoiluminación y extracción respectivamente), lavado de cámara anterior, cámara vítrea, reposición de aceite de silicón y segunda dosis de ceftazidima, con evolución posoperatoria favorable. Se dio el alta una semana después, con la retina aplicada y una mejor visión corregida de 0,1(AU)

This is the report about a male 22 years-old myopic patient who underwent a pars plana 23 G vitrectomy in one eye (valuable) due to regmatogen retinal detachment. Twenty four hours after the surgery, he presented with vision loss, pain, eye bulb inflammation and ocular adnexa. He went to the emergency service where it was decided to admitted him to the hospital for sample taking and application of intravitreal injection of vancomycin (1 mg/0,1 mL) and ceftazidime (2 mg/0,1 mL) which brought about clinical improvement. The microbiological test reported the presence of ceftazidime and ciprofloxacine-susceptible Pseudomona aeruginosa. The fundus oculi performed five days after vitrectomy allowed observing whitish deports in the silicon oil/retina interface, so it was decided to remove the oil by making mixed incisions of 23 and 20 g (infusion, endoilumination and extraction, respectively), washing the anterior chamber, the vitreal chamber, returning the silicon oil and a second dosage of ceftazidime, all of which caused favorable postoperative progress. One week later, he was discharged from the hospital with replaced retina and better corrected vision of 0.1(AU)

Endoftalmitis posvitrectomía por Pseudomona aeruginosa / Post-vitrectomy endophthalmitis caused by Pseudomona aeruginosa

Se describe el caso de un paciente varón de 22 años, miope, sometido a vitrectomía pars plana 23 G en ojo único (valioso), por desprendimiento de retina regmatógeno. A las 24 horas presentó pérdida de visión, dolor, signos inflamatorios en globo y anejos oculares. Acudió al Servicio de Emergencias, donde se decidió su ingreso hospitalario para la toma de muestra y la aplicación de inyección intravítrea de vancomicina (1 mg/0,1 mL) y ceftazidima (2 mg/0,1 mL), con lo que mostró mejoría clínica. El estudio microbiológico reportó Pseudomona aeruginosa sensible a la ceftazidima y a la ciprofloxacina. La mejor visualización fundoscópica al quinto día posintravítrea permitió observar depósitos blanquecinos en la interfaz aceite de silicona-retina, y se decidió la extracción de aceite por incisiones mixtas 23 g y 20 g (infusión, endoiluminación y extracción respectivamente), lavado de cámara anterior, cámara vítrea, reposición de aceite de silicón y segunda dosis de ceftazidima, con evolución posoperatoria favorable. Se dio el alta una semana después, con la retina aplicada y una mejor visión corregida de 0,1(AU)

This is the report about a male 22 years-old myopic patient who underwent a pars plana 23 G vitrectomy in one eye (valuable) due to regmatogen retinal detachment. Twenty four hours after the surgery, he presented with vision loss, pain, eye bulb inflammation and ocular adnexa. He went to the emergency service where it was decided to admitted him to the hospital for sample taking and application of intravitreal injection of vancomycin (1 mg/0,1 mL) and ceftazidime (2 mg/0,1 mL) which brought about clinical improvement. The microbiological test reported the presence of ceftazidime and ciprofloxacine-susceptible Pseudomona aeruginosa. The fundus oculi performed five days after vitrectomy allowed observing whitish deports in the silicon oil/retina interface, so it was decided to remove the oil by making mixed incisions of 23 and 20 g (infusion, endoilumination and extraction, respectively), washing the anterior chamber, the vitreal chamber, returning the silicon oil and a second dosage of ceftazidime, all of which caused favorable postoperative progress. One week later, he was discharged from the hospital with replaced retina and better corrected vision of 0.1(AU)

Endophthalmitis after intravitreal injections. Incidence, management and prognosis. / Endoftalmitis tras inyecciones intravítreas. Incidencia, manejo y pronóstico.

OBJECTIVE: To assess the rate of endophthalmitis after intravitreal injection (IVI) in a «clean room¼ of a single health centre, following the guidelines of the Spanish Vitreo-Retinal Society (SERV). An analysis was performed on the culture specimens, response to treatment, and final outcomes (guidelines). MATERIAL AND METHODS: A retrospective, observational study was conducted on a consecutive case series of patients diagnosed with infectious endophthalmitis after IVI in a single health centre between 2010 and 2015. Intravitreal and systemic treatment was given following the SERV guidelines. The patients were followed up the case was resolved. RESULTS: There were 5 cases of endophthalmitis out of 9467 IVI (incidence 0.053%). Positive cultures were obtained in aqueous and/or vitreous fluid in all cases, with Staphylococcus epidermidis being involved in 4 out of 5 cases. In 2 cases, final visual acuity was non-light perception due to intractable retinal detachments after resolution of the infectious process. CONCLUSIONS: IVI performed in a «clean room¼ have a low incidence of endophthalmitis. The most common infectious agent was Staphylococcus species. In 2 cases the functional prognosis was poor.

[New perspectives in the approach to diabetic macular edema. Aflibercept therapy]. / Nuevas perspectivas en el abordaje del edema macular diabético. Tratamiento con aflibercept.

The VISTA and VIVID trials were conducted to compare the safety and efficacy of two intravitreal injection (IVI) regimens of aflibercept versus macular laser photocoagulation for the treatment of diabetic macular edema (DME). These double-masked, phase III clinical trials randomized (461/402) patients with DME to receive either 2mg aflibercept IVI every 4 weeks (2q4) or 2mg aflibercept IVI every 8 weeks (2q8) after 5 initial monthly doses vs macular laser photocoagularion. The primary efficacy endpoint was the mean change in best corrected visual acuity (BCVA) from baseline to week 52. Secondary efficacy endpoints were the change in central retinal thickness (CRT), the proportion of patients who gained ≥10 amd ≥15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, and the change in the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in near and distance vision. The mean BCVA gains in the 2q4 and 2q8 groups versus the laser group were 12.5 and 10.7 versus 0.2 letters (p<0.0001) in VISTA, and 10.5 and 10.7 versus 1.2 letters (p<0.0001) in VIVID. The proportions of patients gaining ≥ 15 letters and the proportion of patients with an improvement of > 2 levels in the severity of diabetic retinopathy was significant in the treatment groups versus the laser group. Mean reductions in CRT in the 2q4 and 2q8 groups vs the laser group were 185.9 and 183.1 versus 73.3 µm (p<0.0001) in VISTA, and 195.0 and 192.4 versus 66.2 µm (p<0.0001) in VIVID. The incidences of ocular and nonocular adverse events were similar in all groups. In conclusion, IIV aflibercept demonstrated statistically significant superiority in improvement in BCVA and reduction in DME over laser, with similar efficacy in the 2q4 and 2q8 groups in VISTA and VIVID.

Intravitreal injections: what do patients prefer? Analysis of patient's satisfaction and preferences about where to perform intravitreal injections.

OBJECTIVE: To analyse satisfaction and patient preferences on the location where they receive an intravitreal injection. METHOD: A survey was conducted with the intention of analysing these patients who attended the macula clinic and have been intervened using an intravitreal injection at least once in the day hospital or in the theatre setting, comparing both locations. RESULTS: The majority of the interviewed patients preferred the day hospital (50.0 versus 37.5%), mostly because of the comfort and the quick service. In patients with severe age-related macular degeneration (AMD) the option is reversed. The overall satisfaction level was positive in both cases (with 87.5% of patients satisfied or very satisfied in the day hospital and 91.1% in the theatre setting). Through the analysis of different aspects of clinical care the assessment was the same or superior for 75.0% of these patients, except in the waiting time. There were no cases of endophthalmitis. CONCLUSION: In general, patients prefer the clinical intervention in the consulting room than in the theatre setting because of the quicker service. There are several characteristics that can influence this choice and should be taken into account.

Ranibizumab intravítreo para el tratamiento de la membrana neovascular peripapilar secundaria a papiledema por hipertensión endocraneana idiopática: informe de un caso / Intravitreal ranibizumab for peripapillary neovascular membrane associated to papiledema due to idiopathic intracranial hypertension: a case report

Las membranas neovasculares peripapilares son una complicación rara del papiledema crónico, y son aún más infrecuentes en el contexto del papiledema por hipertensión endocraneana idiopática (HEI). Dada su escasez, es difícil plantear estudios para definir la alternativa terapéutica más adecuada. Se presenta el caso de una mujer con papiledema por HEI quien desarrolló membrana neovascular peripapilar, y cuyo tratamiento con ranibizumab intravítreo fue exitoso.

Peripapillary neovascular membrane is a rare complication of chronic papiledema. When the latter is due to idiopathic intracranial hypertension, neovascularization is even rarer. Because of this low occurrence, it is difficult to design studies to define the most appropriate treatment. We report the case of a woman who developed papiledema by idiopathic intracranial hypertension with peripapillary neovascular membrane, and who was successfully treated with intravitreal ranibizumab.

[Intravitreal bevacizumab for choroidal neovascularization associated with Best's disease]. / Bevacizumab intravítreo en neovascularización coroidea asociada a enfermedad de Best.

CASE REPORT: A 27-year old woman presented with loss of vision in the right eye (20/200). Ophthalmoscopic examination showed intrarretinal hemorrhage in the macular region with neurosensory detachment in the right eye, and viteliform deposit on the left eye. Fluorescein angiography and the electrooculogram confirmed the diagnosis of choroidal neovascularization associated with Best's disease. Four weeks after a single bevacizumab intravitreal injection, visual acuity was restored (20/25) and remained stable after a 12 month follow-up. DISCUSSION: Intravitreal bevacizumab appears to be an effective treatment for choroidal neovascularization associated to Best's disease.

Flora bacteriana en agujas de inyección de Ranibizumab en la Fundación Oftalmológica Nacional / Bacterial flora in Ranibizumab injection needles at Fundación Oftalmológica Nacional

Objetivo: describir la prevalencia de contaminación bacteriana de agujas utilizadas en inyecciones intravítreas en pacientes tratados con Ranibizumab, analizar la flora normal conjuntival, identificar el germen más común en cultivos de agujas utilizadas y establecer la eficacia de profilaxis antibiótica preoperatoria en la reducción de la flora normal conjuntival presente en el procedimiento. Métodos: estudio observacional descriptivo tipo serie de casos. Se incluyen pacientes de la Fundación Oftalmológica Nacional sometidos a inyección intravítrea de Ranibizumab desde Abril 6 a Septiembre 28 del 2010. Edades entre 44 - 91 años. Se tomó frotis conjuntival del fondo de saco inferior para cultivo de flora normal al momento de la inyección y de la aguja utilizada y no utilizada. Se siembran muestran en tres medios de cultivo a 37ºC/ 5 días. Resultados: se realizaron 150 cultivos, 50 ojos de 50 pacientes. 44 pacientes (88%) fueron consistentes y se incluyeron en el análisis. 6 (12%) fueron no consistentes. Staphylococcus aureus, Staphylococcus epidermidis, Bacillus subtilis, Difteroides y Staphylococcus haemolyticus. El Staphylococcus aureus fue la bacteria causal más frecuente contaminante de la aguja utilizada (10%), Difteroides (4%) y Bacillus subtilis (4%). Difteroides, Bacillus subtilis y Staphylococcus aureus fueron los contaminantes de las agujas no utilizadas. El Staphylococcus haemolyticus, aureus, epidermidis y Difteroides fueron cultivados en la flora normal conjuntival de pacientes con cultivo de aguja negativo. El 61.4% de los cultivos no presentaron crecimiento bacteriano. Conclusión: el Staphylococcus aureus fue la bacteria causal más frecuente de contaminación de las agujas utilizadas siendo el Bacillus subtilis el principal contaminante de agujas no utilizadas. El uso de profilaxis antibiótica previa al procedimiento reduce significativamente el inóculo bacteriano. Se requieren futuros estudios con ampliación de la muestra para controlar posibles fallas técnicas.

Purpose: to evaluate the prevalence of bacterial contamination in needles used for intravitreal injections of Ranibizumab, analyze conjunctival flora, identify the most common microorganism present in used needles and evaluate the efficacy of antibiotic prophylaxis in reducing conjunctival flora at the time of the procedure. Methods: a case series study. Patients of the Fundación Oftalmológica Nacional, who underwent intravitreal injections of Ranibizumab between April 6 and September 28, 2010. Ages 44 to 91 years. The used needle, an unused control needle and a conjunctival scraping from the inferior fornix were inoculated in tryptone soy broth at 37°C for 5 days. Results: 150 cultures were obtained from 50 patients.44 patients had consistent results (negative control needle) and were included in the analysis. Staphylococcus aureus, Staphylococcus epidermidis, Bacillus subtilis, Difteroides, y Staphylococcus haemolyticus were identified. Staphylococcus aureus was the most frequent contaminant of the used needles (10%), followed by Difteroides (4%) and Bacillus subtilis (4%). Difteroides, Bacillus subtilis and Staphylococcus aureus were found in unused needles. Staphylococcus haemolyticus, aureus, epidermidis and Difteroides were found in the conjunctival samples. 61.4% had negative cultures. Conclusion: Staphylococcus aureus was the most frequent contaminant of used needles and Bacillus subtilis of control needles. The use of antibiotic profilaxis previous to the procedure, significantly reduces the bacterial inoculums. Futures studies are required to increase sample size and control technical errors.

Retinopatía del prematuro: controversias en el uso de antiangiogénicos intraoculares / Retinopathy of prematurity: controversies in the usage of intraocular antiangiogenics

El aumento en la sobrevida de los recién nacidos prematuros, las características del cuidado neonatal y la escasez de programas para la prevención, detección y tratamiento de la retinopatía del prematuro provocan que esta enfermedad sea la principal causa de ceguera infantil prevenible en México. El advenimiento de agentes antiangiogénicos de uso oncológico, y su uso -no autorizado, aunque con buenos resultados- en el tratamiento de enfermedades vaso proliferativas en la retina del paciente adulto, así como la presencia de reportes anecdóticos en la literatura y series de casos con serias fallas metodológicas han sugerido su utilización en el tratamiento de la retinopatía del prematuro. Desafortunadamente, estos agentes, utilizados indiscriminadamente, presentan absorción sistémica y causan efectos secundarios en el organismo del paciente prematuro. Además, no existen estudios de seguimiento a largo plazo que garanticen la seguridad de su uso en esta población. El presente artículo describe la situación en nuestro país y advierte sobre los riesgos de estos medicamentos en la población de pacientes prematuros.

The increase in survival rates among preterm infants, characteristics of neonatal care for such infants and a lack of suitable programs for preventing, detecting and treating retinopathy of prematurity (ROP) are factors that have made this disease the main cause of preventable blindness among children in Mexico. The advent of antiangiogenic agents in cancer treatment and their off-label use with favorable results in the treatment of proliferative vessel disease of the retina among adult patients, as well as anecdotal reports in the literature and a series of cases showing serious methodological flaws, have prompted their use in the treatment of retinopathy of prematurity. Unfortunately, these agents used indiscriminately in our country have a systemic absorption and secondary effects on the preterm patient's body. There are no long-term monitoring studies that guarantee their safe use in this segment of the population. This article describes the situation in our country and warns of the risks posed by the use of this type of drug on the preterm infant population.