A randomised study comparing performance and safety of Eyestil Plus® vs Vismed Multi® in moderate-to-severe dry eye syndrome patients.

PURPOSE: This clinical investigation compared the performance and safety of Eyestil Plus® (SIFI) and Vismed Multi® (TRB Chemedica) for reducing keratitis lesions in moderate-to-severe dry eye disease (DED) patients. MATERIALS AND METHODS: This was a randomised, double-blind, multicentre investigation. 96 adults (>18 years of age) with moderate-to-severe DED received Eyestil Plus® (N = 48) or Vismed Multi® (n = 48) 6 times daily for 3 months. The primary objective clinical performance after 1 month as global corneal and conjunctival staining scores. The secondary objectives were clinical performance after 3 months, tear film stability (tear break up time (TBUT), tear production (Schirmer test), patient-reported outcomes (PROs), investigator satisfaction, and safety. RESULTS: 96 participants were randomised to receive the clinical investigations' treatments, 82.3% of them were female and their mean age was 65.8 years. The non-inferiority of Eyestil Plus® for moderate-to-severe DED was demonstrated at 1 month. No statistical difference was found for any of the study's objectives: change at 1 and 3 months of the global corneal and conjunctival staining score (p-value = 0.506 and 0.661, respectively), change at 1 and 3 months (p-value = 0.538 and 0.302) for TBUT test; change at 3 months for Schirmer test (p-value = 0.540). There were no changes for PROs either. Investigator satisfaction was high for both products. 16.6% of the participants experienced adverse events. CONCLUSION: This clinical investigation showed the non-inferiority of Eyestil Plus® compared to Vismed Multi® regarding performance and safety in a moderate-to-severe DED population.

State of refractive surgery with Visian ICL posterior chamber phakic lens in Spain.

OBJECTIVES: To analyse the state of refractive surgery with Visian ICL phakic lens implantation in Spain, indicating the mean ranges of implanted powers, visual and refractive outcomes obtained and safety and efficacy indices. METHOD: This is a population-based, cross-sectional, descriptive, analytical, retrospective, multicentre study in which each co-author collected data from at least the last 10 patients (up to a maximum of 30) with Visian ICL phakic lens implantation. One eye from each subject was randomly selected for study inclusion, and the variables analysed were: age, gender, visual acuities with and without correction pre and post-surgery, preoperative and residualrefraction, keratometry, endothelial cellular density, anterior chamber depth from endothelium, central corneal pachymetry, intraocular pressure, white-white, implanted lens (power and size), expected and achieved spherical equivalent (SEQ) post-surgery at one month after surgery. RESULTS: A sample of 140 eyes was obtained from 140 patients with a mean age of 31.35 ± 7.28 years. Mean preoperative SEQ was -6.33 ± 3.69D, mean CDVA was 0.96 ± 0.16, ACD was 3.30 ± 0.29 mm, WTW 12.02 ± 0.40 mm, CCT 535.03 ± 37.68 µm, ECD 2684.37 ± 313.74 cels/mm2 and IOP 14.84 ± 2.59 mmHg. 66.4% of the implanted lenses were spherical ICLs and 33.6% toric, with a mean power of -7.81 ± 4.09D and a mean cylinder of 2.27 ± 1.23D. 5.7% of the implanted lenses were hypermetropic. The mean SEQ target selected was +0.04 ± 0.27D. 48.92% of the implanted lenses were of size 13.2 mm, with the remaining 36.69, 10.79 and 3.60% being of sizes 12.6, 12.1 and 13.7 mm, respectively. At one month after surgery a residual SEQ of -0.01 ± 0.31D was obtained. The efficacy and safety indices were 1.06 ± 0.18 and 1.10 ± 0.19, respectively. The mean central vault was 508.80 ± 201.04 µm. The accuracy between the calculated SEQ and the obtained SEQ was 99.3% for spherical lenses and 88.2% for Cyl correction. The mean ECD at 1 month after surgery was 2805.53±273.30céls/mm2, which was a difference from preoperative of 0.11% (p = 0.922), similarly, the mean IOP was 13.98 ± 2.57 mmHg, which was a difference of -0.92 ± 2.80 mmHg. CONCLUSIONS: ICL phakic lens surgery is an effective, safe and predictable procedure. There were no significant changes in endothelial cell count or intraocular pressure measurement one month after surgery.

Early Penetrating Keratoplasty after interface fungal keratitis in Descemet Membrane Endothelial Keratoplasty. / Queratoplastia penetrante temprana después de queratitis fúngica de la interface en la queratoplastia endotelial de la membrana de Descemet.

In this case-report we describe the first reported case of early-onset fungal interface keratitis (IK) after Descemet Membrane Endothelial Keratoplasty (DMEK) successfully treated with penetrating keratoplasty (PK) during the active stage of infection. A patient with graft failure after Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) was operated on with DMEK. Donor rim culture and broth were positive for Candida albicans. Several interface infiltrates were confirmed and localized using anterior segment optical coherence tomography. Three days after diagnosis, observing clear signs of intraocular infection, the graft was removed with simultaneous washed-up of anterior chamber with fluconazole 1% followed by a PK and intrastromal corneal injections of fluconazole. A best-corrected visual acuity of 20/20 was achieved. This case highlights the importance of analysing every donor rim and broth, despite the patient doesn't show any symptoms or signs during the post-operative period. PK is a viable treatment option in early-onset interface keratitis.

[Corneal transplantation in keratoconus: penetrating keratoplasty versus deep anterior lamellar keratoplasty with Melles technique]. / Trasplante de córnea en queratocono: queratoplastia penetrante versus queratoplastia lamelar anterior profunda con técnica de Melles.

OBJECTIVES: To evaluate the effectiveness of deep anterior lamellar keratoplasty (DALK) using Melles technique (technique B) in patients with advanced keratoconus versus a classic technique, penetrating keratoplasty (technique A). METHODOLOGY: Retrospective descriptive comparative study between technique A and technique B in homogeneous groups. RESULTS: Best corrected visual acuity (Snellen test decimal scale) was 0.77±0.32 for group A and 0.62±0.29 for group B, with no statistically significant differences. The mean spherical final refraction in group A was 1.73±5.1 diopters, and the mean spherical equivalent was -3.92±5.1. Technique B group gave values -2.67±4.02 diopters and -4.55±4.08 diopters, respectively, with no statistically significant differences. The residual cylinder after removal of the sutures was 4.47±2.47 diopters for group A and 3.77±1.63 for group B, with no statistically significant differences. CONCLUSION: No statistically significant differences were found for any of the studied variables when comparing both groups using the t -test for independent samples. More studies on the homogeneity and residual stromal bed thickness could provide the key to determine whether this technique is closer to the visual acuity of penetrating keratoplasty or DALK by a descemet technique.

Estado de la cirugía refractiva con lente intraocular fáquica de cámara posterior Visian ICL en España / State of refractive surgery with Visian ICL posterior chamber phakic lens in Spain

Objetivos Analizar la situación actual de la cirugía refractiva con implante de lente fáquica Visian ICL en España, señalando los rangos medios de potencias implantadas, los resultados visuales y refractivos obtenidos y los índices de seguridad y eficacia. Método Se trata de un estudio de población, transversal, descriptivo, analítico, retrospectivo, multicéntrico, en el que cada coautor recopiló los datos de, al menos, los 10 últimos pacientes (hasta un máximo de 30) con implante de lente fáquica Visian ICL. Se eligió aleatoriamente un ojo de cada sujeto para incluirlo en el estudio, y se analizaron las variables: edad, género, agudezas visuales sin corrección y con corrección pre y posquirúrgica, refracción preoperatoria y residual, queratometrías, recuento endotelial, profundidad de cámara anterior desde endotelio, paquimetría corneal central, presión intraocular, distancia blanco-blanco, lente implantada (potencia y talla) y equivalente esférico (SEQ) esperado y obtenido posquirúrgico al mes de la cirugía. Resultados Se obtuvo una muestra de 140 ojos de 140 pacientes con una edad media de 31,35±7,28 años. El SEQ preoperatorio medio fue de −6,33±3,69, la agudeza visual con corrección media de 0,96±0,16, la profundidad de cámara anterior desde endotelio de 3,30±0,29mm, distancia blanco-blanco 12,02±0,40mm, paquimetría corneal central 535,03±37,68μm, recuento endotelial 2.684,37±313,74céls/mm2 y presión intraocular 14,84±2,59mmHg. El 66,4% de las lentes implantadas fueron ICL esféricas y el 33,6% tóricas, con una potencia media de −7,81±4,09D y un cilindro medio de 2,27±1,23D. El 5,7% fueron hipermetrópicas. El 45,69% de las lentes implantadas eran de la talla 13,2mm, siendo el 37,93, 12,93 y 3,45% restante de las tallas 12,6, 12,1 y 13,7mm, respectivamente. Al mes de la cirugía se obtuvo un SEQ residual de −0,01±0,31D. Los índices de eficacia y seguridad fueron de 1,06±0,18 y 1,10±0,19, respectivamente... (AU)

Objectives To analyse the state of refractive surgery with Visian ICL phakic lens implantation in Spain, indicating the mean ranges of implanted powers, visual and refractive outcomes obtained and safety and efficacy indices. Method This is a population-based, cross-sectional, descriptive, analytical, retrospective, multicentre study in which each co-author collected data from at least the last 10 patients (up to a maximum of 30) with Visian ICL phakic lens implantation. One eye from each subject was randomly selected for study inclusion, and the variables analysed were: age, gender, visual acuities with and without correction pre and post-surgery, preoperative and residual refraction, keratometry, endothelial cellular density, anterior chamber depth from endothelium, central corneal pachymetry, intraocular pressure, white-white, implanted lens (power and size), expected and achieved spherical equivalent (SEQ) post-surgery at one month after surgery. Results A sample of 140 eyes was obtained from 140 patients with a mean age of 31.35±7.28 years. Mean preoperative SEQ was −6.33±3.69D, mean visual acuities with correction was 0.96±0.16, anterior chamber depth was 3.30±0.29mm, white-white 12.02±0.40mm, central corneal pachymetry 535.03±37.68μm, endothelial cellular density 2684.37±313.74cels/mm2 and intraocular pressure 14.84±2.59mmHg. A percentage of 66.4 of the implanted lenses were spherical ICLs and 33.6% toric, with a mean power of −7.81±4.09D and a mean cylinder of 2.27±1.23D. A percentage of 5.7 of the implanted lenses were hypermetropic. The mean SEQ target selected was +0.04±0.27D. A percentage of 45.69 of the implanted lenses were of size 13.2mm, with the remaining 37.93, 12.93 and 3.45% being of sizes 12.6, 12.1 and 13.7mm, respectively. At one month after surgery a residual SEQ of −0.01±0.31D was obtained. The efficacy and safety indices were 1.06±0.18 and 1.10±0.19...(AU)

Queratoplastia penetrante temprana después de queratitis fúngica de la interface en la queratoplastia endotelial de la membrana de Descemet / Early Penetrating Keratoplasty after interface fungal keratitis in Descemet Membrane Endothelial Keratoplasty

Este caso clínico describe el primer caso publicado de queratitis fúngica de la interfaz (QI) de inicio temprano después de una queratoplastia endotelial de la membrana de Descemet (DMEK) tratada satisfactoriamente con queratoplastia penetrante (QP) durante la etapa activa de la infección. Un paciente con fracaso de injerto después de una queratoplastia endotelial automatizada con pelado de Descemet (DSAEK) fue intervenido con DMEK. El cultivo y el medio de cultivo del donante dieron positivo para Candida albicans. Se confirmaron y localizaron varios infiltrados de la interface utilizando tomografía de coherencia óptica de segmento anterior. Tres días después del diagnóstico, observándose signos claros de infección intraocular, se retiró el injerto con lavado simultáneo de cámara anterior con fluconazol al 1% seguido de una QP e inyecciones corneales intraestromales de fluconazol. Se consiguió una mejor agudeza visual corregida de 20/20. Este caso resalta la importancia de analizar cada pieza y medio de cultivo de donantes a pesar de que el paciente no exhiba síntomas o signos durante el periodo posoperatorio. La QP es una opción de tratamiento viable para la queratitis de interface de inicio temprano

In this case-report we describe the first reported case of early-onset fungal interface keratitis (IK) after Descemet Membrane Endothelial Keratoplasty (DMEK) successfully treated with penetrating keratoplasty (PK) during the active stage of infection. A patient with graft failure after Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) was operated on with DMEK. Donor rim culture and broth were positive for Candida albicans. Several interface infiltrates were confirmed and localized using anterior segment optical coherence tomography. Three days after diagnosis, observing clear signs of intraocular infection, the graft was removed with simultaneous washed-up of anterior chamber with fluconazole 1% followed by a PK and intrastromal corneal injections of fluconazole. A best-corrected visual acuity of 20/20 was achieved. This case highlights the importance of analysing every donor rim and broth, despite the patient doesn't show any symptoms or signs during the post-operative period. PK is a viable treatment option in early-onset interface keratitis

Necesidad de una disponibilidad real de fármacos oculares tópicos antifúngicos y antiamebianos en el Sistema Sanitario Español / Need for real availability of topical anti-fungal and anti-amoeba eye drugs in the Spanish Health System

No disponible

Las capas profundas de la córnea y la investigación básica en España / Deep layers of the cornea and basic research in Spain

No disponible

Trasplante de córnea en queratocono: queratoplastia penetrante versus queratoplastia lamelar anterior profunda con técnica de Melles / Corneal transplantation in keratoconus: Penetrating keratoplasty versus deep anterior lamellar keratoplasty with Melles technique

OBJETIVOS: Evaluar la eficacia de la queratoplastia lamelar anterior profunda (DALK) mediante técnica de Melles (técnica B) en pacientes con queratocono avanzado en comparación con la técnica clásica de queratoplastia penetrante (QPP) (técnica A). METODOLOGÍA: Estudio retrospectivo descriptivo comparativo entre la técnica A y la técnica B en grupos homogéneos. RESULTADOS: La agudeza visual con corrección (test de Snellen, escala decimal) ha sido de 0,77 ± 0,32 para el grupo A y de 0,62 ± 0,29 para el grupo B, no siendo diferencias estadísticamente significativas. El defecto refractivo esférico medio en el grupo A fue de −1,73 ± 5,1 dioptrías y el equivalente esférico medio de −3,92 ± 5,1 dioptrías. El grupo B presentó valores de −2,67 ± 4,02 dioptrías y −4,55 ± 4,08 dioptrías, respectivamente, no habiendo diferencias para estas variables en ambos grupos. El cilindro residual una vez retiradas las suturas fue de 4,47 ± 2,47 dioptrías para el grupo A y de 3,77 ± 1,63 dioptrías para el grupo B, sin ser estadísticamente significativas. CONCLUSIÓN: No se han encontrado diferencias estadísticamente significativas para ninguna de las variables estudiadas al comparar ambos grupos mediante la t de Student para muestras independientes. Más estudios acerca de la homogeneidad del lecho estromal residual y del espesor del mismo pueden aportar las claves para que esta técnica se acerque a las agudezas visuales de una QPP o una DALK mediante técnica descemética

OBJECTIVES: To evaluate the effectiveness of deep anterior lamellar keratoplasty (DALK) using Melles technique (technique B) in patients with advanced keratoconus versus a classic technique, penetrating keratoplasty (technique A). METHODOLOGY: Retrospective descriptive comparative study between technique A and technique B in homogeneous groups. RESULTS: Best corrected visual acuity (Snellen test decimal scale) was 0.77 ± 0.32 for group A and 0.62 ± 0.29 for group B, with no statistically significant differences. The mean spherical final refraction in group A was 1.73 ± 5.1 diopters, and the mean spherical equivalent was −3.92 ± 5.1. Technique B group gave values -2.67 ± 4.02 diopters and −4.55 ± 4.08 diopters, respectively, with no statistically significant differences. The residual cylinder after removal of the sutures was 4.47 ± 2.47 diopters for group A and 3.77 ± 1.63 for group B, with no statistically significant differences. CONCLUSION: No statistically significant differences were found for any of the studied variables when comparing both groups using the t -test for independent samples. More studies on the homogeneity and residual stromal bed thickness could provide the key to determine whether this technique is closer to the visual acuity of penetrating keratoplasty or DALK by a descemet technique