Effectiveness and safety of XEN63 in patients with primary-open-angle glaucoma.

This paper evaluates the effectiveness and safety of XEN63 stent, either standalone or in combination with phacoemulsification, in patients with primary open-angle glaucoma (POAG). Eighty eyes from 80 patients with medically uncontrolled POAG were assigned to undergo XEN63 implant. The primary outcome was the surgical success, defined as an intraocular pressure (IOP) lowering from preoperative values ≥ 20% and an IOP absolute value between 6 and 18 mmHg, with or without antiglaucoma medications. Forty-three (53.7%) eyes underwent XEN63-standalone and 37(46.2%) eyes a XEN63 + Phacoemulsification procedure. Success rate was 68.8% (55/80) eyes in the overall study sample, 69.8% (30/43) eyes in the XEN63-standalone group; and 67.6% (25/37) eyes in the XEN63 + Phaco group (p = 0.6133). Preoperative IOP was significantly lowered from 22.1 ± 4.9 mmHg and 19.8 ± 3.7 mmHg to 14.7 ± 5.3 mmHg and 13.8 ± 3.4 mmHg in the XEN63-standalone and XEN63 + Phaco groups, respectively (p < 0.0001 each, respectively); without significant differences between them at any of the time-points measured. Preoperative number of ocular-hypotensive drugs was significantly reduced from 2.3 ± 0.8 to 0.3 ± 0.7 drugs, from 2.5 ± 0.7 to 0.3 ± 0.7 drugs; and from 2.0 ± 0.8 to 0.3 ± 0.7 drugs, in the overall, XEN63-standalone, and XEN63 + Phaco groups, respectively. Regarding safety, 3(42.5%) eyes had transient hypotony at some point during the study, although only in one (1.2%) eye was clinically significant. Four (5.0%) eyes underwent a needling, 4 (5.0%) eyes underwent surgical-bleb-revision, 1 (1.2%) eye required a device replacement and 1 (1.2%) eye a device removal due to maculopathy. XEN63, either alone or in combination with phacoemulsification, significantly lowered IOP and reduced the number of ocular hypotensive medications. The rate of ocular hypotony was relatively high, although it was clinically relevant only in one eye.

XEN Gel Stent Versus Nonpenetrating Deep Sclerectomy in Ocular Hypertension and Open Angle Glaucoma Patients.

PRCIS: XEN gel stent and nonpenetrating deep sclerectomy, both either alone or in combination with cataract surgery, significantly lowered the intraocular pressure (IOP) and reduced the number of antiglaucoma medications in patients with open angle glaucoma, with no significant differences between them. PURPOSE: To compare the surgical outcomes of XEN45 implant and nonpenetrating deep sclerectomy (NPDS), either alone or in combination with cataract surgery, in patients with ocular hypertension and open angle glaucoma (OAG). A retrospective and single-center cohort study was conducted on consecutive patients who underwent a XEN45 implant or an NPDS, either alone or in combination with phacoemulsification. The primary endpoint was the mean change in IOP from the baseline to the last follow-up visit. One hundred twenty-eight eyes, 65 (50.8%) eyes in the NPDS group and 63 (49.2%) eyes in the XEN group, were included in the study. The mean preoperative IOP was significantly lowered from 17.6±5.3 mm Hg and 17.8±6.2 mm Hg to 12.6±2.6 mm Hg and 13.8±2.8 mm Hg at month 12 in the XEN and NPDS groups, respectively; P <0.0001 each. At month 12, 70 (54.7%) eyes were classified as a success, with no significant differences between XEN (57.1%; 36/63 eyes) and NPDS (52.3%; 34/65 eyes) (mean difference: 4.8%; 95% CI: -30.5% to 20.8%; P =0.7115). The number of ocular hypotensive medications was significantly reduced in the XEN (from 2.1±0.7-0.2±0.5, P <0.0001) and in the NPDS (from 2.0±0.8 to 0.3±0.6, P <0.0001) groups, with no significant differences between them ( P =0.2629). The incidence of postoperative adverse events in the overall study population was 12.5%, with no significant differences between groups ( P =0.1275). Seven (11.1%) eyes underwent needling (XEN group) and 10 (15.4%) goniopuncture (NPDS group); P =0.4753. CONCLUSIONS: XEN45 implant and the NPDS, either alone or in combination with cataract surgery, significantly lowered IOP and reduced the number of ocular hypotensive medications in ocular hypertension and patients with open angle glaucoma.

Impact of Primary Needling on the XEN Implant Clinical Outcomes: A Real-Life Retrospective Study.

Purpose: To assess the effectiveness and safety of primary-needling in eyes who underwent a XEN45 implant. Methods: Retrospective and single center study. Consecutive patients with early-to-moderate open-angle glaucoma (OAG) or ocular hypertension, who underwent XEN45 surgery, either alone or combined with phacoemulsification, and had at least a valid 12-month post-operative visit, were included in the study. Primary needling was performed by using a 30-gauge needle without viscoelastic. Subjects were divided in two groups: Eyes who underwent XEN+primary-needling (needling) and those who underwent XEN without primary-needling (no-needling). The primary end-point was the mean change in IOP from baseline to the last follow-up visit. Results: Sixty-three eyes, 19 (30.2%) in the needling group and 44 (69.8%) in the no-needling one, were included in the study. There were not significant differences in mean IOP lowering between needling and no-needling groups at month-12 (mean difference -2.5±5.3 mm Hg, p=0.0926). No significant differences in mean reduction of ocular-hypotensive medications were observed between needling and no-needling groups, p=0.8690. At month-12, 50 (80.6%) had blebs considered as functioning, with no difference between groups, p = 0.5631. At month-12, 59 (93.7%) eyes were classified as success, with no significant differences between needling (17/19) and no-needling (42/44) groups, p=0.3754. Secondary needling was performed in 8 (12.7%) eyes, without differences between groups (p=0.6333). Conclusion: Primary needling, at the time of surgery, was a safe procedure in OAG patients who underwent a XEN implant, although it was not associated with a lower postoperative IOP or less ocular hypotensive medications.

Does mitomycin-C concentration have any influence on XEN45 gel stent outcomes in a real-world setting?

BACKGROUND: To compare the effectiveness and safety of XEN45 implanted with mitomycin-C (MMC) 0.01% versus (vs) XEN45 implanted with MMC 0.02%. METHODS: Retrospective and single-center study conducted on consecutive patients with open-angle glaucoma or ocular hypertension who underwent XEN45-implant, either alone or in combination with cataract surgery. The primary end-point was the mean change in intraocular pressure (IOP) from baseline to the last follow-up visit. RESULTS: Fifty-five patients (63 eyes) were included. Thirty-seven (58.7%) eyes underwent surgery with MMC 0.01% and 26 (41.3%) ones with MMC 0.02%. In the overall study sample, the mean (standard error) IOP was significantly lowered from 17.6 (0.7) mm Hg at baseline to 12.6 (0.3) mm Hg at month 12. The IOP was significantly lowered from 17.3 (15.4 to 19.2) mm Hg and 17.9 (16.1 to 17.8) mm Hg at baseline to 12.3 (11.3 to 13.3) mm Hg and 13.1 (12.3 to 13.9) mm Hg at month 12 in the MMC 0.01% and MMC 0.02% groups, respectively; p < 0.0001 each. The mean number of ocular-hypotensive medications significantly decreased from 2.1 (1.9 to 2.3) at baseline to 0.2 (0.04 to 0.3) at month 12, p < 0.0001, with no significant differences between MMC 0.01% and MMC 0.02% groups, p = 0.5181. At month 12, 50 (80.6%) eyes had functioning blebs. Regarding safety, 18 (28.6%) eyes have experience adverse events. CONCLUSION: XEN45, either alone or in combination with cataract surgery, showed a good effectiveness and safety profile. MMC dose had no influence on the IOP lowering, which may support the use of the lowest dose.

Management of the leakage of aqueous humour caused by the wound in a cataract surgery post-operative period with Nd:YAG laser.

PURPOSE: To describe a new technique for sealing aqueous leakage after cataract surgery using Nd:YAG laser. INTRODUCTION: The leakage of aqueous humour through the corneal incisions after a surgical procedure still is one of the main complications in the cataract surgery post-operative period. Its cause depends on multiple factors, among which we find the structure of the incision. Several methods to treat its ending have been proposed over the years, and there is not a definitive and standardised method. Although most of the times they are mild and self-limited, in the cases in which the aqueous humour leakage is more profuse, a treatment is needed to avoid the risk of other complications, mainly contaminations that cause infections. METHODS: The technique consists of generating intrastromal microbubbles with the Nd:YAG laser to increase the pressure against the tunnel, achieving its sealing. It is applied on the corneal stroma, next to the incision plane. Power is set between 1.5 and 2.0 mJ (millijoules), with offset set to 0, and normally between four and six single shots would be sufficient. RESULTS: We have achieved the closure in all the patients that we performed this procedure so far. CONCLUSIONS: We describe an easy and very effective technique for the sealing of the incision with an aqueous humour leakage in the immediate post-operative period of the cataract surgery by using the YAG:Nd laser, allowing a prompt and accessible treatment with a good safety profile, and reducing the need for new procedures and additional check-ups.

High interpretable machine learning classifier for early glaucoma diagnosis.

AIM: To develop a classifier for differentiating between healthy and early stage glaucoma eyes based on peripapillary retinal nerve fiber layer (RNFL) thicknesses measured with optical coherence tomography (OCT), using machine learning algorithms with a high interpretability. METHODS: Ninety patients with early glaucoma and 85 healthy eyes were included. Early glaucoma eyes showed a visual field (VF) defect with mean deviation >-6.00 dB and characteristic glaucomatous morphology. RNFL thickness in every quadrant, clock-hour and average thickness were used to feed machine learning algorithms. Cluster analysis was conducted to detect and exclude outliers. Tree gradient boosting algorithms were used to calculate the importance of parameters on the classifier and to check the relation between their values and its impact on the classifier. Parameters with the lowest importance were excluded and a weighted decision tree analysis was applied to obtain an interpretable classifier. Area under the ROC curve (AUC), accuracy and generalization ability of the model were estimated using cross validation techniques. RESULTS: Average and 7 clock-hour RNFL thicknesses were the parameters with the highest importance. Correlation between parameter values and impact on classification displayed a stepped pattern for average thickness. Decision tree model revealed that average thickness lower than 82 µm was a high predictor for early glaucoma. Model scores had AUC of 0.953 (95%CI: 0.903-0998), with an accuracy of 89%. CONCLUSION: Gradient boosting methods provide accurate and highly interpretable classifiers to discriminate between early glaucoma and healthy eyes. Average and 7-hour RNFL thicknesses have the best discriminant power.

Valoración de la formación de postimágenes mediante una nueva aplicación informática en pacientes con neuropatías ópticas desmielinizantes / Appraisal of the formation of afterimages by means of a new computer application in patients with demyelinating optic neuropathies

Introducción. En las neuritis ópticas se afecta, entre otras funciones visuales, la percepción del color. La mayoría de las pruebas existentes para evaluar discromatopsias se basa en evaluar el matiz, pero no se ha estudiado clínicamente la formación de postimágenes en la retina en estos pacientes. Objetivo. Evaluar la discromatopsia adquirida en las neuritis ópticas desmielinizantes mediante la formación de postimágenes en la retina. Sujetos y métodos. Estudio observacional, transversal, de casos y controles. Los casos son pacientes con al menos un episodio de neuritis óptica y esclerosis múltiple confirmada. Se seleccionó un control sano por cada caso, emparejado por edad y sexo. La variable principal es la capacidad de ver postimágenes tras saturar los fotorreceptores retinianos. Para evaluar dicho fenómeno se desarrolló una aplicación informática específica. Resultados. La muestra comprende 30 casos y 30 controles (63% mujeres; edad media: 33 años; rango: 18-48 años). Los casos mostraron menor probabilidad de ver la postimagen (el 36,6% de los casos y ningún control no veían postimagen) y, en caso de verla, una menor permanencia de ella. La curva ROC muestra una sensibilidad del 86,3% y una especificidad del 83,3%. La odds ratio era de 5 (intervalo de confianza al 95%: 2,21-11,3) para la probabilidad de ver la postimagen en los controles frente a los casos. Conclusiones. Los pacientes con al menos un episodio de neuritis óptica presentan una menor capacidad de observar postimágenes, por lo que la prueba es útil para la evaluación y el seguimiento del daño funcional en neuropatías ópticas desmielinizantes (AU)

Introduction. The perception of colour is one of the visual functions affected by optic neuritis. Most of the tests currently available for evaluating dichromatism are based on assessing the hue, but no clinical studies have been conducted to investigate the formation of afterimages on the retina of these patients. Aims. To evaluate the dichromatism acquired in demyelinating optic neuritis by means of the formation of afterimages on the retina. Subjects and methods. This is an observation-based, cross-sectional, case-control study. The cases are patients with at least one bout of optic neuritis and confirmed multiple sclerosis. A healthy age- and sex-paired control was selected for each case. The main variable is the capacity to see afterimages after saturation of the retinal photoreceptor cells. A specific computer application was developed to evaluate this phenomenon. Results. The sample consisted of 30 cases and 30 controls (63% females; mean age: 33 years; range: 18-48 years). The cases showed less probability of seeing the afterimage (36.6% of the cases, while none of the controls failed to see an afterimage) and, if it was seen, it remained for less time. The ROC curve shows a sensitivity of 86.3% and a specificity of 83.3%. The odds ratio was 5 (95% confidence interval: 2.21-11.3) for the probability of seeing the afterimage in controls versus cases. Conclusions. Patients with at least one episode of optic neuritis presented a lower capacity to observe afterimages. The test is therefore useful in the assessment and follow-up of functional damage in demyelinating optic neuropathies (AU)

Xeroftalmía bilateral por déficit de vitamina A secundario a cirugía bariátrica / Bilateral xerophthalmia due to hypovitaminosis A after bariatric surgery

Es bien conocido que la cirugía bariátrica no está exenta de complicaciones, en especial las técnicas de hipoabsorción. Sin embargo, en la práctica clínica la pérdida de visión por déficit de vitamina A como complicación nutricional de este tipo de cirugía es poco habitual. Presentamos el caso de una paciente de 56 años con xeroftalmía bilateral con perforación corneal del ojo izquierdo y disminución de la agudeza visual bilateral después de ser sometida a cirugía bariátrica (derivación biliopancreática tipo Scopinaro) por obesidad mórbida. A pesar del tratamiento sustitutivo con altas dosis de vitamina A, la pérdida de visión del ojo izquierdo es prácticamente total (AU)

It is well known the bariatric surgery is not without complications, particularly malabsorptive techniques. However, loss of vision due to vitamin A deficiency as a nutritional complication of this type of surgery is rare in clinical practice. We report the case of a 56-year-old woman with bilateral xerophthalmia, left corneal perforation and reduced bilateral visual acuity following bariatric surgery (Scopinaro type biliopancreatic diversion) for morbid obesity. Despite treatment with very high doses of vitamin A supplements, the loss of vision in the left eye was practically complete (AU)