Jose Manuel Larrosa

Purpose: To evaluate the 3-year effectiveness and safety of the XEN63 Gel Stent, both as a standalone procedure and combined with phacoemulsification, in patients with primary open-angle glaucoma (POAG). Methods: This prospective, multicenter, non-randomized study included 85 eyes (85 patients) with medically-uncontrolled POAG. Subjects underwent either XEN63-standalone implantation (n = 46) or combined XEN63 + Phacoemulsification (n = 39). The primary endpoint was the cumulative probability of complete success (IOP ≥ 6 and ≥18 mmHg and reduction in IOP ≥ 20% from baseline without ocular-hypotensive medications) at 36 months. Results: At 36-months, the overall surgical success rate was 67.1% (95% CI: 50.8–86.9%), with significant differences between the standalone (78.3%) and combined groups (53.9%; p = 0.0173). Complete success was achieved in 45.9% of the total cohort. Preoperative mean IOP decreased significantly from 21.3 ± 4.7 mmHg to 14.3 ± 4.3 mmHg at the last-follow-up visit (LFUV) (p < 0.0001). Correspondingly, the mean number of medications was significantly reduced from 2.3 ± 0.8 to 0.7 ± 1.0 (p < 0.0001). Multivariable analysis showed that surgical strategy did not significantly influence IOP reduction. Numerical hypotony (IOP < 6 mmHg) occurred in 23.5% of eyes at Day 1 but resolved in 95% of cases by Month 1. One case of hypotonic maculopathy required device explantation. Serious late-onset events included one endophthalmitis (Month 30) and one retinal detachment (Month 26). Secondary needling was required in 8.2% of eyes. Conclusions: The XEN63 Gel Stent provided sustained IOP reduction and a significantly decreased medication burden over 36 months. Outcomes remained consistent regardless of whether the stent was implanted as a standalone procedure or combined with cataract surgery.

Purpose: To create a classification for cataractous eyes based on their ocular biometry and thus provide a standard to stratify eyes when evaluating intraocular lens (IOL) formulas performance in different groups. Setting: High-resolution cataract surgery unit. Design: Monocentric, observational, retrospective study. Methods: Data of 21 797 patients (both eyes explored) were acquired between 2016 and 2024. An exploratory analysis on the most relevant biometric variables determined the presence of uncommon eyes, justifying the need of a stratification. Eyes were classified in 27 subgroups based on axial length (AL), anterior chamber depth (ACD), and mean keratometry (Km). Subgroups were named with 3 letters corresponding to 3 levels—high (H), normal (N), or low (L)—for AL, ACD, and Km, respectively. Cutoffs were created on average ± SD. Linear mixed models were used to evaluate differences between groups, where α < 0.05 meant significant. Results: 43 954 eyes were classified, and all the subgroups contained at least 1 eye. The commonest subgroup was NNN (18 297 eyes, 41.97%), including eyes with (22.13 mm ≤ AL < 24.84 mm) AND (2.64 mm ≤ ACD < 3.43 mm) AND (42.50 diopters [D] ≤ Km < 45.60 D). Rarest subgroups were HLH and LHL (5 eyes and 1, respectively). Subgroups' characteristics (age, lens thickness [LT], LT/ACD, etc) reflect patterns seen frequently in clinical practice, for example, older patients with delayed surgeries, high LT and narrow ACD. Conclusions: There is no consensus on how to subdivide eyes when evaluating IOL power formulas performance. LAKE classification addresses this need by providing a systematic method for categorizing cataractous eyes based on their biometry.

Relevancia: Este trabajo evalúa las repercusiones que ha provocado el uso de mascarilla durante la pandemia del Covid-19, con relación al estado de la superficie ocular, a nivel subjetivo.Propósito: Evaluar la sintomatología compatible con ojo seco en pacientes que portan mascarilla (Síndrome MADE), al comparar las variables medidas subjetivas (cuestionarios) entre pacientes sin mascarilla, con mascarilla y operados de cataratas con mascarilla. Además, se pretendió estudiar algunos síntomas psicológicos en pacientes que portan mascarilla y compararlo con pacientes sin uso de mascarilla.Material y Métodos: Los sujetos eran hombres y mujeres mayores de 18 años. Se excluyeron a todos los sujetos con patologías con repercusión oftalmológica, con alguna alteración de la superficie ocular o que estuviesen en tratamiento ocular tópico distinto a lágrimas artificiales.Se dividió a la población en tres grupos: grupo sano sin mascarilla (64 sujetos), grupo con mascarilla (58 sujetos), grupo con mascarilla operados de catarata hace un mes (36 sujetos).Se realizaron tres preguntas demográficas a todos los pacientes, seguidas de la realización de tres cuestionarios para llevar a cabo el estudio sintomático (test CLDEQ-8 adaptado al uso de mascarilla, OSDI y SANDE), y un cuestionario para evaluar el estado psicológico (test BSI).Resultados: Se apreciaron diferencias estadísticamente significativas en el test de SANDE (p-valor<0.01), al comparar al grupo de sanos con el de portadores de mascarilla sin operar. También se observó un aumento significativo del índice de depresión y psicoticismo en el grupo de portadores de mascarilla respecto al de no portadores. Al comparar el grupo de sanos con el grupo de portadores de mascarilla y operados, se obtuvieron diferencias significativas (p-valor<0.01) en el test de SANDE. No se observaron resultados estadísticamente significativos al comparar entre ambos grupos de portadores de mascarilla.Conclusiones: Los test sintomatológicos sugieren que el uso de mascarillas ha aumentado los síntomas similares a los observados en la EOS respecto a su no uso; confirmándose el síndrome MADE. El aumento del índice de depresión y de psicoticismo en el grupo de portadores de mascarilla respecto al de no portadores podría explicarse por la situación vivida durante todo el confinamiento.

Background: To assess the influence of biometric measurements on the defocus curve after the implantation of enlarged depth-of-focus (EDoF) intraocular lens (IOL). Methods: Patients who underwent cataract surgery with bilateral implantation of Tecnis Symfony IOL were enrolled. Preoperatively, axial length (AL), corneal keratometry (K), pupil size and corneal aberrations were measured. 1 month after surgery, distance, intermediate, and near visual acuities (VA) were recorded. At 3 months, monocular and binocular corrected contrast sensitivities under photopic and mesopic lighting conditions were measured with CSV-1000E test. At 6-months, the defocus curve between −5.00 to + 3.00 diopters (D) was assessed in steps of 0.50 D, and NEI-RQL-42 questionnaire was administered. Results: One hundred thirty one eyes of 66 patients were included. Binocular logMAR VA better than 0.1 for intermediate vision was obtained in 90% of patients, whereas only 17.7% obtained that result in near vision. The rate of satisfaction was high (96%) and most of them (85.5%) had no or little difficulties in near vision. The mean amplitude of the defocus curve was 2.35D ± 0.73D, and smaller AL, smaller pupils, younger age, and male sex were associated with wider range of clear vision. Conclusions: Tecnis Symfony IOL enables functional vision at all distances, but demographic variables and preoperative biometric measurements like AL and pupil size influence the postoperative amplitude of the defocus curve. These parameters could be used to predict the performance of EDoF IOLs.

To evaluate the inner retinal layers in fibromyalgia (FM) patients compared to control subjects using posterior pole protocol (PPole) analysis in optical coherence tomography (OCT) and to correlate...

Purpose of the study: To assess the ability of the new Spectralis Optical Coherence Tomography (OCT) Posterior Pole protocol to detect degeneration of the inner retinal layers in patients with bipolar disorder (BD) and to assess the correlation between the neuroretinal thickness and disease duration.

This clinical investigation compared the clinical performance of two marketed ophthalmic viscoelastic devices (OVDs): the bacterially derived Healon PRO OVD (test) and the animal-derived Healon OVD (control) under normal use conditions during cataract removal and lens implantation. This prospective, multicenter, randomized, parallel, participant/evaluator masked, postmarket investigation enrolled 139 subjects (170 eyes), 116 (143 eyes) of which were treated (73 test; 70 control group). Both test and control OVDs were used, at a minimum, to inflate the anterior chamber and protect the endothelium prior to cataract extraction according to the standard procedure. The surgeon completed a postsurgery OVD clinical performance questionnaire, and intraocular pressure (IOP) was measured before surgery and at the 1 day postoperative visit with Goldmann applanation tonometry. Any IOP measurement of 30 mmHg or higher was considered a “spike” and recorded as a study-specific, serious adverse event. The bacterially derived Healon PRO OVD was found to be statistically noninferior to the overall clinical performance of the animal-derived Healon OVD control; thus, the primary hypothesis was satisfied. There were no statistically significant differences between OVD groups for any of the additional endpoints relating to IOP changes or to safety, thus satisfying additional hypotheses. The Healon PRO OVD showed statistically significant improvements in surgeon ratings for ease of injectability, transparency/visibility, and ease of IOL placement. The safety profile was also similar between OVD groups with regards to serious and/or device-related adverse events, as well as medical and lens findings. The results of this clinical investigation support the safety and effectiveness of the bacterially derived, currently marketed Healon PRO OVD and indicate that the intraocular surgical performance was similar between the two OVDs.

Background: Bruch membrane opening–minimum rim width (BMO–MRW) assessment offers a new diagnostic use in glaucoma patients of the Glaucoma Module Premium Edition (GMPE) available for the Spectralis optical coherence tomography (OCT) system. The objective of our research was to evaluate the diagnostic benefits of examining BMO–MRW and peripapillary retinal nerve fibre layer (pRNFL) readings acquired with Spectralis OCT to distinguish between healthy and mild glaucoma patients, comparing those readings with the standard pRNFL application. Moreover, we investigated whether using a particular combination of BMO–MRW and pRNFL parameters with a linear discriminant function (LDF) could further enhance glaucoma diagnosis. Methods: One hundred thirty-six eyes from 136 individuals were incorporated into this observational, prospective cross-sectional study: 68 mild primary open-angle glaucoma (POAG) patients according to the Hodapp-Parrish-Anderson criteria (mean deviation between 0 and − 6 dB) and 68 healthy control subjects selected by Propensity Score Matching. MRW and pRNFL thickness around the disc (diameters: 3.5 mm, 4.1 mm, and 4.7 mm) were obtained using the BMO–MRW protocol, and pRNFL thickness at 3.5 mm was obtained with the standard glaucoma application. The group data were contrasted. One sample was chosen at random to develop the LDF (teaching set: 34 healthy subjects and 34 POAG patients) using a combination of MRW and pRNFL parameters (acquired with the BMO–MRW protocol); the other sample provided a test of how the LDF performed on an independent group (validating set: 34 healthy subjects and 34 POAG patients). The receiver operating curves (ROCs) were plotted for every measurement and contrasted with the proposed LDF. The OCT parameters with the best area under the receiver operating characteristic curve (AUC) were determined. Results: Global MRW and pRNFL thicknesses were significantly thinner in the POAG group (p < 0.001). The BMO–MRW parameters showed good diagnostic accuracy; the largest AUCs reached 0.875 for the LDF and 0.879 for global RNFL thickness using the standard glaucoma application. There were no statistical differences between the AUCs calculated. Conclusions: BMO–MRW parameters show a strong capability to differentiate between mild glaucoma and control eyes. Our LDF based on the new BMO–MRW OCT protocol did not perform better than isolated parameters.

To assess the reproducibility of retinal and choroidal measurements in the macular and peripapillary areas using swept-source optical coherence tomography in patients with Parkinson's disease. A total of 63 eyes of 63 patients with idiopathic Parkinson's disease were evaluated using a three-dimensional protocol of swept-source optical coherence tomography. The following layers were analyzed: full retinal thickness, retinal nerve fiber layer, ganglion cell layer, and choroid. The coefficient of variation was calculated for every measurement. In the macular area, the mean coefficients of variation of retinal thickness, ganglion cell layer + thickness, and choroidal thickness were 0.40%, 0.84%, and 2.09%, respectively. Regarding the peripapillary area, the mean coefficient of variation of the retinal nerve fiber layer thickness was 2.78. The inferior quadrant showed the highest reproducibility (coefficient of variation= 1.62%), whereas the superonasal sector showed the lowest reproducibility (coefficient of variation= 8.76%). Swept-source optical coherence tomography provides highly reproducible measurements of retinal and choroidal thickness in both the macular and peripapillary areas. The reproducibility is higher in measurements of retinal thickness versus choroidal thickness.

Purpose: To evaluate visual and retinal changes in patients with bipolar disorder. To analyze the correlation between structural changes and visual function parameters.Methods: Thirty patients with bipolar disorder and 80 healthy controls underwent visual function evaluation with Early Treatment Diabetic Retinopathy Study charts at 100%, 2.50%, and 1.25% contrast, Pelli-Robson chart, and color vision Farnsworth and Lanthony tests. Analysis of the different retinal layers was performed using Spectralis optical coherence tomography with automated segmentation software. Correlation analysis between structural and functional parameters was conducted.Results: Patients with bipolar disorder presented worse color vision compared with controls (Lanthony's index,P= 0.002). Full macular thickness, the retinal nerve fiber layer (RNFL), ganglion cell layer, and inner plexiform layer were reduced in patients compared with healthy individuals (P< 0.005). The inner nuclear layer was significantly thickened in patients (P< 0.005). Peripapillary RNFL thickness was reduced in all temporal sectors (P< 0.005). Significant correlations were found between visual acuity and the RNFL thickness, the Pelli-Robson score and the inner plexiform layer, and between the Lanthony's color index and the ganglion cell layer thickness.Conclusion: Patients with bipolar disorder present quantifiable thinning of the macular RNFL, ganglion cell layer, and inner plexiform layer, as well as in the peripapillary RNFL thickness, and increasing thinning in the inner nuclear layer.