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11 result(s) for "Zalewski, Dominik"
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Physiological determinants of cortical P100 responses in pattern visual evoked potentials: a scoping review
Pattern visual evoked potentials (pattern VEP) are widely used for functional assessment of the visual pathways. The P100 component represents the principal clinical parameter owing to its relative interindividual stability and diagnostic value. However, both latency and amplitude are modulated by multiple physiological and environmental factors, which complicates interpretation and the establishment of reliable reference standards. This scoping review aimed to systematically map determinants of P100 parameters in healthy individuals. The review was conducted in accordance with PRISMA-ScR and Joanna Briggs Institute methodology. Databases were searched for studies published between 2015 and 2025 that examined biological, refractive, anthropometric, metabolic, or environmental influences on pattern VEP parameters in healthy populations. Owing to methodological heterogeneity, findings were synthesized descriptively. Thirty-nine studies met the inclusion criteria. Age emerged as the most consistent determinant of P100 parameters. Latency followed a non-linear trajectory across the lifespan, with shortening during maturation, stabilization in early adulthood, and progressive prolongation after approximately 40 years of age, whereas amplitude generally declined with aging. Sex differences predominantly affected amplitude, with women typically demonstrating higher P100 or N75-P100 amplitudes in adult populations; latency differences were less consistent and often minimal in paediatric cohorts. Retinal image quality exerted a strong dose-dependent effect on P100 parameters: increasing refractive blur and higher-order aberrations were associated with progressive latency prolongation and amplitude reduction, particularly for small check sizes. Ocular dominance showed no clinically meaningful interocular asymmetry. Metabolic disturbances were associated with prolonged latency in selected populations, whereas anthropometric variables such as head size and height demonstrated weak or inconsistent associations. Among environmental factors, acute alcohol intake prolonged P100 latency, while moderate caffeine consumption had no significant effect. Age and retinal image quality represent the primary physiological determinants of P100 latency and amplitude in healthy individuals. Most other modifiers exert modest or context-dependent effects. Consideration of these variables is essential for accurate interpretation of pattern VEP recordings and for establishing reliable local reference standards consistent with ISCEV recommendations.
Comparison of Visual Acuity Outcomes of Enhanced Monofocal Versus Standard Monofocal Intraocular Lenses from a Randomized, Multicenter, Active-Controlled Trial
Purpose To compare visual performance of the Vivinex Impress enhanced monofocal intraocular lens (IOL) (HOYA Surgical Optics) with the Acrysof IQ monofocal IOL (Alcon Laboratories, Inc). Methods In this multicenter, active-controlled trial, participants were randomized 2:1 to bilateral implantation with the enhanced monofocal (test) or standard monofocal (control) IOL and examined through 12 months postoperatively for visual acuities, refractive outcomes, defocus curves, and pupil diameters. Results Ninety-eight test and 46 control participants completed testing for the first implanted eye. The test arm demonstrated a statistically significant benefit in monocular distance-corrected intermediate visual acuity (DCIVA) (photopic: 1.2 lines, P < .001; mesopic: 0.7 lines, P = .01) and uncorrected intermediate visual acuity (0.8 lines; P < .001) but no significant difference in monocular corrected distance visual acuity (P = .07). Using a stepwise regression analysis for DCIVA, the final model (adjusted R-square, 0.31) identified three significant predictor variables (age, pupil diameter, and treatment arm). Photopic defocus curves showed the test arm produced better monocular visual acuity from −1.00 through −2.50 D than the control arm. The intermediate vision benefit of the test IOL is independent of pupil size and axial length. Cumulative and persistent adverse events for the test IOL did not exceed the Safety and Performance Endpoint rates per International Organization for Standardization 11979-7. Conclusions Compared to a standard monofocal IOL, the Vivinex Impress enhanced monofocal IOL offers an extended range of vision, with significant improvements in intermediate vision and a DCIVA benefit unaffected by pupil size and axial length. This IOL is safe and effective for patients seeking improved intermediate vision following cataract surgery. [J Refract Surg. 2025;41(4):e300–e309.]
Five-Month Observation of Persistent Diabetic Macular Edema after Intravitreal Injection of Ozurdex Implant
Aims. This retrospective analysis was aimed at evaluating the effectiveness of treatment of persistent diabetic macular edema with intravitreal injections of 0.7 mg dexamethasone implant Ozurdex. The study comprised three male patients (6 eyes). Results. The average thickness of the retina at baseline was 632 μm, the medial BCVA was 0.8 logMAR, and corrected intraocular pressure was 13.7 mmHg. The maximum decrease in mean retinal thickness was observed at four weeks following the treatment and was 365 μm (−267 μm) and visual acuity improved by an average of two lines and was 0.6 logMAR. The largest increase in mean retinal thickness to average of 528 μm (+164 μm) occurred at 16 weeks and the average BCVA was 0.614 lines BCVA logMAR. In one eye, there was a steroid cataract development after the third dose of dexamethasone implant of 0.7 mg. Conclusions. The intravitreal dexamethasone implant treatment of patients with persistent diabetic macular edema in whom laser photocoagulation proved to be ineffective and as a result they required a monthly injection of anti-VEGF factors (Ranibizumab, Bevacizumab) may be a good alternative to extending the interval of injections. However, reinjections involve a high risk of developing poststeroid cataracts, which is not without significance in middle-aged patients.
Current Trends in the Monitoring and Treatment of Diabetic Retinopathy in Young Adults
The diagnosis and treatment of diabetic retinopathy (DR) in young adults have significantly improved in recent years. Research methods have widened significantly, for example, by introducing spectral optical tomography of the eye. Invasive diagnostics, for example, fluorescein angiography, are done less frequently. The early introduction of an insulin pump to improve the administration of insulin is likely to delay the development of diabetic retinopathy, which is particularly important for young patients with type 1 diabetes mellitus (T1DM). The first years of diabetes occurring during childhood and youth are the most appropriate to introduce proper therapeutic intervention before any irreversible changes in the eyes appear. The treatment of DR includes increased metabolic control, laserotherapy, pharmacological treatment (antiangiogenic and anti-inflammatory treatment, enzymatic vitreolysis, and intravitreal injections), and surgery. This paper summarizes the up-to-date developments in the diagnostics and treatment of DR. In the literature search, authors used online databases, PubMed, and clinitrials.gov and browsed through individual ophthalmology journals, books, and leading pharmaceutical company websites.
Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes
Background/AimsTo provide longer-term data on efficacy, safety, immunogenicity and pharmacokinetics (PK) of ranibizumab biosimilar SB11 compared with the reference ranibizumab (RBZ) in patients with neovascular age-related macular degeneration (nAMD).Methods Setting: Multicentre. Design: Randomised, double-masked, parallel-group, phase III equivalence study. Patient population: ≥50 years old participants with nAMD (n=705), one ‘study eye’. Intervention: 1:1 randomisation to monthly intravitreal injection of 0.5 mg SB11 or RBZ. Main outcome measures: Visual efficacy endpoints, safety, immunogenicity and PK up to 52 weeks.ResultsBaseline and disease characteristics were comparable between treatment groups. Of 705 randomised participants (SB11: n=351; RBZ: n=354), 634 participants (89.9%; SB11: n=307; RBZ: n=327) completed the study until week 52. Previously reported equivalence in primary efficacy remained stable up to week 52 and were comparable between SB11 and RBZ. The adjusted treatment difference between SB11 and RBZ in full analysis set at week 52 of change from baseline in best-corrected visual acuity was −0.6 letters (90% CI −2.1 to 0.9) and of change from baseline in central subfield thickness was −14.9 µm (95% CI –25.3 to –4.5). The incidence of ocular treatment-emergent adverse events (TEAEs) (SB11: 32.0% vs RBZ: 29.7%) and serious ocular TEAE (SB11: 2.9% vs RBZ: 2.3%) appeared comparable between treatment groups, and no new safety concerns were observed. The PK and immunogenicity profiles were comparable, with a 4.2% and 5.5% cumulative incidence of antidrug antibodies up to week 52 for SB11 and RBZ, respectively.ConclusionsLonger-term results of this study further support the biosimilarity established between SB11 and RBZ.
Safety and Longevity of Intraocular Pressure Control After Bimatoprost Implant Administration: Interim Analysis of a Phase 3b Clinical Trial (TRITON)
Bimatoprost implant 10 µg is an intracameral, biodegradable implant that slowly releases bimatoprost to lower intraocular pressure (IOP). This study was designed to evaluate safety and the duration of the IOP-lowering effect after single and as-needed repeat administration of the bimatoprost implant in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT). This study is an interim analysis of an ongoing, prospective, open-label, multicenter study in patients with OAG or OHT who are inadequately managed with topical IOP-lowering medication for reasons other than efficacy. IOP-lowering rescue treatment is allowed if implant retreatment criteria are not met. The primary endpoint is time to retreatment/rescue after the initial implant administration analyzed with the Kaplan-Meier method. Key safety measures include treatment-emergent adverse events (TEAEs) and reading-center evaluation of central corneal endothelial cell density (CECD). Analysis of data collected through 15 September 2023 focused on outcomes after a single or two implants. In total, 441 patients received the 10-µg bimatoprost implant in the study eye on day 1 (cycle 1), 179 patients received a second administration (cycle 2), and 378 patients had at least 12 months of follow-up data available. The median time (95% confidence interval) from the first administration to a second administration or rescue was 392 (369, 485) days; the probability of not requiring retreatment or rescue by day 360 was 57.5%. A second implant administration similarly provided a long duration of IOP control. The baseline mean (standard error, SE) IOP was 25.6 (0.14) mmHg; the mean (SE) change from baseline IOP in unrescued eyes after a single administration was - 7.5 (0.21) mmHg at week 24 and - 6.4 (0.28) mmHg at month 12. Conjunctival hyperemia, typically associated with the administration procedure, was the most common ocular TEAE (cycle 1, 14.3%; cycle 2, 12.8%). Mean (SE) percentage change in CECD from baseline at 12 months after administration was - 4.3 (0.81)% in cycle 1 and - 8.5 (2.22)% in cycle 2. The cycle 1 implant was no longer visible or ≤ 25% of initial size in 66.3% and 94.3% of study eyes at months 12 and 24, respectively. In this interim analysis based on available data, the IOP-lowering effect of the initial administration of the 10-µg bimatoprost implant was well maintained for > 1 year in most patients. Results after a second administration were comparable. The safety profile of initial and repeat administration was acceptable. ClinicalTrials.gov identifier NCT03850782; registered 20 February 2019.
Innovative Controllable Torsional Damper Based on Vacuum Packed Particles
In this paper a new concept of a controllable granular damper is presented. The introduced prototype works based on so-called vacuum packed particles (VPPs). Such structures are made of granular materials located in a soft and hermetic encapsulation. As a result of generating a partial vacuum inside the system, the structure starts to behave like a nonclassical solid body. The global physical (mechanical) features of VPPs depend on the level of internal underpressure. The introduced prototype of a controllable torsional damper exhibits various dissipative properties as a function of internal underpressure. The design details of the investigated device are presented. Basic laboratory tests results are discussed. To describe the hysteretic behavior of the device, the Bouc–Wen rheological model has been modified and adopted. Nonlinear functions of underpressure have been introduced to the initial model formulation. The developed Bouc–Wen model has been applied to capture the real response of the VPP torsional damper prototype.
Lichen-Derived Compounds and Extracts as Biologically Active Substances with Anticancer and Neuroprotective Properties
Lichens are a source of chemical compounds with valuable biological properties, structurally predisposed to penetration into the central nervous system (CNS). Hence, our research aimed to examine the biological potential of lipophilic extracts of Parmelia sulcata, Evernia prunastri, Cladonia uncialis, and their major secondary metabolites, in the context of searching for new therapies for CNS diseases, mainly glioblastoma multiforme (GBM). The extracts selected for the study were standardized for their content of salazinic acid, evernic acid, and (−)-usnic acid, respectively. The extracts and lichen metabolites were evaluated in terms of their anti-tumor activity, i.e., cytotoxicity against A-172 and T98G cell lines and anti-IDO1, IDO2, TDO activity, their anti-inflammatory properties exerted by anti-COX-2 and anti-hyaluronidase activity, antioxidant activity, and anti-acetylcholinesterase and anti-butyrylcholinesterase activity. The results of this study indicate that lichen-derived compounds and extracts exert significant cytotoxicity against GBM cells, inhibit the kynurenine pathway enzymes, and have anti-inflammatory properties and weak antioxidant and anti-cholinesterase properties. Moreover, evernic acid and (−)-usnic acid were shown to be able to cross the blood-brain barrier. These results demonstrate that lichen-derived extracts and compounds, especially (−)-usnic acid, can be regarded as prototypes of pharmacologically active compounds within the CNS, especially suitable for the treatment of GBM.
Inflammatory Proteins HMGA2 and PRTN3 as Drivers of Vulvar Squamous Cell Carcinoma Progression
Current knowledge on the biology of squamous cell vulvar carcinoma (VSCC) is limited. We aimed to identify protein markers of VSCC tumors that would permit to stratify patients by progression risk. Early-stage tumors from patients who progressed (progVSCC) and from those who were disease-free (d-fVSCC) during follow-up, along with normal vulvar tissues were examined by mass spectrometry-based proteomics. Differentially expressed proteins (DEPs) were then verified in solid tissues and blood samples of patients with VSCC tumors and vulvar premalignant lesions. In progVSCC vs. d-fVSCC tumors, the immune response was the most over-represented Gene Ontology category for the identified DEPs. Pathway profiling suggested bacterial infections to be linked to aggressive VSCC phenotypes. High Mobility Group AT-Hook 2 (HMGA2) and Proteinase 3 (PRTN3) were revealed as proteins predicting VSCC progression. HMGA2 and PRTN3 abundances are associated with an aggressive phenotype, and hold promise as markers for VSCC patient stratification. It appears that vulvovaginal microflora disturbances trigger an inflammatory response contributing to cancer progression, suggesting that bacterial rather than viral infection status should be considered in the development of targeted therapies in VSCC.