PURPOSE: This study aimed to evaluate one-year clinical outcomes in cataract patients with pre-existing corneal astigmatism implanted with a biconvex aspheric toric monofocal intraocular lens (IOL) with a double C-loop haptic-design. METHODS: One hundred and eighteen patients (236 eyes) with corneal astigmatism (≥0.75D) were implanted bilaterally with the PODEYE toric IOL and assessed up to 1-year after surgery. Postoperative evaluation included monocular and binocular uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA), under both photopic and mesopic lighting conditions, refraction, photopic and mesopic contrast sensitivity (with and without glare), and rotational stability. RESULTS: At the last postoperative visit, 74.6% and 95.8% of eyes were within ±0.50D and ±1.00D of the target refraction, respectively. About 78.0% and 97.5% of eyes showed a postoperative refractive cylinder of ≤0.50D and ≤1.00D, respectively. The mean manifest spherical equivalent value was 0.16±0.40D, and the mean refractive cylinder value was -0.42±0.33D. 97.5% and 100% of patients had a binocular UDVA and CDVA of ≥20/32, respectively. The mean binocular UDVA and CDVA were 0.01±0.09 and -0.03±0.07 logMAR, respectively. Under mesopic conditions, 79.5% and 89.8% of patients showed a binocular UDVA and CDVA of ≥20/32, respectively. The mean binocular UDVA and CDVA were 0.15±0.11 and 0.10±0.10 logMAR, respectively. Binocular contrast sensitivity function both under photopic and mesopic conditions was good. The mean absolute IOL rotation was 2.52±2.59 degrees with 98.56% of eyes having a rotation of less than 10 degrees. CONCLUSION: Bilateral implantation of an aspheric toric monofocal IOL with a double C-loop haptic design in cataract patients with corneal astigmatism provides good visual and refractive outcomes up to 1-year post-surgery.
- Publikační typ
- časopisecké články MeSH
- kazuistiky MeSH
- klinické zkoušky MeSH
PURPOSE: We investigated the safety and efficacy of peroneal electrical transcutaneous neuromodulation using the URIS neuromodulation system in a home-based setting in comparison with standard treatment using solifenacin in treatment-naïve female patients with overactive bladder. MATERIALS AND METHODS: A total of 120 patients were screened, of whom 77 were randomized in a 2:1 ratio to 12 weeks of treatment with daily peroneal electrical transcutaneous neuromodulation or solifenacin 5 mg. The primary endpoint was safety; efficacy assessments included proportion of responders, defined as subjects with ≥50% reduction in bladder diary-derived variables; Overactive Bladder-Validated 8-question Screener, and European Quality of Life-5 Dimensions questionnaire; and treatment satisfaction after 12 weeks of therapy. RESULTS: Seventy-one out of 77 randomized patients completed the study. In the peroneal electrical transcutaneous neuromodulation group 6/51 (12%) patients reported a treatment-related adverse event vs 12/25 (48%) in the solifenacin group (P < .001). No clinically significant changes were observed in any other safety endpoint. The proportions of responders in the peroneal electrical transcutaneous neuromodulation group vs the solifenacin group were 87% vs 74% with respect to Patient Perception of Intensity of Urgency Scale grade 3 urgency episodes, 87% vs 75% with respect to grade 3+4 urgency episodes, and 90% vs 94% with respect to urgency incontinence episodes. In post hoc analyses we observed significant improvement over time in multiple efficacy variables in both treatment arms. CONCLUSIONS: Peroneal electrical transcutaneous neuromodulation is a safe and effective method for overactive bladder treatment associated with a significantly lower incidence of treatment-related adverse events compared to solifenacin and a considerably better benefit-risk profile.
- MeSH
- antagonisté muskarinových receptorů MeSH
- hyperaktivní močový měchýř * farmakoterapie MeSH
- kvalita života MeSH
- lidé MeSH
- prospektivní studie MeSH
- solifenacin sukcinát * terapeutické užití MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
INTRODUCTION AND HYPOTHESIS: The aim of this prospective, open-label, multicenter, noncomparative study was to evaluate the efficacy and safety of peroneal electrical transcutaneous neuromodulation (peroneal eTNM®) using the URIS® neuromodulation system as a home treatment for refractory overactive bladder (OAB). METHODS: The patients were treated with daily peroneal eTNM® for 30 min over a 6-week period. The primary endpoint was defined as the proportion of responders, i.e., participants with ≥ 50% reduction in the average daily sum of severe urgency episodes (defined as "I could not postpone voiding but had to rush to the toilet in order not to wet myself") and urgency incontinence episodes. In addition, bladder diary variables, symptom severity (OAB V8 questionnaire), treatment satisfaction (visual analog scale), and pain perception (visual analog scale) were evaluated at baseline (BL), at week 4 (W4), and at the end of treatment (EoT). Safety evaluations included monitoring of the incidence and severity of adverse events (AEs). Changes in time were analyzed using the nonparametric one-way ANOVA Friedman test for categorical variables and the Wilcoxon rank-sum test for the noncategorical variables. RESULTS: In total, 40 subjects were screened and 29 were included in the full analysis set. The proportion of responders was 86% at W4 and 79% at EoT. There was a significant reduction in frequency (p<0.001), number of severe urgency episodes (p< 0.001), number of urgency incontinence episodes (p=0.001), and number of nocturia episodes (p=0.002). There was a significant improvement in the OAB V8 score and treatment satisfaction (both p<0.001). Two mild treatment-related AEs were recorded. Both patients recovered without sequelae and completed the study. CONCLUSIONS: Peroneal eTNM® proved to be a highly effective and safe method for the home treatment of OAB, providing a therapeutic response in approximately 80% of patients.
- MeSH
- hyperaktivní močový měchýř * farmakoterapie MeSH
- inkontinence moči * MeSH
- lidé MeSH
- močení fyziologie MeSH
- prospektivní studie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
Overactive bladder syndrome (OAB) is a prevalent medical problem with a significant impact on the quality of life of the affected individuals. Pharmacotherapy is considered the main treatment method, although it is discontinued in a significant proportion of patients due to inefficacy or associated side effects. If pharmacotherapy fails, patients can undergo peripheral neuromodulation of the somatic nerves of the lower limb or sacral neuromodulation; however, neither of these represents an ideal therapeutic tool. The Peroneal electric Transcutaneous NeuroModulation (Peroneal eTNM®), based on the selective stimulation of the peroneal nerve, is the new fully noninvasive neuromodulation method intended to treat OAB. The URIS® neuromodulation system, engineered to provide Peroneal eTNM®, consists of the URIS® device, URIS® active electrodes, and the biofeedback foot sensor (BFS). The unique design of the URIS® device and URIS® active electrodes allows for the use of a low voltage and current during neuromodulation, which significantly reduces the unpleasant sensations. The BFS allows for precise localization of the active electrodes and for continuous adjustment of the voltage and frequency to achieve the optimal therapeutic effect. The URIS® system adopts several principles of telemedicine, which makes it compatible with the US Food and Drug Administration (FDA) and European Union (EU) regulations for home-based use. This article describes both the Peroneal eTNM® method and the URIS® neuromodulation system, including its technical specifications and data from laboratory testing. Preclinical and early clinical data demonstrate the feasibility of this new method for noninvasive OAB treatment and possible implications for clinical practice.
- MeSH
- elektrody MeSH
- elektrostimulační terapie * MeSH
- hyperaktivní močový měchýř * terapie MeSH
- kvalita života MeSH
- lidé MeSH
- telemedicína * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Spojené státy americké MeSH
PURPOSE: To evaluate the efficacy of epithelium-on photorefractive intrastromal crosslinking (PiXL), a noninvasive procedure to reduce refractive error in patients with low hyperopia. SETTING: Gemini Eye Clinic, Zlin, Czech Republic. DESIGN: Prospective single-center study. METHODS: Twenty-two low hyperopic eyes were enrolled and underwent PiXL treatment according to a standardized treatment protocol. Visual acuity, subjective distance refraction, keratometry, topography, pachymetry, subjective discomfort, and endothelial cell density (ECD) were recorded during 12-month follow-up. RESULTS: In 22 eyes, the median manifest refraction decreased significantly (P < .0001) from +0.75 diopters (D) (interquartile range [IQR], +0.63 to +1.06 D), median and IQR) diopters (D) preoperatively to +0.25 D (IQR, 0.0 to +0.50 D) at 12-month follow-up and remained stable. Seventy-seven percent of eyes achieved refraction within ± 0.50 D of emmetropia by 1 month postoperatively and was stable through 12-month follow-up. ECD was stable and did not show significant changes. There was low incidence of postoperative pain and dry eye. CONCLUSIONS: PiXL is a promising alternative to conventional laser refractive surgeries for low hyperopia. Further studies are warranted to optimize treatment parameters for a wider range of refractive errors and to evaluate the potential to improve precision.
- MeSH
- fotochemoterapie metody MeSH
- fotosenzibilizující látky terapeutické užití MeSH
- hypermetropie farmakoterapie metabolismus patofyziologie MeSH
- kolagen metabolismus MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- pachymetrie rohovky MeSH
- pilotní projekty MeSH
- prospektivní studie MeSH
- reagencia zkříženě vázaná * MeSH
- refrakce oka fyziologie MeSH
- riboflavin terapeutické užití MeSH
- senioři MeSH
- stroma rohovky účinky léků metabolismus MeSH
- ultrafialové záření MeSH
- výsledek terapie MeSH
- zraková ostrost fyziologie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
PURPOSE: To report the initial experience with a new presbyopic phakic intraocular lens (pIOL) in the correction of high myopia and presbyopia. SETTING: Gemini Eye Clinic, Zlin, Czech Republic. DESIGN: Prospective cohort study. METHODS: Presbyopic eyes with moderate to high myopia were implanted with a presbyopic posterior chamber pIOL (IPCL). The visual acuities at near and distance, endothelial cell density, and ocular condition were examined 1 week, 3 months, 1 year and 2 years postoperatively. RESULTS: The mean uncorrected distance visual acuity improved significantly from 1.25 logarithm of the minimum angle of resolution (logMAR) (1.15 to 1.35 95% confidence interval [CI]) to 0.11 logMAR (95% CI, 0.03 to 0.17) (P < .0001). No eye lost 1 or more lines of corrected distance visual acuity. The mean distance refraction improved significantly from -6.9 diopters (D) (range -8.6 to -5.3 D) preoperatively to -0.35 D (range -0.55 to -0.15 D, P < .0001) with less than -0.5 D residual refraction in 11 of 17 eyes. Fifteen of 17 eyes had improved uncorrected near visual acuity to J1 (Jaeger chart) at the 2-year follow-up. The near addition at the 2-year follow-up decreased from preoperatively +1.26 D (range 0.19 to 2.34 D) to +0.39 D (range 0.18 to 0.60 D). The mean endothelial cell density was reduced from 2552 cells/mm (range 2421 to 2682 cells/mm) to 2299 cells/mm (range 2108 to 2490 cells/mm) after 2 years. All patients were subjectively satisfied with the outcomes. CONCLUSIONS: The new pIOL provided good visual outcomes in near and far distances in an initial case series of patients.
- MeSH
- degenerativní myopie patofyziologie chirurgie MeSH
- dospělí MeSH
- fakické nitrooční čočky * MeSH
- implantace nitrooční čočky * MeSH
- lidé středního věku MeSH
- lidé MeSH
- nitrooční tlak fyziologie MeSH
- presbyopie patofyziologie chirurgie MeSH
- prospektivní studie MeSH
- refrakce oka fyziologie MeSH
- zraková ostrost fyziologie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
Cíl: Klinické výsledky zadní lamelární transplantace Descemetské membrány s endotelem (DMEK) novou metodou oddělení dárcovské Descemetské membrány (DM) hydroseparací v 6 měsíční sledovací době. Materiály a metody: Retrospektivní studie jednoho centra a chirurga u 16 očí po sobě jdoucích pacientů, kteří podstoupili DMEK anebo DMEK kombinovaný s operací katarakty se separací membrány dárce kapalinou. K oddělení DM dárcovské rohovky byl použit Ringerův roztok vstříknutý pod tlakem mezi DM a rohovkové stroma pomocí tupé jehly. Hustota buněk endotelu, korigovaná a nekorigovaná zraková ostrost (CDVA, UDVA) a topografie rohovky K2, K1 se vyhodnotila před a šest měsíců po transplantaci. Výsledky: DM s endotelem pro DMEK se úspěšně a bez roztržení oddělila z rohovky dárce ve všech případech a u všech pacientů došlo k její adhezi k rohovce příjemce. Celkově se korigovaná zraková ostrost do dálky CDVA zlepšila signifikantně (p < 0,0001) z 0,69 logMAR (0,45–0,92, 95% CI) na 0,1 logMAR (0,04–0,15). Nekorigovaná zraková ostrost do dálky UDVA byla horší u pacientů po kombinované operaci katarakty a DMEK po šesti měsících 0,38 logMAR (0,18–0,43) v porovnání s 0,3 logMAR (0,14–0,61) u pacientů po DMEK. U rohovkového astigmatismu došlo k signifikantnímu zlepšení K2-K1 (p = 0,0137) z předoperačního průměru všech očí 2,89 D (0,19–0,43) na 0,98 D (0,48–1,48) za 6 měsíců po operaci. Závěr: Hydroseparace je efektivní a rychlou metodou oddělení dárcovského štěpu pro DMEK. DMEK pomocí hydroseparace štepu dárce zlepšuje zrakovou ostrost a produkuje pouze malou hodnotu astigmatismu šest měsíců po operaci. Další klinické studie jsou potřeba k potvrzení úspěšnosti této metody a v případě kombinované operace s kataraktou k optimalizaci kalkulace optické mohutnosti nitroočních čoček.
Aim: To evaluate clinical outcomes of Descemet Membrane Endothelial Keratoplasty (DMEK) using a novel hydro-separation of donor Descemet membrane (DM) endothelial graft with 6 months follow up. Material and methods: In this retrospective single-center; single surgeon cohort study, 16 consecutive eyes underwent DMEK or combined DMEK and cataract surgery with DMEK donor graft hydro-separation. The hydro- Stodůlka P.1,2, Horáčková M.1, Šramka M.1,3, Slovák M.1 1Gemini oční klinika, Zlín, Česká republika; 2Oftalmologická klinika, 3. lékařské fakulty, Univerzita Karlova v Praze; 3Katedra teorie obvodů, Fakulta elektrotechnická, České vysoké učení technické v Praze Prohlášení: První autor je konzultantem pro Bausch and Lomb. Autoři práce prohlašují, že vznik i téma odborného sdělení a jeho zveřejnění není ve střetu zájmů a není podpořeno žádnou farmaceutickou firmou. Pavel Stodůlka, prim. MUDr., Ph.D., FEBOS-CR Gemini oční klinika, U Gemini 360, 760 01 Zlín, Česká republika e-mail: stodulka@lasik.cz Do redakce doručeno dne: 20. 7. 2018 Do tisku přijato dne: 4. 2. 2019 proLékaře.cz | 7.8.2019 ČESKÁ A SLOVENSKÁ OFTALMOLOGIE 1/2019 33 separation method used Ringer’s solution injected by a syringe with a flat end cannula between DM and corneal stroma to separate DMEK graft from donors’ cornea. Endothelial cell count, corrected and uncorrected distance visual acuities (CDVA, UDVA), corneal astigmatism and keratometric values were evaluated before and 6 months after the surgery Results: DMEK grafts were successfully hydro separated, without a membrane tear in all cases and successful adhesion to recipient corneas was achieved in all cases. Overall CDVA improved significantly (p < 0.0001) from preop. logMAR 0.69 (0.45–0.92, 95%CI) to logMAR 0.1 (0.04–0.15) 6 months postop. However UDVA was slightly worse in cataract combined cases 0.38 logMAR (0.18–0.43) vs 0.3 logMAR (0.14–0.61) in DMEK cases at 6 months. Corneal astigmatism K2-K1 improved significantly (p=0.0137) from preop. mean 2.89 D (0.19–0.43) to 0.98 D (0.48–1.48) 6 months postop. Conclusion: Hydro-separation is fast and effective donor graft preparation method for DMEK. The DMEK using donor graft hydro-separation results in improved vision and induces a low amount of astigmatism at 6 months follow up. Further clinical data are needed to confirm the success rate and to explore optimization of the selection of IOLs in combined cataract cases.
- Klíčová slova
- DMEK, hydroseparace,
- MeSH
- Descemetova membrána chirurgie MeSH
- lidé středního věku MeSH
- lidé MeSH
- retrospektivní studie MeSH
- rohovkový endotel MeSH
- senioři MeSH
- transplantace rohovky * metody MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
Aim: To evaluate the potential of the Support Vector Machine Regression model (SVM-RM) and Multilayer Neural Network Ensemble model (MLNN-EM) to improve the intraocular lens (IOL) power calculation for clinical workflow. Background: Current IOL power calculation methods are limited in their accuracy with the possibility of decreased accuracy especially in eyes with an unusual ocular dimension. In case of an improperly calculated power of the IOL in cataract or refractive lens replacement surgery there is a risk of re-operation or further refractive correction. This may create potential complications and discomfort for the patient. Methods: A dataset containing information about 2,194 eyes was obtained using data mining process from the Electronic Health Record (EHR) system database of the Gemini Eye Clinic. The dataset was optimized and split into the selection set (used in the design for models and training), and the verification set (used in the evaluation). The set of mean prediction errors (PEs) and the distribution of predicted refractive errors were evaluated for both models and clinical results (CR). Results: Both models performed significantly better for the majority of the evaluated parameters compared with the CR. There was no significant difference between both evaluated models. In the ±0.50 D PE category both SVM-RM and MLNN-EM were slightly better than the Barrett Universal II formula, which is often presented as the most accurate calculation formula. Conclusion: In comparison to the current clinical method, both SVM-RM and MLNN-EM have achieved significantly better results in IOL calculations and therefore have a strong potential to improve clinical cataract refractive outcomes.
- Publikační typ
- časopisecké články MeSH
- MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- poruchy sociálního chování MeSH
- primární prevence MeSH
- průzkumy a dotazníky * MeSH
- rizikové faktory MeSH
- senioři MeSH
- sluchově postižení * MeSH
- statistika jako téma MeSH
- výchova dítěte MeSH
- výuka sluchově postižených MeSH
- zákonodárství jako téma MeSH
- znalosti MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- senioři MeSH