المؤلفون: Roszkowska, Anna Maria, Lombardo, Giuseppe, Mencucci, Rita, Scorcia, Vincenzo, Giannaccare, Giuseppe, Vestri, Annarita, Alunni Fegatelli, Danilo, Bernava, Giuseppe Massimo, Serrao, Sebastiano, Lombardo, Marco

المساهمون: Roszkowska, Anna Maria, Lombardo, Giuseppe, Mencucci, Rita, Scorcia, Vincenzo, Giannaccare, Giuseppe, Vestri, Annarita, Alunni Fegatelli, Danilo, Bernava, Giuseppe Massimo, Serrao, Sebastiano, Lombardo, Marco

مصطلحات موضوعية: corneal cross-linking, keratoconu, ribofravin, theranostics

الوصف: The Assessment of theranostic guided riboflavin/UV-A corneal cross-linking for treatment of keratoconus (ARGO; registration number NCT05457647) clinical trial tests the hypothesis that theranostic-guided riboflavin/UV-A corneal cross-linking (CXL) can provide predictable clinical efficacy for halting keratoconus progression, regardless of treatment protocol, i.e., either with or without epithelial removal. Theranostics is an emerging therapeutic paradigm of personalized and precision medicine that enables real-time monitoring of image-guided therapy. In this trial, the theranostic software module of a novel UV-A medical device will be validated in order to confirm its accuracy in estimating corneal cross-linking efficacy in real time. During CXL procedure, the theranostic UV-A medical device will provide the operator with an imaging biomarker, i.e., the theranostic score, which is calculated by non-invasive measurement of corneal riboflavin concentration and its UV-A light mediated photo-degradation. ARGO is a randomized multicenter clinical trial in patients aged between 18 and 40 years with progressive keratoconus aiming to validate the theranostic score by assessing the change of the maximum keratometry point value at 1-year postoperatively. A total of 50 participants will be stratified with allocation ratio 1:1 using a computer-generated stratification plan with blocks in two treatment protocols, such as epithelium-off or epithelium-on CXL. Following treatment, participants will be monitored for 12 months. Assessment of safety and performance of theranostic-guided corneal cross-linking treatment modality will be determined objectively by corneal tomography, corneal endothelial microscopy, visual acuity testing and slit-lamp eye examination.

العلاقة: info:eu-repo/semantics/altIdentifier/pmid/36587174; info:eu-repo/semantics/altIdentifier/wos/WOS:000906309400001; volume:43; issue:7; firstpage:2315; lastpage:2328; numberofpages:14; journal:INTERNATIONAL OPHTHALMOLOGY; https://hdl.handle.net/11573/1700332Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85145335175

الإتاحة: https://doi.org/10.1007/s10792-022-02628-4Test
https://hdl.handle.net/11573/1700332Test

المؤلفون: Lombardo, Marco, Serrao, Sebastiano, Bernava, Giuseppe Massimo, Lombardo, Giuseppe

المصدر: Journal of Biophotonics; Jul2024, Vol. 17 Issue 7, p1-9, 9p

مستخلص: Seven human donor eye globes underwent corneal cross‐linking using theranostic UV‐A device with accessory corneal iontophoresis system for patterned delivery of a 0.22% riboflavin solution. Theranostic‐guided UV‐A light illumination assessed riboflavin distribution and treated corneas at 10 mW/cm2 for 9 min with a 5.0‐mm beam size. Corneal topography maps were taken at baseline and 2‐h post‐treatment. Analysis utilized corneal topography elevation data, with results showing controlled riboflavin delivery led to a consistent gradient, with 40% higher levels centrally (248 ± 79 μg/cm3) than peripherally (180 ± 72 μg/cm3 at ±2.5 mm from the center). Theranostic‐guided UV‐A light irradiation resulted in significant changes in corneal topography, with a decrease in best‐fit sphere value (−0.7 ± 0.2 D; p < 0.001) and consistent downward shift in corneal elevation map (−11.7 ± 3.7 μm). The coefficient of variation was 2.5%, indicating high procedure performance in achieving significant and reliable corneal flattening. [ABSTRACT FROM AUTHOR]

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المؤلفون: Lombardo, Marco, Alunni Fegatelli, Danilo, Serrao, Sebastiano, Vestri, Annarita, Lombardo, Giuseppe

المصدر: European Journal of Ophthalmology; May2024, Vol. 34 Issue 3, p649-655, 7p

المؤلفون: Lombardo, Giuseppe, Alunni-Fegatelli, Danilo, Serrao, Sebastiano, Mencucci, Rita, Roszkowska, Anna Maria, Bernava, Giuseppe Massimo, Vestri, Annarita, Aleo, Danilo, Lombardo, Marco

المساهمون: Lombardo, Giuseppe, Alunni-Fegatelli, Danilo, Serrao, Sebastiano, Mencucci, Rita, Roszkowska, Anna Maria, Bernava, Giuseppe Massimo, Vestri, Annarita, Aleo, Danilo, Lombardo, Marco

مصطلحات موضوعية: keratoconu, biomechanic, corvis st, mean corneal stiffness parameter, cbi

الوصف: Purpose: The aim of this study was to assess accuracy of the mean corneal stiffness ( kc , N/m) parameter to discriminate between patients with keratoconus and age-matched healthy subjects. Methods: Dynamic Scheimpflug imaging tonometry was performed with Corvis ST (Oculus Optikgeräte GmbH, Germany) in patients with keratoconus (n = 24; study group) and age-matched healthy subjects (n = 32; control). An image processing algorithm was developed to analyze the video sequence of the Corvis ST air-puff event and to determine the geometric and temporal parameters that correlated with the corneal tissue biomechanical properties. A modified 3-element viscoelastic model was used to derive the kc parameter, which represented the corneal tissue resistance to deformation under load. Receiver operating characteristic curves were used to assess the overall diagnostic performance for determining the area under the curve, sensitivity, and specificity of the kc in assessing the corneal tissue deformation to the Corvis ST air-puff event in keratoconus and control eyes. The Corvis Biomechanical Index ( CBI ) was analyzed for external validation. Results: The kc parameter was significantly different between keratoconus and controls ( P < 0.001), ranging from 24.9 ±3.0 to 34.2 ±3.5 N/m, respectively. It was highly correlated with CBI (r = -0.69; P < 0.001); however, the kc parameter had greater specificity (94%) than CBI (75%), whereas the 2 biomarkers had similar area under the curve (0.98 vs. 0.94) and sensitivity (96% vs. 92%) in predicting the occurrence of keratoconus. Conclusions: The kc parameter extracted by video processing analysis of dynamic Scheimpflug tonometry data was highly accurate in discriminating patients with clinically manifest keratoconus compared with controls.

العلاقة: info:eu-repo/semantics/altIdentifier/pmid/37964435; info:eu-repo/semantics/altIdentifier/wos/WOS:001157871600008; volume:43; issue:3; firstpage:315; lastpage:322; numberofpages:8; journal:CORNEA; https://hdl.handle.net/11573/1701147Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85184291197

الإتاحة: https://doi.org/10.1097/ICO.0000000000003377Test
https://hdl.handle.net/11573/1701147Test

المؤلفون: Lombardo, Giuseppe, Bernava, Giuseppe Massimo, Serrao, Sebastiano, Lombardo, Marco

المساهمون: Lazio Innova

المصدر: Journal of Biophotonics ; volume 15, issue 12 ; ISSN 1864-063X 1864-0648

الوصف: Theranostics is an emerging therapeutic paradigm of personalized medicine; the term refers to the simultaneous integration of therapy and diagnostics. In this work, theranostic‐guided corneal cross‐linking was performed on 10 human sclero‐corneal tissues. The samples were soaked with 0.22% riboflavin formulation and underwent 9 minutes UV‐A irradiance at 10 mW/cm 2 using theranostic device, which provided both a measure of corneal riboflavin concentration and a theranostic score estimating treatment efficacy in real time. A three‐element viscoelastic model was developed to fit the deformation response of the cornea to air‐puff excitation of dynamic tonometry and to calculate the mean corneal stiffness parameter before and after treatment. Significant correlation was found between the theranostic score and the increase in mean corneal stiffness (R = 0.80; P < .001). Accuracy and precision of the theranostic score in predicting the induced corneal tissue stiffening were both 90%. The riboflavin concentration prior to starting the UV‐A photo‐therapy phase was the most important variable to allow corneal cross‐linking to be effective. Theranostic UV‐A light mediated imaging and therapy enables the operator to adopt a precise approach for achieving highly predictable biomechanical strengthening on individual corneas.

الإتاحة: https://doi.org/10.1002/jbio.202200218Test

المؤلفون: Roszkowska, Anna Maria, Lombardo, Giuseppe, Mencucci, Rita, Scorcia, Vincenzo, Giannaccare, Giuseppe, Vestri, Annarita, Alunni Fegatelli, Danilo, Bernava, Giuseppe Massimo, Serrao, Sebastiano, Lombardo, Marco

المصدر: International Ophthalmology ; volume 43, issue 7, page 2315-2328 ; ISSN 1573-2630

مصطلحات موضوعية: Ophthalmology

الوصف: The Assessment of theranostic guided riboflavin/UV-A corneal cross-linking for treatment of keratoconus (ARGO; registration number NCT05457647) clinical trial tests the hypothesis that theranostic-guided riboflavin/UV-A corneal cross-linking (CXL) can provide predictable clinical efficacy for halting keratoconus progression, regardless of treatment protocol, i.e., either with or without epithelial removal. Theranostics is an emerging therapeutic paradigm of personalized and precision medicine that enables real-time monitoring of image-guided therapy. In this trial, the theranostic software module of a novel UV-A medical device will be validated in order to confirm its accuracy in estimating corneal cross-linking efficacy in real time. During CXL procedure, the theranostic UV-A medical device will provide the operator with an imaging biomarker, i.e., the theranostic score, which is calculated by non-invasive measurement of corneal riboflavin concentration and its UV-A light mediated photo-degradation. ARGO is a randomized multicenter clinical trial in patients aged between 18 and 40 years with progressive keratoconus aiming to validate the theranostic score by assessing the change of the maximum keratometry point value at 1-year postoperatively. A total of 50 participants will be stratified with allocation ratio 1:1 using a computer-generated stratification plan with blocks in two treatment protocols, such as epithelium-off or epithelium-on CXL. Following treatment, participants will be monitored for 12 months. Assessment of safety and performance of theranostic-guided corneal cross-linking treatment modality will be determined objectively by corneal tomography, corneal endothelial microscopy, visual acuity testing and slit-lamp eye examination.

الإتاحة: https://doi.org/10.1007/s10792-022-02628-4Test

المؤلفون: Lombardo, Marco, Serrao, Sebastiano, Lombardo, Giuseppe

المصدر: Frontiers in Medicine ; volume 9 ; ISSN 2296-858X

مصطلحات موضوعية: General Medicine

الوصف: Age-related macular degeneration (AMD) is a chronic multifactorial eye disease representing the primary cause of vision loss in people aged 60 years and older. The etiopathogenesis of the disease remains uncertain, with several risk factors contributing to its onset and progression, such as genotype, aging, hypertension, smoking, overweight, and low dietary intake of carotenoids. Since the aging populations of the industrialized world are increasing rapidly, the impact of AMD in the socio-economical life-developed countries is expected to increase dramatically in the next years. In this context, the benefits of prevention and early disease detection for prompt and effective treatment can be enormous to reduce the social and economic burden of AMD. Nutritional and lifestyle changes, including dietary intake of xanthophyll pigments, such as lutein and zeaxanthin, no smoking, and regular exercise, are known to protect from risk of AMD progression from early to advanced disease stages. In this review, we present the clinical outcomes of a pilot study on trans-scleral iontophoresis delivery of lutein in patients with AMD. Topical delivery of lutein directly to the macula may provide a more efficient method for enriching the macular pigment and for achieving greater patient compliance to therapy than oral administration and thus enhancing prevention strategies. Modern diagnostic methodologies shall address the major problem of accurately detecting the risk of transition from intermediate AMD to advanced AMD stages. Adaptive optics retinal imaging and resonance Raman spectroscopy are two highly promising technologies for the objective assessment of patients with AMD. In this review, we present some of their clinical applications for collecting quantitative measurements of retinal cellular changes and macular content of xanthophyll pigments, respectively. In conclusion, there is great expectation that technological advancements in AMD management will deliver improved screening, therapeutic prevention, and diagnostic ...

الإتاحة: https://doi.org/10.3389/fmed.2022.887104Test

المؤلفون: Lombardo, Marco, Bernava, Giuseppe Massimo, Serrao, Sebastiano, Roszkowska, Anna Maria, Lombardo, Giuseppe

المساهمون: Lombardo, Marco, Bernava, Giuseppe Massimo, Serrao, Sebastiano, Roszkowska, Anna Maria, Lombardo, Giuseppe

الوصف: Purpose: To assess predictability of tissue biomechanical stiffening induced by UV-A light mediated real-time assessment of riboflavin concentration during corneal cross-linking (CXL) of human donor tissues. Setting: Studio Italiano di Oftalmologia, Italy. Design: Laboratory study. Methods: Twenty sclero-corneal tissues were randomly stratified to undergo CXL with either the epithelium intact (n=12) or removed (n=8). Samples underwent corneal soaking with 0.22% riboflavin formulation (RitSight, Regensight srl) with dosing time of t=10 minutes and t=20 minutes in Epi-Off and Epi-On protocols respectively. All tissues underwent 9 minutes UV-A irradiance at 10 mW/cm2 using theranostic device (C4V CHROMO4VIS, Regensight srl). The device utilized controlled UV-A light irradiation to induce both imaging and treatment of the cornea, providing a real time measure of corneal riboflavin concentration and treatment efficacy (i.e., theranostic score) during surgery. Tissue biomechanics was assessed with air-puff device (Corvis, Oculus Optikgeräte GmbH), which was performed before and after treatment. A three-element viscoelastic model was developed to fit the corneal deformation response to air-puff excitation and to calculate the mean corneal stiffness parameter (kc). Results: Significant corneal tissue stiffening (P<0.05) was induced by theranostic UV-A device in either CXL treatment protocol. Significant correlation was found between the theranostic score and the increase in kc (R=0.75; P=0.003). The score showed high accuracy (94%) and precision (94%) to predict correctly samples that had improved tissue biomechanical strengthening. Conclusion: Real-time assessment of corneal riboflavin concentration provided a predictive and precise approach for significant improvement of tissue strength on individual corneas, regardless of CXL treatment protocol.

العلاقة: info:eu-repo/semantics/altIdentifier/pmid/36745847; info:eu-repo/semantics/altIdentifier/wos/WOS:001076766500016; volume:Publish Ahead of Print; firstpage:1; lastpage:10; numberofpages:10; journal:JOURNAL OF CATARACT AND REFRACTIVE SURGERY; https://hdl.handle.net/11570/3253416Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85160966245

الإتاحة: https://doi.org/10.1097/j.jcrs.0000000000001163Test
https://hdl.handle.net/11570/3253416Test

المؤلفون: Lombardo, Giuseppe, Alunni-Fegatelli, Danilo, Serrao, Sebastiano, Mencucci, Rita, Roszkowska, Anna Maria, Bernava, Giuseppe Massimo, Vestri, Annarita, Aleo, Danilo, Lombardo, Marco

المصدر: Cornea ; volume 43, issue 3, page 315-322 ; ISSN 0277-3740

الوصف: Purpose: The aim of this study was to assess accuracy of the mean corneal stiffness ( k c , N/m) parameter to discriminate between patients with keratoconus and age-matched healthy subjects. Methods: Dynamic Scheimpflug imaging tonometry was performed with Corvis ST (Oculus Optikgeräte GmbH, Germany) in patients with keratoconus (n = 24; study group) and age-matched healthy subjects (n = 32; control). An image processing algorithm was developed to analyze the video sequence of the Corvis ST air-puff event and to determine the geometric and temporal parameters that correlated with the corneal tissue biomechanical properties. A modified 3-element viscoelastic model was used to derive the k c parameter, which represented the corneal tissue resistance to deformation under load. Receiver operating characteristic curves were used to assess the overall diagnostic performance for determining the area under the curve, sensitivity, and specificity of the k c in assessing the corneal tissue deformation to the Corvis ST air-puff event in keratoconus and control eyes. The Corvis Biomechanical Index ( CBI ) was analyzed for external validation. Results: The k c parameter was significantly different between keratoconus and controls ( P < 0.001), ranging from 24.9 ±3.0 to 34.2 ±3.5 N/m, respectively. It was highly correlated with CBI (r = −0.69; P < 0.001); however, the k c parameter had greater specificity (94%) than CBI (75%), whereas the 2 biomarkers had similar area under the curve (0.98 vs. 0.94) and sensitivity (96% vs. 92%) in predicting the occurrence of keratoconus. Conclusions: The k c parameter extracted by video processing analysis of dynamic Scheimpflug tonometry data was highly accurate in discriminating patients with clinically manifest keratoconus compared with controls.

الإتاحة: https://doi.org/10.1097/ico.0000000000003377Test

المؤلفون: Serrao, Sebastiano, Lombardo, Marco

المصدر: American Journal of Ophthalmology Case Reports ; volume 14, page 32-34 ; ISSN 2451-9936

مصطلحات موضوعية: Ophthalmology

الإتاحة: https://doi.org/10.1016/j.ajoc.2019.02.002Test
https://api.elsevier.com/content/article/PII:S2451993617303067?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S2451993617303067?httpAccept=text/plainTest