Pub Date : 2025-01-01Epub Date: 2024-11-30DOI: 10.1007/s40123-024-01073-z
J Morgan Micheletti, Mitchell Shultz, Inder Paul Singh, Thomas W Samuelson
The glaucoma treatment paradigm is in evolution. The topical medications-first approach is limited by significant barriers such as high rates of nonadherence and side effects including ocular surface disease. The era of interventional glaucoma has seen the development of selective laser trabeculoplasty (SLT), procedural pharmaceuticals, and minimally invasive glaucoma surgeries (MIGS). New and emerging data support the use of these interventional treatment modalities early in the course of glaucoma rather than reserving them for advanced or treatment-recalcitrant cases. The various treatments available represent multiple mechanisms (e.g., trabecular outflow, uveoscleral outflow, aqueous suppression) and modalities (medications, laser, incisional surgery) by which intraocular pressure (IOP) is reduced. Many patients require more than one treatment to achieve adequate IOP reduction and glaucoma control. Comprehensive IOP control-reduction of both mean IOP and IOP fluctuation-can best be achieved by targeting multiple mechanisms of IOP reduction and taking advantage of the attributes of multiple treatment modalities.
{"title":"An Emerging Multi-mechanism and Multi-modal Approach in Interventional Glaucoma Therapy.","authors":"J Morgan Micheletti, Mitchell Shultz, Inder Paul Singh, Thomas W Samuelson","doi":"10.1007/s40123-024-01073-z","DOIUrl":"10.1007/s40123-024-01073-z","url":null,"abstract":"<p><p>The glaucoma treatment paradigm is in evolution. The topical medications-first approach is limited by significant barriers such as high rates of nonadherence and side effects including ocular surface disease. The era of interventional glaucoma has seen the development of selective laser trabeculoplasty (SLT), procedural pharmaceuticals, and minimally invasive glaucoma surgeries (MIGS). New and emerging data support the use of these interventional treatment modalities early in the course of glaucoma rather than reserving them for advanced or treatment-recalcitrant cases. The various treatments available represent multiple mechanisms (e.g., trabecular outflow, uveoscleral outflow, aqueous suppression) and modalities (medications, laser, incisional surgery) by which intraocular pressure (IOP) is reduced. Many patients require more than one treatment to achieve adequate IOP reduction and glaucoma control. Comprehensive IOP control-reduction of both mean IOP and IOP fluctuation-can best be achieved by targeting multiple mechanisms of IOP reduction and taking advantage of the attributes of multiple treatment modalities.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"13-22"},"PeriodicalIF":2.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724811/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142771029","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-12-14DOI: 10.1007/s40123-024-01061-3
Anat Loewenstein, Michelle Sylvanowicz, Winfried M Amoaku, Tariq Aslam, Chui Ming Gemmy Cheung, Bora Eldem, Robert P Finger, Richard P Gale, Laurent Kodjikian, Adrian Koh, Jean-François Korobelnik, Xiaofeng Lin, Paul Mitchell, Moira Murphy, Mali Okada, Ian Pearce, Francisco J Rodriguez, Jude Stern, S James Talks, David T Wong, Tien Yin Wong, Focke Ziemssen, Jane Barratt
Introduction: Neovascular age-related macular degeneration is a global public-health concern, associated with a considerable burden to individuals, healthcare systems, and society. The objective of this study was to understand different perspectives on the challenges associated with the clinical management of neovascular age-related macular degeneration, which could elucidate measures to comprehensively improve clinical care and outcomes.
Methods: A survey was carried out of patients with neovascular age-related macular degeneration, their providers, and clinic staff in 77 clinics across 24 countries on six continents, from a diverse range of healthcare systems, settings, and reimbursement models. Surveys comprised a series of single/multiple-response questions completed anonymously. Data gathered included patient personal characteristics, appointment attendance challenges, treatment experiences, and opportunities to improve support. Provider and clinic staff surveys asked similar questions about their perspectives; clinic characteristics were also captured.
Results: There were 6425 responses; 4558 patients with neovascular age-related macular degeneration, 659 providers, and 1208 clinic staff. Challenges identified included concern about patient burden to family/friends, high frequency of treatment, difficulties in traveling to appointments, long waiting times, and insufficient comprehension of neovascular age-related macular degeneration. Participants identified logistical (improved financial assistance with treatment and out-of-pocket costs, and appointment reminders), operational (addressing clinic set up to reduce waiting times and improving the amount of time providers spend with patients), and educational (improving quality and provision of patient information and expectation-setting) opportunities to improve care.
Conclusions: The wealth of data generated by this global survey highlights the breadth of challenges associated with clinical management of patients with neovascular age-related macular degeneration. Addressing the opportunities raised could improve patient adherence to treatment and potentially outcomes, reduce appointment burden, and increase clinic capacity.
{"title":"Global Insights from Patients, Providers, and Staff on Challenges and Solutions in Managing Neovascular Age-Related Macular Degeneration.","authors":"Anat Loewenstein, Michelle Sylvanowicz, Winfried M Amoaku, Tariq Aslam, Chui Ming Gemmy Cheung, Bora Eldem, Robert P Finger, Richard P Gale, Laurent Kodjikian, Adrian Koh, Jean-François Korobelnik, Xiaofeng Lin, Paul Mitchell, Moira Murphy, Mali Okada, Ian Pearce, Francisco J Rodriguez, Jude Stern, S James Talks, David T Wong, Tien Yin Wong, Focke Ziemssen, Jane Barratt","doi":"10.1007/s40123-024-01061-3","DOIUrl":"10.1007/s40123-024-01061-3","url":null,"abstract":"<p><strong>Introduction: </strong>Neovascular age-related macular degeneration is a global public-health concern, associated with a considerable burden to individuals, healthcare systems, and society. The objective of this study was to understand different perspectives on the challenges associated with the clinical management of neovascular age-related macular degeneration, which could elucidate measures to comprehensively improve clinical care and outcomes.</p><p><strong>Methods: </strong>A survey was carried out of patients with neovascular age-related macular degeneration, their providers, and clinic staff in 77 clinics across 24 countries on six continents, from a diverse range of healthcare systems, settings, and reimbursement models. Surveys comprised a series of single/multiple-response questions completed anonymously. Data gathered included patient personal characteristics, appointment attendance challenges, treatment experiences, and opportunities to improve support. Provider and clinic staff surveys asked similar questions about their perspectives; clinic characteristics were also captured.</p><p><strong>Results: </strong>There were 6425 responses; 4558 patients with neovascular age-related macular degeneration, 659 providers, and 1208 clinic staff. Challenges identified included concern about patient burden to family/friends, high frequency of treatment, difficulties in traveling to appointments, long waiting times, and insufficient comprehension of neovascular age-related macular degeneration. Participants identified logistical (improved financial assistance with treatment and out-of-pocket costs, and appointment reminders), operational (addressing clinic set up to reduce waiting times and improving the amount of time providers spend with patients), and educational (improving quality and provision of patient information and expectation-setting) opportunities to improve care.</p><p><strong>Conclusions: </strong>The wealth of data generated by this global survey highlights the breadth of challenges associated with clinical management of patients with neovascular age-related macular degeneration. Addressing the opportunities raised could improve patient adherence to treatment and potentially outcomes, reduce appointment burden, and increase clinic capacity.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"211-228"},"PeriodicalIF":2.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724828/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142822462","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-11-02DOI: 10.1007/s40123-024-01050-6
Raul E Ruiz-Lozano, Monica I Herrera-Rodriguez, Jazmin A Mendoza-Pallares, Natalia Reyes-Godinez, Veronica E Tamez-Tamez, Eugenia M Ramos-Dávila, Luis G Villagomez-Valdez, Lucas A Garza-Garza, Manuel E Quiroga-Garza, Ali Khodor, Jose J Gongora-Cortes, Alejandro Rodriguez-Garcia
Introduction: The needs of family caregivers providing care to relatives with visual impairment are often dismissed, leading to caregiver burden. The Zarit Burden Interview (ZBI) can measure the caregiver burden of caring for a family member with vision impairment. The purpose of this study is to validate the ZBI in Mexican family caregivers of patients with visual impairment.
Methods: The ZBI was applied to 137 family caregivers of patients with visual acuity ≤ 20/200 in the best eye for ≥ 6 months. The ZBI's reliability was determined using Cronbach's α and the factor structure using exploratory factor analysis (EFA, principal axis factoring with promax rotation). Items with loadings < 0.400 were eliminated. Retained factors were determined using the scree test and Horn's parallel analysis (95% CI). Associations between burden factors and other variables were evaluated with descriptive and inferential statistics.
Results: Mean ZBI score was 26.2 ± 13.1, and internal consistency was high (α = 0.871). EFA yielded four factors: (1) embarrassment and frustration, (2) self-efficacy expectations, (3) interference in personal relationships, and (4) personal strain. The α values ranged from 0.649 to 0.812. Spousal caregivers had significantly higher scores (factors 1, 2, and 4), whereas adult children had less scores (factor 3). There was a significant positive correlation between hours of daily caregiving and factors 2 (r = 0.350) and 3 (r = 0.388). A worse degree of visual impairment was associated with higher mean factor scores in all factors.
Conclusions: The ZBI is a valid instrument to detect burden in Mexican caregivers of patients with visual impairment. We identified a four-factor structure that improved our understanding of the ZBI's underlying constructs. Interventions targeting specific types of burden are warranted.
{"title":"Validation of the Zarit Burden Interview in Informal Caregivers of Patients with Severe Visual Impairment and Blindness.","authors":"Raul E Ruiz-Lozano, Monica I Herrera-Rodriguez, Jazmin A Mendoza-Pallares, Natalia Reyes-Godinez, Veronica E Tamez-Tamez, Eugenia M Ramos-Dávila, Luis G Villagomez-Valdez, Lucas A Garza-Garza, Manuel E Quiroga-Garza, Ali Khodor, Jose J Gongora-Cortes, Alejandro Rodriguez-Garcia","doi":"10.1007/s40123-024-01050-6","DOIUrl":"10.1007/s40123-024-01050-6","url":null,"abstract":"<p><strong>Introduction: </strong>The needs of family caregivers providing care to relatives with visual impairment are often dismissed, leading to caregiver burden. The Zarit Burden Interview (ZBI) can measure the caregiver burden of caring for a family member with vision impairment. The purpose of this study is to validate the ZBI in Mexican family caregivers of patients with visual impairment.</p><p><strong>Methods: </strong>The ZBI was applied to 137 family caregivers of patients with visual acuity ≤ 20/200 in the best eye for ≥ 6 months. The ZBI's reliability was determined using Cronbach's α and the factor structure using exploratory factor analysis (EFA, principal axis factoring with promax rotation). Items with loadings < 0.400 were eliminated. Retained factors were determined using the scree test and Horn's parallel analysis (95% CI). Associations between burden factors and other variables were evaluated with descriptive and inferential statistics.</p><p><strong>Results: </strong>Mean ZBI score was 26.2 ± 13.1, and internal consistency was high (α = 0.871). EFA yielded four factors: (1) embarrassment and frustration, (2) self-efficacy expectations, (3) interference in personal relationships, and (4) personal strain. The α values ranged from 0.649 to 0.812. Spousal caregivers had significantly higher scores (factors 1, 2, and 4), whereas adult children had less scores (factor 3). There was a significant positive correlation between hours of daily caregiving and factors 2 (r = 0.350) and 3 (r = 0.388). A worse degree of visual impairment was associated with higher mean factor scores in all factors.</p><p><strong>Conclusions: </strong>The ZBI is a valid instrument to detect burden in Mexican caregivers of patients with visual impairment. We identified a four-factor structure that improved our understanding of the ZBI's underlying constructs. Interventions targeting specific types of burden are warranted.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"55-71"},"PeriodicalIF":2.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724820/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142564883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-11-06DOI: 10.1007/s40123-024-01049-z
Andrzej Grzybowski, Piotr Brona, Tomasz Krzywicki, Paisan Ruamviboonsuk
Introduction: Automated diabetic retinopathy (DR) screening using artificial intelligence has the potential to improve access to eye care by enabling large-scale screening. However, little is known about differences in real-world performance between available algorithms. This study compares the diagnostic accuracy of two AI screening platforms, IDx-DR and RetCAD, for detecting referable diabetic retinopathy (RDR).
Methods: Retinal images from 758 patients with diabetes were collected during screening from various clinics in Poland. Each patient was graded by three graders with 320 patients graded by Polish and 438 patients graded by Indian graders, with the majority decision serving as the reference standard. The images were evaluated independently by the IDx-DR and RetCAD algorithms. Sensitivity, specificity, positive and negative predictive values, and agreement between algorithms and human graders were calculated and statistically compared.
Results: IDx-DR demonstrated higher sensitivity of 99.3% but lower specificity of 68.9% for RDR detection compared to RetCAD which had 89.4% sensitivity and 94.8% specificity. The positive predictive value was higher for RetCAD (96.4% vs 48.1% for IDx-DR) while the negative predictive value was higher for IDx-DR (99.5% vs 83.1% for RetCAD). Both algorithms achieved high sensitivity (> 95%) for sight-threatening diabetic retinopathy detection.
Conclusion: In this direct comparison using the same patient cohort, the two algorithms showed differences in their operating parameters for RDR screening. IDx-DR prioritized avoiding false negatives over false positives while RetCAD maintained a more balanced trade-off. These results highlight the variable performance of current artificial intelligence screening solutions and suggest the importance of considering algorithm performance metrics when deploying automated diabetic retinopathy screening programs, based on available healthcare resources.
{"title":"Diagnostic Accuracy of Automated Diabetic Retinopathy Image Assessment Software: IDx-DR and RetCAD.","authors":"Andrzej Grzybowski, Piotr Brona, Tomasz Krzywicki, Paisan Ruamviboonsuk","doi":"10.1007/s40123-024-01049-z","DOIUrl":"10.1007/s40123-024-01049-z","url":null,"abstract":"<p><strong>Introduction: </strong>Automated diabetic retinopathy (DR) screening using artificial intelligence has the potential to improve access to eye care by enabling large-scale screening. However, little is known about differences in real-world performance between available algorithms. This study compares the diagnostic accuracy of two AI screening platforms, IDx-DR and RetCAD, for detecting referable diabetic retinopathy (RDR).</p><p><strong>Methods: </strong>Retinal images from 758 patients with diabetes were collected during screening from various clinics in Poland. Each patient was graded by three graders with 320 patients graded by Polish and 438 patients graded by Indian graders, with the majority decision serving as the reference standard. The images were evaluated independently by the IDx-DR and RetCAD algorithms. Sensitivity, specificity, positive and negative predictive values, and agreement between algorithms and human graders were calculated and statistically compared.</p><p><strong>Results: </strong>IDx-DR demonstrated higher sensitivity of 99.3% but lower specificity of 68.9% for RDR detection compared to RetCAD which had 89.4% sensitivity and 94.8% specificity. The positive predictive value was higher for RetCAD (96.4% vs 48.1% for IDx-DR) while the negative predictive value was higher for IDx-DR (99.5% vs 83.1% for RetCAD). Both algorithms achieved high sensitivity (> 95%) for sight-threatening diabetic retinopathy detection.</p><p><strong>Conclusion: </strong>In this direct comparison using the same patient cohort, the two algorithms showed differences in their operating parameters for RDR screening. IDx-DR prioritized avoiding false negatives over false positives while RetCAD maintained a more balanced trade-off. These results highlight the variable performance of current artificial intelligence screening solutions and suggest the importance of considering algorithm performance metrics when deploying automated diabetic retinopathy screening programs, based on available healthcare resources.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"73-84"},"PeriodicalIF":2.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724818/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583948","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-11-22DOI: 10.1007/s40123-024-01067-x
Zubeyir Yozgat, Mehmed Ugur Isik, Mehmet Cem Sabaner
Introduction: The aim of this study was to compare the efficacy of the treat-and-extend (TAE) regimen versus the pro re nata (PRN) regimen in patients with bevacizumab-resistant diabetic macular edema (DME) treated with aflibercept, with or without adjunctive laser therapy.
Methods: Ninety-one eyes from 91 patients who were switched to aflibercept after three consecutive intravitreal bevacizumab injections for the treatment of DME were included in this retrospective real-world study. The patients were categorized into three groups: TAE (n = 30), TAE + laser (n = 31), and PRN (n = 30). Changes in best-corrected visual acuity and central macular subfield thickness (CMST) at 12, 24, and 52 weeks were defined as the primary functional and anatomical outcomes.
Results: A total of 91 eyes from 91 patients (49.5% female) with a mean age of 63.9 ± 7.1 years were included in the analysis. At 52 weeks, the mean letter gains were 8.03, 8.90, and 10.23 in the TAE, TAE + laser, and PRN groups, respectively. Anatomical improvements, as measured by CMST reduction, were 55.33 µm, 33.35 µm, and 48.96 µm in the TAE, TAE + laser, and PRN groups, respectively. The average number of injections administered was 7.7, 8.1, and 8.1, respectively. The final extension interval for the TAE group was 8.7 weeks, compared to 9.5 weeks in the TAE + laser group.
Conclusions: The PRN group demonstrated the highest functional improvement while the TAE group showed the greatest anatomical improvement. Overall, both anatomical and functional outcomes in the TAE regimen were comparable to the PRN regimen in patients with bevacizumab-resistant diabetic macular edema.
{"title":"One-Year Outcomes of Aflibercept in Treat-and-Extend Versus Pro Re Nata Regimens for Bevacizumab-Resistant Diabetic Macular Edema: A Real-World Study.","authors":"Zubeyir Yozgat, Mehmed Ugur Isik, Mehmet Cem Sabaner","doi":"10.1007/s40123-024-01067-x","DOIUrl":"10.1007/s40123-024-01067-x","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study was to compare the efficacy of the treat-and-extend (TAE) regimen versus the pro re nata (PRN) regimen in patients with bevacizumab-resistant diabetic macular edema (DME) treated with aflibercept, with or without adjunctive laser therapy.</p><p><strong>Methods: </strong>Ninety-one eyes from 91 patients who were switched to aflibercept after three consecutive intravitreal bevacizumab injections for the treatment of DME were included in this retrospective real-world study. The patients were categorized into three groups: TAE (n = 30), TAE + laser (n = 31), and PRN (n = 30). Changes in best-corrected visual acuity and central macular subfield thickness (CMST) at 12, 24, and 52 weeks were defined as the primary functional and anatomical outcomes.</p><p><strong>Results: </strong>A total of 91 eyes from 91 patients (49.5% female) with a mean age of 63.9 ± 7.1 years were included in the analysis. At 52 weeks, the mean letter gains were 8.03, 8.90, and 10.23 in the TAE, TAE + laser, and PRN groups, respectively. Anatomical improvements, as measured by CMST reduction, were 55.33 µm, 33.35 µm, and 48.96 µm in the TAE, TAE + laser, and PRN groups, respectively. The average number of injections administered was 7.7, 8.1, and 8.1, respectively. The final extension interval for the TAE group was 8.7 weeks, compared to 9.5 weeks in the TAE + laser group.</p><p><strong>Conclusions: </strong>The PRN group demonstrated the highest functional improvement while the TAE group showed the greatest anatomical improvement. Overall, both anatomical and functional outcomes in the TAE regimen were comparable to the PRN regimen in patients with bevacizumab-resistant diabetic macular edema.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"169-181"},"PeriodicalIF":2.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724814/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142686958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-12-05DOI: 10.1007/s40123-024-01068-w
Małgorzata Chilmonczyk, Kinga Gołaszewska, Emil Saeed, Joanna Konopińska
Glaucoma and cataract often coexist. Patients with both conditions who qualify for surgical treatment may undergo either a combined surgical procedure or sequential treatments such as cataract surgery followed by an antiglaucoma procedure. A combined procedure with phacoemulsification is related to an increased risk of fibrosis of the filtering bleb; however, it is a rational approach for patients with high intraocular pressure and clinically significant lens opacification. Trabeculectomy has been a traditional filtration procedure for decades, effectively lowering intraocular pressure. It is highly effective; however, it may cause sight-threatening complications. The Preserflo MicroShunt, introduced less than a decade ago in the field of glaucoma surgery, has shown similar hypotensive efficacy to trabeculectomy, and is a less invasive procedure with a better safety profile. Despite their shared mechanism of action to reduce intraocular pressure, the two procedures differ in the extent of scleral incision and filtration bleb morphology, which may influence the extent of the post-surgery inflammation process. This review evaluated and compared reports on the efficacy and safety of Preserflo MicroShunt implantation as a standalone procedure versus combined with cataract removal in surgical treatment for patients with open-angle glaucoma and concomitant cataract.
{"title":"Preserflo MicroShunt Implantation: A Narrative Review of Its Standalone Benefits vs. Combined Use with Phacoemulsification in Managing Open-Angle Glaucoma.","authors":"Małgorzata Chilmonczyk, Kinga Gołaszewska, Emil Saeed, Joanna Konopińska","doi":"10.1007/s40123-024-01068-w","DOIUrl":"10.1007/s40123-024-01068-w","url":null,"abstract":"<p><p>Glaucoma and cataract often coexist. Patients with both conditions who qualify for surgical treatment may undergo either a combined surgical procedure or sequential treatments such as cataract surgery followed by an antiglaucoma procedure. A combined procedure with phacoemulsification is related to an increased risk of fibrosis of the filtering bleb; however, it is a rational approach for patients with high intraocular pressure and clinically significant lens opacification. Trabeculectomy has been a traditional filtration procedure for decades, effectively lowering intraocular pressure. It is highly effective; however, it may cause sight-threatening complications. The Preserflo MicroShunt, introduced less than a decade ago in the field of glaucoma surgery, has shown similar hypotensive efficacy to trabeculectomy, and is a less invasive procedure with a better safety profile. Despite their shared mechanism of action to reduce intraocular pressure, the two procedures differ in the extent of scleral incision and filtration bleb morphology, which may influence the extent of the post-surgery inflammation process. This review evaluated and compared reports on the efficacy and safety of Preserflo MicroShunt implantation as a standalone procedure versus combined with cataract removal in surgical treatment for patients with open-angle glaucoma and concomitant cataract.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"41-54"},"PeriodicalIF":2.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724813/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142786213","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-11-06DOI: 10.1007/s40123-024-01043-5
Neungseon Seo, Scott Kuhns, Dina A Andrews, Alexander Colbert, Vincent Chow, Jennifer Liu
Introduction: ABP 938 is being developed as a biosimilar to Eylea® (aflibercept reference product [RP]), an anti-vascular endothelial growth factor (VEGF) drug used in the management of retinal diseases. Previously, a comparative analytical similarity assessment demonstrated that ABP 938 and aflibercept RP have the same amino acid sequence and exhibit similar higher-order structure and biological activity. The nonclinical studies described here were designed to assess the in vitro pharmacology and the in vivo pharmacokinetics (PK), toxicokinetics (TK), and safety profiles of ABP 938 compared to aflibercept RP.
Methods: In vitro target-binding kinetics and affinity for VEGF-A and placental growth factor (PIGF) isoforms were evaluated using surface plasmon resonance (SPR). Effector functions were assessed by cell-based assays. PK was evaluated in a nonterminal intravitreal (IVT) ocular distribution study in rabbits. Safety was assessed in a 1-month IVT study in cynomolgus monkeys.
Results: SPR results demonstrated that ABP 938 is similar to aflibercept RP in binding kinetics and affinity for VEGF-A111, VEGF-A121, VEGF-A165, VEGF-A189, PlGF-1, and PlGF-2 isoforms. No antibody-dependent cellular cytotoxicity, antibody-dependent cellular phagocytosis, or complement-dependent cytotoxicity was observed with ABP 938 and aflibercept RP. Results from the nonterminal ocular distribution study in rabbits indicated that there were no meaningful differences in the distribution kinetics between intravitreally injected ABP 938 and aflibercept RP. Additionally, there was no evidence of ocular or systemic toxicity associated with IVT administration of ABP 938 in a repeat-dose, 1-month toxicology study in cynomolgus monkeys; toxicokinetic and toxicology profiles were similar to aflibercept RP.
Conclusions: This integrated assessment of results from the in vitro pharmacology assessment and in vivo PK and TK/toxicology profiles formed the nonclinical portion of the totality of evidence demonstrating ABP 938 is a biosimilar to aflibercept RP.
{"title":"Nonclinical Similarity of the Biosimilar Candidate ABP 938 with Aflibercept Reference Product.","authors":"Neungseon Seo, Scott Kuhns, Dina A Andrews, Alexander Colbert, Vincent Chow, Jennifer Liu","doi":"10.1007/s40123-024-01043-5","DOIUrl":"10.1007/s40123-024-01043-5","url":null,"abstract":"<p><strong>Introduction: </strong>ABP 938 is being developed as a biosimilar to Eylea<sup>®</sup> (aflibercept reference product [RP]), an anti-vascular endothelial growth factor (VEGF) drug used in the management of retinal diseases. Previously, a comparative analytical similarity assessment demonstrated that ABP 938 and aflibercept RP have the same amino acid sequence and exhibit similar higher-order structure and biological activity. The nonclinical studies described here were designed to assess the in vitro pharmacology and the in vivo pharmacokinetics (PK), toxicokinetics (TK), and safety profiles of ABP 938 compared to aflibercept RP.</p><p><strong>Methods: </strong>In vitro target-binding kinetics and affinity for VEGF-A and placental growth factor (PIGF) isoforms were evaluated using surface plasmon resonance (SPR). Effector functions were assessed by cell-based assays. PK was evaluated in a nonterminal intravitreal (IVT) ocular distribution study in rabbits. Safety was assessed in a 1-month IVT study in cynomolgus monkeys.</p><p><strong>Results: </strong>SPR results demonstrated that ABP 938 is similar to aflibercept RP in binding kinetics and affinity for VEGF-A<sub>111</sub>, VEGF-A<sub>121</sub>, VEGF-A<sub>165</sub>, VEGF-A<sub>189</sub>, PlGF-1, and PlGF-2 isoforms. No antibody-dependent cellular cytotoxicity, antibody-dependent cellular phagocytosis, or complement-dependent cytotoxicity was observed with ABP 938 and aflibercept RP. Results from the nonterminal ocular distribution study in rabbits indicated that there were no meaningful differences in the distribution kinetics between intravitreally injected ABP 938 and aflibercept RP. Additionally, there was no evidence of ocular or systemic toxicity associated with IVT administration of ABP 938 in a repeat-dose, 1-month toxicology study in cynomolgus monkeys; toxicokinetic and toxicology profiles were similar to aflibercept RP.</p><p><strong>Conclusions: </strong>This integrated assessment of results from the in vitro pharmacology assessment and in vivo PK and TK/toxicology profiles formed the nonclinical portion of the totality of evidence demonstrating ABP 938 is a biosimilar to aflibercept RP.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"85-101"},"PeriodicalIF":2.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724829/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-11-08DOI: 10.1007/s40123-024-01066-y
Zichang Su, Kai Jin, Hongkang Wu, Ziyao Luo, Andrzej Grzybowski, Juan Ye
Introduction: Cataracts are a significant cause of blindness. While individuals frequently turn to the Internet for medical advice, distinguishing reliable information can be challenging. Large language models (LLMs) have attracted attention for generating accurate, human-like responses that may be used for medical consultation. However, a comprehensive assessment of LLMs' accuracy within specific medical domains is still lacking.
Methods: We compiled 46 commonly inquired questions related to cataract care, categorized into six domains. Each question was presented to the LLMs, and three consultant-level ophthalmologists independently assessed the accuracy of their responses on a three-point scale (poor, borderline, good) and their comprehensiveness on a five-point scale. A majority consensus approach established the final rating for each response. Responses rated as 'Poor' were prompted for self-correction and reassessed.
Results: For accuracy, ChatGPT-4o and Google Bard both achieved average sum scores of 8.7 (out of 9), followed by ChatGPT-3.5, Bing Chat, Llama 2, and Wenxin Yiyan. In consensus-based ratings, ChatGPT-4o outperformed Google Bard in the 'Good' rating. For completeness, ChatGPT-4o had the highest average sum score of 13.22 (out of 15), followed by Google Bard, ChatGPT-3.5, Llama 2, Bing Chat, and Wenxin Yiyan. Detailed performance data reveal nuanced differences in model capabilities. In the 'Prevention' domain, apart from Wenxin Yiyan, all other models were rated as 'Good'. All models showed improvement in self-correction. Bard and Bing improved 1/1 from 'Poor' to better, Llama improved 3/4, and Wenxin Yiyan improved 4/5.
Conclusions: Our findings emphasize the potential of LLMs, particularly ChatGPT-4o, to deliver accurate and comprehensive responses to cataract-related queries, especially in prevention, indicating potential for medical consultation. Continuous efforts to enhance LLMs' accuracy through ongoing strategies and evaluations are essential.
{"title":"Assessment of Large Language Models in Cataract Care Information Provision: A Quantitative Comparison.","authors":"Zichang Su, Kai Jin, Hongkang Wu, Ziyao Luo, Andrzej Grzybowski, Juan Ye","doi":"10.1007/s40123-024-01066-y","DOIUrl":"10.1007/s40123-024-01066-y","url":null,"abstract":"<p><strong>Introduction: </strong>Cataracts are a significant cause of blindness. While individuals frequently turn to the Internet for medical advice, distinguishing reliable information can be challenging. Large language models (LLMs) have attracted attention for generating accurate, human-like responses that may be used for medical consultation. However, a comprehensive assessment of LLMs' accuracy within specific medical domains is still lacking.</p><p><strong>Methods: </strong>We compiled 46 commonly inquired questions related to cataract care, categorized into six domains. Each question was presented to the LLMs, and three consultant-level ophthalmologists independently assessed the accuracy of their responses on a three-point scale (poor, borderline, good) and their comprehensiveness on a five-point scale. A majority consensus approach established the final rating for each response. Responses rated as 'Poor' were prompted for self-correction and reassessed.</p><p><strong>Results: </strong>For accuracy, ChatGPT-4o and Google Bard both achieved average sum scores of 8.7 (out of 9), followed by ChatGPT-3.5, Bing Chat, Llama 2, and Wenxin Yiyan. In consensus-based ratings, ChatGPT-4o outperformed Google Bard in the 'Good' rating. For completeness, ChatGPT-4o had the highest average sum score of 13.22 (out of 15), followed by Google Bard, ChatGPT-3.5, Llama 2, Bing Chat, and Wenxin Yiyan. Detailed performance data reveal nuanced differences in model capabilities. In the 'Prevention' domain, apart from Wenxin Yiyan, all other models were rated as 'Good'. All models showed improvement in self-correction. Bard and Bing improved 1/1 from 'Poor' to better, Llama improved 3/4, and Wenxin Yiyan improved 4/5.</p><p><strong>Conclusions: </strong>Our findings emphasize the potential of LLMs, particularly ChatGPT-4o, to deliver accurate and comprehensive responses to cataract-related queries, especially in prevention, indicating potential for medical consultation. Continuous efforts to enhance LLMs' accuracy through ongoing strategies and evaluations are essential.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"103-116"},"PeriodicalIF":2.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724831/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142625343","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-11-22DOI: 10.1007/s40123-024-01074-y
Nora Majtanova, Adriana Takacova, Veronika Kurilova, Libor Hejsek, Juraj Majtan, Petr Kolar
Introduction: This study was performed to compare the efficacy and safety of PreserFlo MicroShunt (PMS) implantation with mitomycin C (MMC) applied by sub-tenon injection versus conventional application by MMC-soaked sponges.
Methods: This retrospective, 1-year cohort study included 100 eyes of 100 patients with glaucoma who underwent PMS implantation with MMC (0.4 mg/ml) delivered either by sub-tenon injection (50 eyes) or via soaked sponges (50 eyes). The primary outcome measure at 1 year was intraocular pressure (IOP) reduction, with complete success defined as an IOP reduction of ≥ 20% and achieving a target IOP of ≤ 21 or 18 mmHg without the use of medication. Secondary outcomes, including corneal endothelial cell density (CECD) loss, the number of medications, and complications, were assessed and compared between the groups.
Results: Sustained reductions in mean IOP were observed in both groups over the 1-year follow-up, with no significant differences between the groups. The complete success rate, with a target IOP of ≤ 21 mmHg after 1 year, was 19.3% in the sponge group and 26.4% in the injection group. The qualified success rate was 59.0% and 87.4% in the sponge and injection groups, respectively. A longer survival rate was observed in the injection group than in the sponge group when IOP was below 21 mmHg. The mean CECD significantly decreased (P < 0.01) from baseline to each postoperative follow-up time point in both groups. At 1 year postoperatively, the percentage of total CECD loss was 8.1% in the sponge group and 8.0% in the injection group. However, no significant differences in mean CECD values, the number of medications, or adverse events were found between the groups.
Conclusions: PMS implantation with sub-tenon injection of MMC was comparable in terms of efficacy and safety to traditional MMC delivery via soaked sponges. However, the injection group demonstrated a significantly higher success rate than the sponge group.
{"title":"One-Year Comparison of Efficacy and Safety of PreserFlo MicroShunt with Mitomycin C Applied by Sub-Tenon Injection Versus Sponge.","authors":"Nora Majtanova, Adriana Takacova, Veronika Kurilova, Libor Hejsek, Juraj Majtan, Petr Kolar","doi":"10.1007/s40123-024-01074-y","DOIUrl":"10.1007/s40123-024-01074-y","url":null,"abstract":"<p><strong>Introduction: </strong>This study was performed to compare the efficacy and safety of PreserFlo MicroShunt (PMS) implantation with mitomycin C (MMC) applied by sub-tenon injection versus conventional application by MMC-soaked sponges.</p><p><strong>Methods: </strong>This retrospective, 1-year cohort study included 100 eyes of 100 patients with glaucoma who underwent PMS implantation with MMC (0.4 mg/ml) delivered either by sub-tenon injection (50 eyes) or via soaked sponges (50 eyes). The primary outcome measure at 1 year was intraocular pressure (IOP) reduction, with complete success defined as an IOP reduction of ≥ 20% and achieving a target IOP of ≤ 21 or 18 mmHg without the use of medication. Secondary outcomes, including corneal endothelial cell density (CECD) loss, the number of medications, and complications, were assessed and compared between the groups.</p><p><strong>Results: </strong>Sustained reductions in mean IOP were observed in both groups over the 1-year follow-up, with no significant differences between the groups. The complete success rate, with a target IOP of ≤ 21 mmHg after 1 year, was 19.3% in the sponge group and 26.4% in the injection group. The qualified success rate was 59.0% and 87.4% in the sponge and injection groups, respectively. A longer survival rate was observed in the injection group than in the sponge group when IOP was below 21 mmHg. The mean CECD significantly decreased (P < 0.01) from baseline to each postoperative follow-up time point in both groups. At 1 year postoperatively, the percentage of total CECD loss was 8.1% in the sponge group and 8.0% in the injection group. However, no significant differences in mean CECD values, the number of medications, or adverse events were found between the groups.</p><p><strong>Conclusions: </strong>PMS implantation with sub-tenon injection of MMC was comparable in terms of efficacy and safety to traditional MMC delivery via soaked sponges. However, the injection group demonstrated a significantly higher success rate than the sponge group.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"153-167"},"PeriodicalIF":2.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724825/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142686751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: This study investigated the effects of automatic dual rotational Risley prisms (ADRRPs), a mobile phone application-operated device, on vergence abilities in young adults.
Methods: Fifty-six participants aged 20-24 performed vergence exercises. The test group used prisms with power changes from 30Δ base-out to 10Δ base-in, while the control group used plano lenses for 10 min. Ophthalmic examinations included lateral heterophoria, near point of convergence (NPC), vergence facility (VF), negative fusional vergence (NFV), and positive fusional vergence (PFV), all measured before and after the vergence exercises. Pre- and post-test results were analyzed using a paired sample t test. Additionally, three cases with convergence insufficiency (CI) performed similar exercises for 12 weeks.
Results: Participants were divided into the test group (n = 39; age 21.82 ± 1.10 years) and control group (n = 17; age 20.53 ± 0.51 years). In the test group, NPC improved from 6.11 ± 2.52 cm to 5.77 ± 2.30 cm (p = 0.023). VF increased from 13.75 ± 4.10 cpm to 16.50 ± 4.42 cpm (p = 0.007). PFV at 6 m and 0.4 m increased from 19.49 ± 6.77∆ to 22.19 ± 6.64∆ (p < 0.001) and 20.51 ± 7.05∆ to 22.69 ± 6.44∆ (p = 0.012), respectively. After 12 weeks, convergence insufficiency symptom survey scores for cases with CI decreased significantly, with NPC improving from 7.0 to 0 cm, 6.0 to 5.8 cm, and 6.0 to 4.7 cm. PFV increased from 10 to 25∆, 20 to 30∆, and 25 to 50∆.
Conclusion: This preliminary study showed the effect of ADRRPs on improving vergence abilities. Further studies are needed to investigate the long-term sustainability and effects in a larger population of individuals with CI of this approach.
{"title":"A Novel Device for Vergence Exercises: Testing Automatic Dual Rotational Risley Prisms on Asymptomatic Adults and Patients with Convergence Insufficiency.","authors":"Ya-Yu Chen, Yun-Shao Hu, Shuan-Yu Huang, Tzu-Hsun Tsai","doi":"10.1007/s40123-024-01055-1","DOIUrl":"10.1007/s40123-024-01055-1","url":null,"abstract":"<p><strong>Introduction: </strong>This study investigated the effects of automatic dual rotational Risley prisms (ADRRPs), a mobile phone application-operated device, on vergence abilities in young adults.</p><p><strong>Methods: </strong>Fifty-six participants aged 20-24 performed vergence exercises. The test group used prisms with power changes from 30Δ base-out to 10Δ base-in, while the control group used plano lenses for 10 min. Ophthalmic examinations included lateral heterophoria, near point of convergence (NPC), vergence facility (VF), negative fusional vergence (NFV), and positive fusional vergence (PFV), all measured before and after the vergence exercises. Pre- and post-test results were analyzed using a paired sample t test. Additionally, three cases with convergence insufficiency (CI) performed similar exercises for 12 weeks.</p><p><strong>Results: </strong>Participants were divided into the test group (n = 39; age 21.82 ± 1.10 years) and control group (n = 17; age 20.53 ± 0.51 years). In the test group, NPC improved from 6.11 ± 2.52 cm to 5.77 ± 2.30 cm (p = 0.023). VF increased from 13.75 ± 4.10 cpm to 16.50 ± 4.42 cpm (p = 0.007). PFV at 6 m and 0.4 m increased from 19.49 ± 6.77∆ to 22.19 ± 6.64∆ (p < 0.001) and 20.51 ± 7.05∆ to 22.69 ± 6.44∆ (p = 0.012), respectively. After 12 weeks, convergence insufficiency symptom survey scores for cases with CI decreased significantly, with NPC improving from 7.0 to 0 cm, 6.0 to 5.8 cm, and 6.0 to 4.7 cm. PFV increased from 10 to 25∆, 20 to 30∆, and 25 to 50∆.</p><p><strong>Conclusion: </strong>This preliminary study showed the effect of ADRRPs on improving vergence abilities. Further studies are needed to investigate the long-term sustainability and effects in a larger population of individuals with CI of this approach.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"3189-3201"},"PeriodicalIF":2.6,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11564504/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142522610","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}