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Overview of 37 Tear Substitutes in Europe Based on Various Physicochemical Parameters. 基于各种理化参数的欧洲 37 种泪液替代品概览。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-10-01 Epub Date: 2024-09-03 DOI: 10.1007/s40123-024-01023-9
Adrien Paschier, Aurélie Manuelli, Laure Chauchat, Morgane Legall, Hayette Rebika, Marwan Sahyoun, Camille Guerin

Introduction: Dry eye disease (DED) is one of the most prevalent eye conditions worldwide, with artificial tears serving as a primary treatment option. Despite their wide availability on the European market, there is a lack of established classifications based on their physicochemical properties. The aim of our study was therefore (i) to develop an analytical method that measures the concentration and the molecular weight (MW) of the hyaluronic acid (HA) in commercialized products, and (ii) to propose an overview based on their various physicochemical parameters.

Methods: The intrinsic viscosity and MW of the HA, as well as osmolarity, pH, rheological profile, and viscosity, were measured or determined. A specific method was developed to measure the average intrinsic viscosity and HA content using a liquid size-exclusion chromatography system. The MW was determined using the Mark-Houwink equation.

Results: Thirty-seven products commercialized in Europe were analyzed, with 21 of them containing HA. The HA MW was lowest (300 kDa) for Thealose®, Thealoz Duo® Gel, and Hyabak®, and highest (1300 kDa) for Vismed® Multi, Vismed® Gel, and Neovis® Gel. The pH values varied between 5.94 for Treovis® and 8.06 for Systane® Ultra. Osmolarity ranged between 148 mOsm/L and 325 mOsm/L for Neovis® and Treovis®, respectively. Viscosity was highly variable, ranging from 0.38 mPas·s for Hylolipid® to 337.47 mPas·s for Thealoz® Duo Gel. Finally, rheological profile analysis revealed different shear-thinning behaviors.

Conclusion: While the perfect eye drop does not exist, a multitude of options are available to choose from. This study improves our understanding of the major tear substitutes available on the European market based on several physicochemical properties. A better understanding and awareness of these parameters is crucial in order to offer the best treatment for patients with DED.

简介干眼症(DED)是全球最常见的眼部疾病之一,人工泪液是主要的治疗方法。尽管人工泪液在欧洲市场上广泛供应,但缺乏基于其物理化学特性的既定分类。因此,我们的研究目的是:(i) 开发一种分析方法,测量商业化产品中透明质酸(HA)的浓度和分子量(MW);(ii) 根据其各种理化参数提出一个概述:方法:测量或确定透明质酸的固有粘度和分子量,以及渗透压、pH 值、流变曲线和粘度。开发了一种特定方法,使用液体尺寸排阻色谱系统测量平均固有粘度和 HA 含量。使用 Mark-Houwink 公式确定了 MW:结果:分析了欧洲 37 种商业化产品,其中 21 种含有 HA。Thealose®、Thealoz Duo® Gel 和 Hyabak® 的 HA 最大分子量最低(300 kDa),Vismed® Multi、Vismed® Gel 和 Neovis® Gel 的 HA 最大分子量最高(1300 kDa)。Treovis® 和 Systane® Ultra 的 pH 值分别为 5.94 和 8.06。Neovis® 和 Treovis® 的渗透压分别在 148 mOsm/L 和 325 mOsm/L 之间。粘度变化很大,从 Hylolipid® 的 0.38 mPas-s 到 Thealoz® Duo Gel 的 337.47 mPas-s。最后,流变曲线分析显示了不同的剪切稀化行为:结论:虽然完美的滴眼液并不存在,但有多种选择可供选择。这项研究根据几种物理化学特性加深了我们对欧洲市场上主要泪液替代品的了解。更好地了解和认识这些参数对于为 DED 患者提供最佳治疗至关重要。
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引用次数: 0
Long-Term Impacts of Intense Pulsed Light Therapy on Ocular Surface Health and Tear Film Dynamics in Patients with Dry Eye Disease: Detailed Analysis and Observations Over a 1-Year Follow-Up Period. 强脉冲光疗法对干眼症患者眼表健康和泪膜动力学的长期影响:一年随访期的详细分析和观察。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-10-01 Epub Date: 2024-08-16 DOI: 10.1007/s40123-024-01017-7
Cristina-Patricia Pac, Mihnea Munteanu, José-María Sánchez-González, Carlos Rocha-de-Lossada, Nadina Mercea, Francis Ferrari, Horia T Stanca, Dan Andrei Radu Cosnita, Mihaela Ionica, Ovidiu Boruga, Ciprian Danielescu, Alexandru Blidisel

Introduction: To evaluate the long-term effects of intense pulsed light (IPL) therapy on patients with dry eye disease (DED) associated with meibomian gland dysfunction (MGD).

Methods: A retrospective case series was performed with 110 participants undergoing IPL therapy. Assessments included the eye fitness test (EFT) to gauge subjective symptoms, along with objective measures using the Tearcheck® device (ESW Vision, Houdan, France) noninvasive first breakup time (NIFBUT), noninvasive average breakup time (NIABUT), central tear meniscus height (CTMH), thinnest tear meniscus height (TTMH), and ocular surface inflammatory risk evaluation (OSIE) assessed using the SCHWIND SIRIUS device (SCHWIND eye-tech-solutions GmbH, Kleinostheim, Germany).

Results: This study documented significant improvements in subjective and objective symptoms associated with DED and MGD. Subjective symptoms measured by the EFT showed an average increase of 9.74 points (range -10 to 28, standard deviation [SD] ± 7.54), indicating reduced symptoms. Objective measures of tear film stability, represented by NIABUT, increased by an average of 4.04 s (range -15.00 to 14.40, SD ± 4.91). Tear film stability evaluation (TFSE) scores decreased by 229.12 points on average (range -1775 to 528, SD ± 384.94), suggesting enhanced tear film stability. OSIE type 1 showed a reduction in inflammation, with a percentage decrease of 4.98% (range -45 to 5, SD ± 7.33). Additionally, OSIE capture time decreased by 3.25 s on average (range -27 to 22, SD ± 10.35), further indicating an improvement in ocular surface health.

Conclusion: IPL therapy was shown to be a promising, noninvasive approach for improving quality of life in patients with DED by effectively managing symptoms and stabilizing tear film. The findings support the use of IPL as a sustainable treatment modality for DED associated with MGD.

简介:目的:评估强脉冲光疗法对伴有睑板腺功能障碍(MGD)的干眼症(DED)患者的长期影响:评估强脉冲光(IPL)疗法对伴有睑板腺功能障碍(MGD)的干眼症(DED)患者的长期影响:方法:对110名接受强脉冲光治疗的患者进行了回顾性病例系列研究。方法:对接受 IPL 治疗的 110 名参与者进行了回顾性病例系列研究。评估包括眼部健康测试 (EFT),以衡量主观症状,以及使用 Tearcheck® 设备(ESW Vision,法国胡丹)进行的客观测量,包括无创首次泪液破裂时间 (NIFBUT)、无创平均泪液破裂时间 (NIABUT)、中心泪液半月板高度(CTMH)、最薄泪液半月板高度(TTMH),以及使用 SCHWIND SIRIUS 设备(SCHWIND eye-tech-solutions GmbH,德国 Kleinostheim)进行的眼表炎症风险评估(OSIE)。研究结果这项研究表明,与 DED 和 MGD 相关的主观和客观症状均有明显改善。通过 EFT 测量的主观症状平均增加了 9.74 分(范围为-10 至 28,标准差 [SD] ± 7.54),表明症状有所减轻。以 NIABUT 为代表的泪膜稳定性客观指标平均增加了 4.04 秒(范围-15.00 至 14.40,标准差 ± 4.91)。泪膜稳定性评估(TFSE)得分平均降低了 229.12 分(范围为 -1775-528,标准差 ± 384.94),表明泪膜稳定性增强。OSIE 1 型显示炎症有所减轻,百分比下降了 4.98%(范围-45 至 5,标准差 ± 7.33)。此外,OSIE捕捉时间平均减少了3.25秒(范围-27至22,标准差±10.35),进一步表明眼表健康得到了改善:结论:IPL疗法通过有效控制症状和稳定泪膜,被证明是改善DED患者生活质量的一种很有前景的非侵入性方法。研究结果支持将 IPL 作为一种可持续的治疗方式,用于治疗伴有 MGD 的 DED。
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引用次数: 0
Clinical Outcomes of Excisional Goniotomy with the Kahook Dual Blade: 6-Year Results. 使用 Kahook 双刀进行割除性神经节切除术的临床效果:6 年结果。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-10-01 Epub Date: 2024-08-16 DOI: 10.1007/s40123-024-01016-8
Pranav Vasu, Yazan Abubaker, Nithya Boopathiraj, Isabella V Wagner, P Connor Lentz, Emily Dorairaj, Aya Shokair, Ibrahim Qozat, Darby D Miller, Syril Dorairaj

Introduction: This study aims to evaluate the long-term clinical outcomes of excisional goniotomy with the Kahook Dual Blade (KDB) in the management of various types of glaucoma.

Methods: This was a retrospective, noncomparative chart review of 90 eyes of 53 patients with glaucoma that underwent standalone KDB goniotomy (KDB-alone group) or KDB goniotomy with concomitant phacoemulsification (KDB-phaco group) between October 2015 and October 2017. Surgical success was defined as an intraocular pressure (IOP) reduction by ≥ 20% at the last follow-up with no surgical reinterventions required and a final IOP ≥ 4 mmHg and ≤ 21 mmHg. We also report on changes from baseline in IOP, number of glaucoma medications, best-corrected visual acuity (BCVA), and visual field parameters, for up to 72 months.

Results: At 72 months, mean (standard deviation [SD]) IOP was reduced from 17.5 (5.7) to 13.6 (3.0) mmHg (P < 0.0001) in the KDB-phaco group and from 23.3 (5.9) to 15.1 (6.2) mmHg (P = 0.0593) in the KDB-alone group. The mean (SD) number of glaucoma medications was reduced from 1.3 (1.0) to 0.8 (0.9) (P < 0.0001) in the KDB-phaco group and from 1.2 (1.0) to 0.7 (0.8) (P = 0.3409) in the KDB-alone group. During the 72-month follow-up, surgical success was achieved in 24 of the 52 available eyes (46.2%). Four eyes underwent a glaucoma surgical reintervention by 72 months.

Conclusions: Excisional goniotomy with the KDB effectively lowered the IOP (by an average of 28.0% from baseline) and maintained or further reduced glaucoma medication burdens (by an average of 30.8% from baseline) under an excellent safety profile, independent of phacoemulsification status. The procedure exhibited favorable success for up to 6 years, providing valuable insights into its long-term efficacy as a glaucoma treatment.

简介:本研究旨在评估在治疗各种类型的青光眼时使用 Kahook 双刀(KDB)进行眼球切开术的长期临床效果:本研究旨在评估使用 Kahook 双刀(KDB)进行眼球切开术治疗各种类型青光眼的长期临床疗效:这是对2015年10月至2017年10月期间53名青光眼患者的90只眼睛进行的回顾性、非比较性病历回顾,这些患者接受了独立的KDB开孔术(KDB-onalone组)或KDB开孔术并同时进行了乳化术(KDB-phaco组)。手术成功的定义是:最后一次随访时眼压(IOP)降低≥20%,且无需再次手术干预,最终眼压≥4 mmHg且≤21 mmHg。我们还报告了 72 个月内眼压、青光眼用药次数、最佳矫正视力(BCVA)和视野参数与基线相比的变化情况:结果:72 个月后,平均(标准差 [SD])眼压从 17.5(5.7)毫米汞柱降至 13.6(3.0)毫米汞柱(P 结论:眼压降低的主要原因是青光眼药物的数量减少:使用 KDB 进行切除性开颅手术能有效降低眼压(与基线值相比平均降低 28.0%),维持或进一步减少青光眼药物负担(与基线值相比平均降低 30.8%),且安全性极佳,不受超声乳化状态的影响。该手术在长达 6 年的时间里取得了良好的成功,为其作为青光眼治疗方法的长期疗效提供了宝贵的见解。
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引用次数: 0
High-Dose Brolucizumab for Refractory Neovascular Age-Related Macular Degeneration Resistant to Standard-Dose Brolucizumab. 大剂量布卢珠单抗治疗对标准剂量布卢珠单抗耐药的难治性新生血管性老年性黄斑变性。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-10-01 Epub Date: 2024-08-30 DOI: 10.1007/s40123-024-01022-w
Jinsoo Kim, Min Seon Park, Bum-Joo Cho, Soonil Kwon

Introduction: The aim of this study was to evaluate the efficacy and safety of escalating the dosage of intravitreal brolucizumab in patients with refractory neovascular age-related macular degeneration (AMD).

Methods: This retrospective study included 17 eyes of 17 patients with refractory AMD treated with high-dose brolucizumab (12 mg/0.1 ml) for over 12 months. Patients initially received at least one anti-vascular endothelial growth factor (anti-VEGF) agent and were switched to standard-dose brolucizumab (6 mg/0.05 ml). Those who showed a suboptimal response to standard-dose treatment had their dosage of brolucizumab escalated.

Results: Visual acuity was maintained from 68.3 ± 3.4 letters to 70.7 ± 3.2 letters after 12 months of high-dose treatment (P = 0.128). Central subfield thickness was 343.7 ± 17.0 μm before high-dose treatment and 316.7 ± 18.5 μm at 12 months (P = 0.083). The proportions of patients with subretinal fluid and serous pigment epithelial detachment significantly decreased from 82.4% to 41.2% and from 52.9% to 17.6%, respectively, after high-dose treatment (P = 0.039 and P = 0.031, respectively). The treatment interval extended from 7.2 ± 2.4 weeks to 10.2 ± 2.2 weeks after switching to standard-dose brolucizumab (P < 0.001) and was maintained at 13.5 ± 2.8 weeks after increasing the dose (P = 0.154). No severe ocular adverse events were observed.

Conclusions: High-dose brolucizumab was effective in patients who did not respond to standard-dose brolucizumab after switching from previous anti-VEGF agents. Increasing the dosage could offer sustained disease control and reduce the treatment burden for patients with refractory AMD.

简介本研究旨在评估在难治性新生血管性年龄相关性黄斑变性(AMD)患者中增加玻璃体内brolucizumab剂量的有效性和安全性:这项回顾性研究纳入了17名难治性AMD患者的17只眼睛,他们接受了12个多月的高剂量brolucizumab(12毫克/0.1毫升)治疗。患者最初至少接受了一种抗血管内皮生长因子(anti-VEGF)药物治疗,之后转用标准剂量的brolucizumab(6毫克/0.05毫升)。那些对标准剂量治疗反应不佳的患者,其布卢单抗的剂量则会增加:高剂量治疗 12 个月后,视力从 68.3 ± 3.4 个字母维持到 70.7 ± 3.2 个字母(P = 0.128)。大剂量治疗前,中心视野下厚度为 343.7 ± 17.0 μm,12 个月后为 316.7 ± 18.5 μm(P = 0.083)。大剂量治疗后,视网膜下积液和浆液性色素上皮脱落患者的比例分别从 82.4% 和 52.9% 显著降至 41.2% 和 17.6%(P = 0.039 和 P = 0.031)。改用标准剂量博卢单抗后,治疗间隔从(7.2±2.4)周延长至(10.2±2.2)周(P 结论:标准剂量博卢单抗的治疗间隔从(7.2±2.4)周延长至(10.2±2.2)周:对于从以前的抗血管内皮生长因子药物转为标准剂量的博路单抗无效的患者来说,大剂量博路单抗是有效的。增加剂量可为难治性AMD患者提供持续的疾病控制并减轻治疗负担。
{"title":"High-Dose Brolucizumab for Refractory Neovascular Age-Related Macular Degeneration Resistant to Standard-Dose Brolucizumab.","authors":"Jinsoo Kim, Min Seon Park, Bum-Joo Cho, Soonil Kwon","doi":"10.1007/s40123-024-01022-w","DOIUrl":"10.1007/s40123-024-01022-w","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study was to evaluate the efficacy and safety of escalating the dosage of intravitreal brolucizumab in patients with refractory neovascular age-related macular degeneration (AMD).</p><p><strong>Methods: </strong>This retrospective study included 17 eyes of 17 patients with refractory AMD treated with high-dose brolucizumab (12 mg/0.1 ml) for over 12 months. Patients initially received at least one anti-vascular endothelial growth factor (anti-VEGF) agent and were switched to standard-dose brolucizumab (6 mg/0.05 ml). Those who showed a suboptimal response to standard-dose treatment had their dosage of brolucizumab escalated.</p><p><strong>Results: </strong>Visual acuity was maintained from 68.3 ± 3.4 letters to 70.7 ± 3.2 letters after 12 months of high-dose treatment (P = 0.128). Central subfield thickness was 343.7 ± 17.0 μm before high-dose treatment and 316.7 ± 18.5 μm at 12 months (P = 0.083). The proportions of patients with subretinal fluid and serous pigment epithelial detachment significantly decreased from 82.4% to 41.2% and from 52.9% to 17.6%, respectively, after high-dose treatment (P = 0.039 and P = 0.031, respectively). The treatment interval extended from 7.2 ± 2.4 weeks to 10.2 ± 2.2 weeks after switching to standard-dose brolucizumab (P < 0.001) and was maintained at 13.5 ± 2.8 weeks after increasing the dose (P = 0.154). No severe ocular adverse events were observed.</p><p><strong>Conclusions: </strong>High-dose brolucizumab was effective in patients who did not respond to standard-dose brolucizumab after switching from previous anti-VEGF agents. Increasing the dosage could offer sustained disease control and reduce the treatment burden for patients with refractory AMD.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"2789-2797"},"PeriodicalIF":2.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11408427/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142110495","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}
引用次数: 0
Economic Assessment in Resource-Constrained Systems: Individual-Level Simulation Model in Wet Age-Related Macular Degeneration and Diabetic Macular Oedema. 资源受限系统中的经济评估:湿性老年性黄斑变性和糖尿病性黄斑水肿的个体水平模拟模型。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-10-01 Epub Date: 2024-08-06 DOI: 10.1007/s40123-024-00999-8
Tara Li, Vladislav Berdunov, Robin Hamilton, Yaneth Gil Rojas, Christian Bührer, Oliver Cox, Roelien Postema, Marloes Bagijn

Introduction: Cost-effectiveness analyses typically ignore healthcare system resource constraints. Ophthalmology is affected by resource constraints because of increasing disease prevalence and the use of resource-intensive treatments. This study evaluated the impact of resource constraints on the cost-effectiveness of faricimab 6 mg, compared with aflibercept 2 mg and ranibizumab biosimilar 0.5 mg, for treating wet age-related macular degeneration (wAMD) or diabetic macular oedema (DMO) over a 5-year horizon.

Methods: A microsimulation model estimated the impact of resource constraints on patients visits, delays, costs and quality-adjusted life-year (QALY) losses due to treatment delays at a typical UK National Health Service eye hospital treating 1500 patients with wAMD and 500 patients with DMO. Patient characteristics, treatment regimens and treatment intervals were informed using published literature and expert opinion. Resource constraint was represented by limiting the number of available intravitreal injection appointments per week, with growing demand caused by rising disease prevalence. The model compared outcomes across three scenarios; each scenario involved treating all patients with one of the three treatments.

Results: Over 5 years, in a resource-constrained hospital, compared with aflibercept, faricimab use resulted in the avoidance of 12,596 delays, saved GBP/£15,108,609 in cost and avoided the loss of 60.06 QALYs. Compared with ranibizumab biosimilar, faricimab use resulted in the avoidance of 18,910 delays, incurred £2,069,088 extra cost and avoided the loss of 105.70 QALYs, resulting in an incremental cost-effectiveness ratio of £19,574/QALY.

Conclusions: Accounting for resource constraints in health economic evaluation is crucial. Emerging therapies that are more durable and require less frequent clinic visits can reduce treatment delays, leading to improved QALY outcomes and reduced burden on healthcare systems. Faricimab reduced the number of delayed injections, leading to improved QALY outcomes for patients in a healthcare system with resource constraints. Faricimab is cost-saving when compared with aflibercept and cost-effective when compared with ranibizumab biosimilar.

介绍:成本效益分析通常会忽略医疗系统的资源限制。由于眼科疾病的发病率越来越高,而且需要使用资源密集型治疗方法,因此眼科受到了资源限制的影响。本研究评估了资源限制对法尼单抗 6 毫克治疗湿性老年性黄斑变性(wAMD)或糖尿病性黄斑水肿(DMO)5 年成本效益的影响:一个微观模拟模型估算了资源限制对患者就诊、治疗延误、成本以及治疗延误导致的质量调整生命年(QALY)损失的影响。患者特征、治疗方案和治疗间隔均参考了已发表的文献和专家意见。资源限制表现为每周可用的玻璃体内注射预约次数有限,而疾病患病率的上升导致需求不断增加。该模型比较了三种情况下的结果;每种情况下都对所有患者采用三种治疗方法中的一种:在一家资源有限的医院,与阿弗利贝赛相比,法尼单抗的使用在 5 年内避免了 12,596 次延误,节约了 15,108,609 英镑的成本,并避免了 60.06 QALYs 的损失。与雷尼珠单抗生物类似药相比,使用法尼单抗可避免18,910次延误,节省额外成本2,069,088英镑,避免损失105.70 QALY,增量成本效益比为19,574英镑/QALY:结论:在卫生经济评估中考虑资源限制至关重要。新出现的疗法更持久,需要的就诊次数更少,可以减少治疗延迟,从而改善QALY结果,减轻医疗系统的负担。法利单抗减少了延迟注射的次数,从而改善了资源有限的医疗系统中患者的 QALY 结果。与阿夫利百普相比,法利单抗可节省成本,与雷尼珠单抗生物类似物相比,法利单抗具有成本效益。
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引用次数: 0
Observational Clinical Investigation Evaluating an Ophthalmic Solution Containing Xanthan Gum and Low Concentration Desonide Phosphate in Dry Eye Disease Treatment. 观察性临床研究:评估含黄原胶和低浓度磷酸地索奈德的眼科溶液在干眼症治疗中的应用。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-10-01 Epub Date: 2024-07-26 DOI: 10.1007/s40123-024-01003-z
Pasquale Aragona, Giuseppe Giannaccare, Edoardo Dammino, Fabiana D'Esposito, Paola Genovese, Elisa Imelde Postorino, Claudine Civiale, Maria Grazia Mazzone, Caterina Gagliano

Introduction: Patients with dry eye disease (DED) complain of a multitude of symptoms that affect their visual function and quality of life (QoL). This clinical investigation assessed the performance, tolerance, and safety of a novel preservative-free ophthalmic solution containing xanthan gum 0.2% and desonide sodium phosphate 0.025%.

Methods: This was an observational, prospective, multicentric, and post-market clinical investigation to assess the effect of three times a day instillation of the study formulation in patients suffering from DED. The primary objective was to achieve a 50% reduction in conjunctival hyperemia index as assessed with the OCULUS Keratograph after 1 month of treatment compared to baseline values. The secondary objectives included patient-reported outcomes, clinical performance, and safety.

Results: Thirty patients were enrolled (21 women, 9 men) with a mean age of 61.10 ± 14.53 years. The instillation of the study formulation was associated with a significant reduction in redness scores after 1 month of treatment compared to baseline (mean - 0.51 ± 0.51; p ≤ 0.0001). Although the primary endpoint was not completely met, a 50% reduction in the conjunctival hyperemia index was achieved in 23% of the participants, and 77% showed a reduction of 26% of the same index. In addition, the ophthalmic solution significantly increased tear film break-up time, and a significant reduction of corneal and conjunctival staining with fluorescein was achieved. It also reduced DED symptoms and had a very good safety profile.

Conclusions: the study formulation produced a significant improvement in the signs, symptoms, and QoL of patients with mild to moderate DED with a good safety profile after 1 month of treatment.

简介:干眼症(DED)患者会出现多种症状,影响其视觉功能和生活质量(QoL)。这项临床研究评估了一种不含防腐剂的新型眼科溶液(含黄原胶 0.2% 和地索奈德磷酸钠 0.025%)的性能、耐受性和安全性:这是一项观察性、前瞻性、多中心和上市后临床调查,目的是评估一天三次灌注研究配方对DED患者的影响。首要目标是在治疗1个月后,用OCULUS角膜成像仪评估的结膜充血指数与基线值相比降低50%。次要目标包括患者报告结果、临床表现和安全性:共招募了 30 名患者(21 名女性,9 名男性),平均年龄为 61.10 ± 14.53 岁。与基线相比,灌注研究配方治疗 1 个月后,发红评分显著降低(平均值 - 0.51 ± 0.51;P ≤ 0.0001)。虽然没有完全达到主要终点,但有 23% 的参与者结膜充血指数降低了 50%,77% 的参与者结膜充血指数降低了 26%。此外,该眼药水还显著延长了泪膜破裂时间,并显著减少了荧光素对角膜和结膜的染色。结论:经过 1 个月的治疗,研究配方对轻度至中度 DED 患者的体征、症状和 QoL 有明显改善,安全性良好。
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引用次数: 0
Exploring the Potential of Code-Free Custom GPTs in Ophthalmology: An Early Analysis of GPT Store and User-Creator Guidance. 探索无代码定制 GPT 在眼科领域的应用潜力:GPT 存储和用户创建指南的早期分析。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-10-01 Epub Date: 2024-08-14 DOI: 10.1007/s40123-024-01014-w
Aslan Aykut, Almila Sarigul Sezenoz

Introduction: OpenAI recently introduced the ability to create custom generative pre-trained transformers (cGPTs) using text-based instruction and/or external documents using retrieval-augmented generation (RAG) architecture without coding knowledge. This study aimed to analyze the features of ophthalmology-related cGPTs and explore their potential utilities.

Methods: Data collection took place on January 20 and 21, 2024, and custom GPTs were found by entering ophthalmology keywords into the "Explore GPTS" section of the website. General and specific features of cGPTs were recorded, such as knowledge other than GPT-4 training data. The instruction and description sections were analyzed for compatibility using the Likert scale. We analyzed two custom GPTs with the highest Likert score in detail. We attempted to create a convincingly presented yet potentially harmful cGPT to test safety features.

Results: We analyzed 22 ophthalmic cGPTs, of which 55% were for general use and the most common subspecialty was glaucoma (18%). Over half (55%) contained knowledge other than GPT-4 training data. The representation of the instructions through the description was between "Moderately representative" and "Very representative" with a median Likert score of 3.5 (IQR 3.0-4.0). The instruction word count was significantly associated with Likert scores (P = 0.03). Tested cGPTs demonstrated potential for specific conversational tone, information, retrieval and combining knowledge from an uploaded source. With these safety settings, creating a malicious GPT was possible.

Conclusions: This is the first study to our knowledge to examine the GPT store for a medical field. Our findings suggest that these cGPTs can be immediately implemented in practice and may offer more targeted and effective solutions compared to the standard GPT-4. However, further research is necessary to evaluate their capabilities and limitations comprehensively. The safety features currently appear to be rather limited. It may be helpful for the user to review the instruction section before using a cGPT.

导言:OpenAI 最近推出了一种功能,即利用基于文本的指令和/或外部文档,使用检索增强生成(RAG)架构创建自定义生成预训练变换器(cGPT),而无需编码知识。本研究旨在分析眼科相关 cGPT 的特点,并探索其潜在的实用性:数据收集工作于 2024 年 1 月 20 日和 21 日进行,通过在网站的 "探索 GPTS "部分输入眼科关键词找到定制的 GPT。记录了 cGPT 的一般特征和具体特征,如 GPT-4 培训数据以外的知识。我们使用李克特量表分析了说明和描述部分的兼容性。我们对 Likert 分数最高的两个定制 GPT 进行了详细分析。我们试图创建一个令人信服的、但可能有害的 cGPT 来测试安全性:我们分析了 22 份眼科 cGPT,其中 55% 为一般用途,最常见的亚专业是青光眼(18%)。半数以上(55%)包含 GPT-4 训练数据以外的知识。说明的代表性介于 "较有代表性 "和 "非常有代表性 "之间,李克特评分中位数为 3.5(IQR 3.0-4.0)。说明字数与 Likert 分数有明显相关性(P = 0.03)。经过测试的 cGPT 展示了特定对话语气、信息、检索和组合上传源知识的潜力。通过这些安全设置,创建恶意 GPT 是可能的:据我们所知,这是第一项检查医疗领域 GPT 商店的研究。我们的研究结果表明,这些 cGPT 可以立即在实践中实施,而且与标准 GPT-4 相比,可以提供更有针对性和更有效的解决方案。不过,要全面评估它们的能力和局限性,还需要进一步的研究。目前,安全功能似乎相当有限。用户在使用 cGPT 之前,最好先阅读一下说明部分。
{"title":"Exploring the Potential of Code-Free Custom GPTs in Ophthalmology: An Early Analysis of GPT Store and User-Creator Guidance.","authors":"Aslan Aykut, Almila Sarigul Sezenoz","doi":"10.1007/s40123-024-01014-w","DOIUrl":"10.1007/s40123-024-01014-w","url":null,"abstract":"<p><strong>Introduction: </strong>OpenAI recently introduced the ability to create custom generative pre-trained transformers (cGPTs) using text-based instruction and/or external documents using retrieval-augmented generation (RAG) architecture without coding knowledge. This study aimed to analyze the features of ophthalmology-related cGPTs and explore their potential utilities.</p><p><strong>Methods: </strong>Data collection took place on January 20 and 21, 2024, and custom GPTs were found by entering ophthalmology keywords into the \"Explore GPTS\" section of the website. General and specific features of cGPTs were recorded, such as knowledge other than GPT-4 training data. The instruction and description sections were analyzed for compatibility using the Likert scale. We analyzed two custom GPTs with the highest Likert score in detail. We attempted to create a convincingly presented yet potentially harmful cGPT to test safety features.</p><p><strong>Results: </strong>We analyzed 22 ophthalmic cGPTs, of which 55% were for general use and the most common subspecialty was glaucoma (18%). Over half (55%) contained knowledge other than GPT-4 training data. The representation of the instructions through the description was between \"Moderately representative\" and \"Very representative\" with a median Likert score of 3.5 (IQR 3.0-4.0). The instruction word count was significantly associated with Likert scores (P = 0.03). Tested cGPTs demonstrated potential for specific conversational tone, information, retrieval and combining knowledge from an uploaded source. With these safety settings, creating a malicious GPT was possible.</p><p><strong>Conclusions: </strong>This is the first study to our knowledge to examine the GPT store for a medical field. Our findings suggest that these cGPTs can be immediately implemented in practice and may offer more targeted and effective solutions compared to the standard GPT-4. However, further research is necessary to evaluate their capabilities and limitations comprehensively. The safety features currently appear to be rather limited. It may be helpful for the user to review the instruction section before using a cGPT.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"2697-2713"},"PeriodicalIF":2.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11408450/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141976294","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}
引用次数: 0
Progressive Thickening of Retinal Nerve Fiber and Ganglion Cell Complex Layers Following SDM Laser Vision Protection Therapy in Open-Angle Glaucoma 开角型青光眼患者接受 SDM 激光视力保护疗法后视网膜神经纤维和神经节细胞复合层逐渐增厚
IF 3.3 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-09-19 DOI: 10.1007/s40123-024-01029-3
Jeffrey K. Luttrull, Radouil Tzekov, Sathy V. Bhavan

Introduction

This work aims to determine the effect on nerve fiber layer (NFL) and ganglion cell complex (GCC) thickness trends in eyes with open-angle glaucoma (OAG) treated with Vision Protection Therapy™ (VPT).

Methods

A retrospective analysis of spectral-domain optical coherence tomography (OCT) measured NFL and GCC thickness trends was performed, excluding eyes with poor-quality scans and principal diagnoses other than OAG. This study compares eyes with OAG managed conventionally with IOP control alone (controls) to eyes managed with the addition of VPT (VPT eyes). The direction (+ or −) and magnitude (microns/year) of the OCT trends were the study endpoints.

Results

Seventy-eight control eyes of 40 patients and 61 VPT-treated eyes of 39 patients were included in the study. Positive NFL trends were noted in 5% of control eyes vs. 71% of VPT eyes (p < 0.0001). Positive GCC trends were noted in 8% of control eyes vs. 43% of VPT eyes (p < 0.0001). Mean NFL trends (µm/year) were − 0.692 for controls vs. 0.347 for VPT (p < 0.0001). Mean GCC trends (µm/year) were − 0.554 for controls vs. − 0.148 for VPT (p = 0.0175).

Conclusions

The addition of VPT to the conventional management of OAG resulted in highly significant improvements in NFL and GCC trends, indicating a reversal of key indicators of glaucoma severity and progression.

方法 对光谱域光学相干断层扫描 (OCT) 测得的神经纤维层 (NFL) 和神经节细胞复合体 (GCC) 厚度趋势进行回顾性分析,排除扫描质量差和主要诊断为 OAG 以外的眼。本研究比较了仅通过控制眼压进行常规治疗的 OAG 患眼(对照组)和通过加用 VPT 进行治疗的患眼(VPT 患眼)。OCT趋势的方向(+或-)和幅度(微米/年)是研究的终点。结果研究纳入了 40 名患者的 78 只对照眼和 39 名患者的 61 只接受过 VPT 治疗的眼。5%的对照眼和 71% 的 VPT 治疗眼出现了 NFL 阳性趋势(p < 0.0001)。8%的对照组眼球与 43% 的 VPT 眼球相比,GCC 呈阳性趋势(p < 0.0001)。对照组的平均 NFL 趋势(µm/年)为 - 0.692,而 VPT 为 0.347(p < 0.0001)。结论在 OAG 的常规治疗中加入 VPT,可显著改善 NFL 和 GCC 的趋势,表明青光眼严重程度和进展的关键指标发生了逆转。
{"title":"Progressive Thickening of Retinal Nerve Fiber and Ganglion Cell Complex Layers Following SDM Laser Vision Protection Therapy in Open-Angle Glaucoma","authors":"Jeffrey K. Luttrull, Radouil Tzekov, Sathy V. Bhavan","doi":"10.1007/s40123-024-01029-3","DOIUrl":"https://doi.org/10.1007/s40123-024-01029-3","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>This work aims to determine the effect on nerve fiber layer (NFL) and ganglion cell complex (GCC) thickness trends in eyes with open-angle glaucoma (OAG) treated with Vision Protection Therapy™ (VPT).</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>A retrospective analysis of spectral-domain optical coherence tomography (OCT) measured NFL and GCC thickness trends was performed, excluding eyes with poor-quality scans and principal diagnoses other than OAG. This study compares eyes with OAG managed conventionally with IOP control alone (controls) to eyes managed with the addition of VPT (VPT eyes). The direction (+ or −) and magnitude (microns/year) of the OCT trends were the study endpoints.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Seventy-eight control eyes of 40 patients and 61 VPT-treated eyes of 39 patients were included in the study. Positive NFL trends were noted in 5% of control eyes vs. 71% of VPT eyes (<i>p</i> &lt; 0.0001). Positive GCC trends were noted in 8% of control eyes vs. 43% of VPT eyes (<i>p</i> &lt; 0.0001). Mean NFL trends (µm/year) were − 0.692 for controls vs. 0.347 for VPT (<i>p</i> &lt; 0.0001). Mean GCC trends (µm/year) were − 0.554 for controls vs. − 0.148 for VPT (<i>p</i> = 0.0175).</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>The addition of VPT to the conventional management of OAG resulted in highly significant improvements in NFL and GCC trends, indicating a reversal of key indicators of glaucoma severity and progression.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":"39 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142260031","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Factors Influencing Treatment Preference in Patients with Diabetic Macular Edema: A Study Using Conjoint Analysis 影响糖尿病黄斑水肿患者治疗偏好的因素:联合分析法研究
IF 3.3 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-09-17 DOI: 10.1007/s40123-024-01026-6
Takao Hirano, Koji Tanabe, Toshinori Murata

Introduction

Despite the wide range of treatment options available for diabetic macular edema (DME), adherence to treatment remains a barrier. Therefore, this study used conjoint analysis to examine the factors that patients with DME prioritize when choosing a course of treatment and investigated differences in quality of life and levels of disease self-management in patients with or without experience of anti-vascular endothelial growth factor (VEGF) treatment.

Methods

A cross-sectional study was conducted through an online survey in Japan between May 31, 2022, and June 30, 2022. Questionnaires were sent to 27,236 individuals registered in the diabetes panels, with experience of treatment for DME within the last 10 years. Conjoint analysis was employed to calculate the relative importance, i.e., degree of influence on patients' treatment choices, considering the trade-offs among five factors: cost per treatment, frequency of visits, anticipated post-treatment visual acuity, physician’s explanation about disease and treatment, and frequency of treatment-related side effects.

Results

A total of 237 responses were used to assess the relative importance of cost per treatment, frequency of visits, anticipated post-treatment visual acuity, physician’s explanation about the disease, treatment, and frequency of treatment-related side effects using conjoint analysis. The importance of each factor was anticipated post-treatment visual acuity at 30.0, frequency of treatment-related side effects at 25.5, treatment frequency at 17.7, cost per treatment at 16.5, and physician explanation about the disease and treatment at 10.4. The average EuroQoL 5 dimension 5 level index value in patients with and without anti-VEGF treatment experience was 0.785 and 0.825, respectively, with no major difference.

Conclusions

Anticipated post-treatment visual acuity was identified as the most important factor in selecting a treatment regardless of the anti-vascular endothelial growth factor treatment experience demonstrating when patients with DME make treatment choices, anticipated post-treatment visual acuity is prioritized over treatment frequency and cost.

导言尽管糖尿病黄斑水肿(DME)的治疗方案多种多样,但坚持治疗仍然是一个障碍。因此,本研究采用联合分析法研究了 DME 患者在选择治疗方案时优先考虑的因素,并调查了有无抗血管内皮生长因子(VEGF)治疗经历的患者在生活质量和疾病自我管理水平方面的差异。方法在 2022 年 5 月 31 日至 2022 年 6 月 30 日期间,通过在线调查在日本开展了一项横断面研究。调查对象为 27,236 名糖尿病患者,这些患者在过去 10 年中接受过 DME 治疗。采用联合分析法计算了相对重要性,即对患者治疗选择的影响程度,同时考虑了以下五个因素之间的权衡:每次治疗费用、就诊频率、治疗后预期视力、医生对疾病和治疗的解释以及治疗相关副作用的频率。各因素的重要性分别为:治疗后预期视力为 30.0,治疗相关副作用频率为 25.5,治疗频率为 17.7,每次治疗费用为 16.5,医生对疾病和治疗的解释为 10.4。结论无论是否有抗血管内皮生长因子治疗经验,预期治疗后视力都被认为是选择治疗方法的最重要因素,这表明当 DME 患者选择治疗方法时,预期治疗后视力优先于治疗频率和费用。
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引用次数: 0
The I-OPTA Questionnaire: A National Assessment of Patients with Neovascular Age-Related Macular Degeneration I-OPTA 问卷:对新生血管性老年黄斑变性患者进行全国性评估
IF 3.3 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-09-16 DOI: 10.1007/s40123-024-01028-4
Benjamin Sommer Thinggaard, Kasper Hansen, Freja Dinesen, Maria Kjøller Pedersen, Lars Morsø, Yousif Subhi, Jakob Grauslund, Lonny Stokholm

Introduction

Neovascular age-related macular degeneration (nAMD) is the leading cause of irreversible vision loss in developed countries. However, a significant gap persists in understanding this population, exacerbated by their advanced age and visual impairments, which can hinder research participation and access to healthcare. The purpose of this study was to describe the content of the questionnaire and the participating patients with nAMD.

Methods

The survey includes patients diagnosed with nAMD who had previously received treatment or were currently undergoing intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections. Participants were recruited using various methods, as reaching out to patients who are no longer receiving treatment poses a particular challenge. A patient and public advisory board assisted throughout the study period.

Results

Of the 713 electronic invitations sent out, 494 (69.3%) patients responded to the questionnaire, with an additional 57 responses obtained through e-mail or telephone interviews. Due to the exclusion of 16 responses, there were a total of 535 valid responses, including 176 from patients previously treated and 359 from those currently undergoing treatment for nAMD. The median age of respondents was 79.9 years (interquartile range [IQR] 75.5–84.7), with 59.8% being women. Among them, 53.2% were married, while 43.1% lived alone.

Conclusions

Data from the I-OPTA (Identification of Patient-Reported Barriers in Treatment for nAMD) questionnaire allows future exploration of patients who are no longer receiving treatment, patients’ knowledge about preventive measures, and the impact of nAMD on visual function and quality of life. Future research, including studies that integrate data from corresponding retinal images and Danish national registers, has the potential to generate invaluable knowledge, providing benefits to both patients and healthcare professionals.

导言在发达国家,血管性老年黄斑变性(nAMD)是导致不可逆视力丧失的主要原因。然而,人们对这一人群的了解仍存在很大差距,他们的高龄和视力障碍更加剧了这一差距,这可能会阻碍他们参与研究和获得医疗服务。本研究的目的是描述调查问卷的内容和参与调查的 nAMD 患者。方法调查对象包括确诊为 nAMD 的患者,他们曾接受过治疗或正在接受玻璃体内抗血管内皮生长因子 (anti-VEGF) 注射。由于接触不再接受治疗的患者是一项特殊的挑战,因此采用了多种方法招募参与者。在发出的 713 份电子邀请函中,有 494 名(69.3%)患者回复了问卷,另有 57 名患者通过电子邮件或电话访谈回复了问卷。由于排除了 16 份回复,有效回复共有 535 份,其中 176 份来自曾经接受过治疗的患者,359 份来自目前正在接受 nAMD 治疗的患者。受访者的年龄中位数为 79.9 岁(四分位数间距 [IQR] 75.5-84.7),59.8% 为女性。结论 I-OPTA(患者报告的 nAMD 治疗障碍识别)调查问卷的数据有助于今后对不再接受治疗的患者、患者对预防措施的了解以及 nAMD 对视觉功能和生活质量的影响进行探讨。未来的研究,包括整合相应视网膜图像和丹麦国家登记册数据的研究,有可能产生宝贵的知识,为患者和医疗保健专业人员带来益处。
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引用次数: 0
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Ophthalmology and Therapy
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