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Safety and Efficacy of Multiple Escalating Doses of RC28-E for Neovascular Age-Related Macular Degeneration: A Phase 1b Trial. 多剂量递增的 RC28-E 治疗新生血管性老年黄斑变性的安全性和有效性:1b期试验。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-09-01 Epub Date: 2024-07-20 DOI: 10.1007/s40123-024-00994-z
Yingyi Lu, Xiaobing Yu, Youxin Chen, Chan Wu, Qin Jiang, Shaoping Ha, Dan Zhu, Yanlong Bi, Xiaoling Liu, Han Zhang, Zhuo Li, Wenxiang Wang, Lin Li, He Chen, Yifan Zhang, Hong Dai, Jianmin Fang

Introduction: To assess the safety and efficacy of repeated intravitreal injections of RC28-E, a novel bispecific antibody that simultaneously binds vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) in patients with neovascular age-related macular degeneration (AMD). This was a prospective, multicenter, open-label clinical trial; 37 patients with choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) letter scores between 73 and 34 were enrolled.

Methods: Treatment regimens consisted of a 3-month loading phase and a pro re nata (PRN) maintenance phase. This study included three treatment groups: the 0.5, 1.0, and 2.0 mg RC28-E groups, with escalating doses ranging from 0.5 to 2.0 mg. Patients were evaluated monthly for 48 weeks. Safety was assessed based on ocular and systemic adverse events (AEs), pharmacokinetic characteristics, and the presence of anti-RC28-E antibodies. Efficacy was assessed using the mean change in BCVA and central subfield thickness (CST) from baseline to week 48.

Results: Most AEs were mild or moderate. The most common AE was a minor injection-related subconjunctival hemorrhage (16.2%). The AEs did not increase with dose or repeated injections. At week 48, mean improvements in BCVA from baseline in the 0.5, 1.0, and 2.0 mg groups were 6.1 ± 8.3, 9.9 ± 10.7, and 7.6 ± 9.38 letters, respectively; mean reductions in CST in the three groups were 112.1 ± 160.5, 175.1 ± 212.4, and 128.7 ± 145.8 μm, respectively. The serum RC28-E concentrations in 95% of the patients were below the quantification limit of the assay. No significant change from baseline was observed in the mean plasma concentrations of VEGF or FGF over the 48 weeks of treatment. Pre-treatment antibodies to RC28-E were detected in 1 of the 37 patients. Antibodies to RC28-E were detected in two patients after dosing with RC28-E for 48 weeks.

Conclusion: RC28-E was well tolerated and exhibited an overall favorable safety profile with evidence of improvements in BCVA and anatomical parameters.

简介RC28-E是一种新型双特异性抗体,能同时与血管内皮生长因子(VEGF)和碱性成纤维细胞生长因子(bFGF)结合,目的是评估在新生血管性老年性黄斑变性(AMD)患者中重复玻璃体内注射RC28-E的安全性和有效性。这是一项前瞻性、多中心、开放标签临床试验;37 名继发于 AMD 的脉络膜新生血管患者入选,其最佳矫正视力(BCVA)字母评分在 73 到 34 之间:治疗方案包括为期 3 个月的负荷期和按时(PRN)维持期。该研究包括三个治疗组:0.5、1.0 和 2.0 毫克 RC28-E 组,剂量从 0.5 毫克递增到 2.0 毫克。患者每月接受一次评估,为期 48 周。安全性根据眼部和全身不良事件(AE)、药代动力学特征以及是否存在抗RC28-E抗体进行评估。疗效根据 BCVA 和中央子场厚度(CST)从基线到第 48 周的平均变化进行评估:大多数不良反应为轻度或中度。最常见的不良反应是轻微的注射相关结膜下出血(16.2%)。这些不良反应并不随剂量或重复注射而增加。第48周时,0.5、1.0和2.0毫克组BCVA较基线的平均改善幅度分别为6.1±8.3、9.9±10.7和7.6±9.38个字母;三组CST的平均降低幅度分别为112.1±160.5、175.1±212.4和128.7±145.8微米。95% 患者的血清 RC28-E 浓度低于检测的定量限。在48周的治疗过程中,VEGF或FGF的平均血浆浓度与基线相比没有明显变化。37名患者中有1名患者在治疗前检测到了RC28-E抗体。结论:RC28-E的耐受性良好:结论:RC28-E的耐受性良好,总体安全性良好,有证据表明BCVA和解剖参数有所改善。
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引用次数: 0
Efficacy and Safety of Preoperative Prophylaxis in Cataract Surgery with Combined Topical Antiseptics: A Microbiological Study. 白内障手术术前预防联合局部抗菌剂的有效性和安全性:微生物学研究。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-09-01 Epub Date: 2024-07-24 DOI: 10.1007/s40123-024-01000-2
Rocco Luigi Modugno, Adriano Fasolo, Davide Camposampiero, Diego Ponzin, Marco Tavolato

Introduction: To evaluate the antimicrobial efficacy of an ophthalmic formulation containing hexamidine diisethionate (HD) 0.05%, polyhexamethylene biguanide (PHMB) 0.0001%, and edetate disodium (EDTA) 0.01% (Keratosept®, Bruschettini, Genova, Italy) on the microbial flora of a healthy ocular surface.

Methods: Patients were enrolled consecutively. Each patient applied two drops of Keratosept® in the eye scheduled for cataract surgery (study eye) three times daily in the 2 days prior to surgery and one time in the morning of surgery. The contralateral eyes were considered as control (control eye). Bilateral conjunctival swabs were collected before the first administration (T0) and the morning of surgery (T1). The swabs were processed within 3 h from sampling for the automated detection of the presence of replicating microorganisms (colony-forming units, CFU/mL) and the provision of real-time growth curves.

Results: Conjunctival swabs of 32 patients (n = 128) were examined. Six patients were excluded from the efficacy analysis because of microbial load < 50 CFU/mL at T0 in the study eye. No difference between study and control eyes was observed at T0 (p = 0.40). Compared with T0, 20 (76.9%) study eyes and 10 (38.5%) control eyes showed a ≥ 1 log reduction of the microbial load at T1, with a significant difference between groups (p = 0.005). Keratosept® showed good tolerability, and no adverse events or eye discomfort were recorded.

Conclusions: This study showed that the low-dose combination of antiseptic agents in the Keratosept® ophthalmic solution effectively reduces the bacterial load of healthy flora on the ocular surface.

简介目的:评估一种含有 0.05% 二硫酸己脒 (HD)、0.0001% 聚六亚甲基双胍 (PHMB) 和 0.01% 乙二胺四乙酸二钠 (EDTA) 的眼科制剂(Keratosept®,意大利 Genova Bruschettini 公司)对健康眼表微生物菌群的抗菌效果:方法:连续招募患者。每位患者在计划接受白内障手术的眼睛(研究眼)滴两滴 Keratosept® ,手术前两天每天滴三次,手术当天早上滴一次。对侧眼睛作为对照(对照眼)。在首次用药前(T0)和手术当天早上(T1)收集双侧结膜拭子。在取样后 3 小时内处理拭子,以自动检测是否存在复制微生物(菌落形成单位,CFU/mL),并提供实时生长曲线:检查了 32 名患者(n = 128)的结膜拭子。6名患者因微生物负荷而被排除在疗效分析之外:这项研究表明,Keratosept® 眼科溶液中的低剂量复合杀菌剂能有效减少眼表健康菌群的细菌负荷。
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引用次数: 0
A Response to: Letter to the Editor Regarding an Emerging Ophthalmology Challenge: A Narrative Review of TikTok Trends Impacting Eye Health Among Children and Adolescents. 回应:致编辑的一封信:眼科新挑战:关于影响儿童和青少年眼健康的 TikTok 趋势的叙述性评论。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-09-01 Epub Date: 2024-07-08 DOI: 10.1007/s40123-024-00990-3
Sally Al Hassan, Alaa Bou Ghannam, Joanna S Saade
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引用次数: 0
Systematic Literature Reviews Comparing the Long-Term Safety Outcomes for the Port Delivery System with Ranibizumab (PDS) Versus Other Ocular Implants. 系统性文献综述:比较拉尼珠单抗孔道给药系统 (PDS) 与其他眼部植入物的长期安全性结果。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-09-01 Epub Date: 2024-08-01 DOI: 10.1007/s40123-024-01001-1
Nancy M Holekamp, Manejeh Yaqub, Shrirang V Ranade, Ronald A Cantrell, Sheena Singh, Gus Gazzard

Objectives: To determine whether the types and rates of post-surgical complications associated with the Port Delivery System with ranibizumab (PDS) are comparable with those reported for other ocular implants that cross the sclera.

Methods: Systematic literature reviews were conducted to determine the long-term (≥ 18-month) safety of ocular implants that cross the sclera in clinical trials and real-world studies. Complication types and rates were compared with those reported for the PDS in phase III clinical trials (Archway, Pagoda, and Pavilion).

Results: Sixteen clinical trials (24 publications) and 43 real-world studies were identified reporting 30 complications in eyes with 15 implant types and 8 ocular diseases. Implants were associated with an acceptable, well-characterized safety profile, with most complications resolving spontaneously or with treatment. Device-related complications were reported in 0.7% (0.0-5.0%) of study eyes in clinical trials and 1.3% (0.0-14.5%) of eyes in real-world studies. Rates of conjunctival complications were 2.1% (0.0-22.8%) and 2.2% (0.9-4.6%), respectively. The overall types and rates of adverse events of special interest reported for the PDS in phase III trials (cataract, conjunctival bleb, vitreous hemorrhage, conjunctival erosion, conjunctival retraction, endophthalmitis, implant dislocation, retinal detachment, and hyphema) were within the ranges reported for other ocular implants.

Conclusions: The rates of complications reported in phase III clinical trials for the PDS were within the ranges reported for other ocular implants that cross the sclera. This suggests that the long-term safety of the PDS is consistent with other ocular devices established in ophthalmology clinical practice.

Trial registration: PROSPERO international prospective register of systematic reviews: CRD5202234129, CRD42022343129.

目的确定使用雷尼珠单抗的孔道给药系统(PDS)的术后并发症类型和发生率是否与其他穿过巩膜的眼科植入物的并发症类型和发生率相当:方法:我们进行了系统的文献综述,以确定临床试验和实际研究中穿过巩膜的眼科植入物的长期(≥ 18 个月)安全性。将并发症类型和发生率与 III 期临床试验(Archway、Pagoda 和 Pavilion)中报告的 PDS 并发症类型和发生率进行比较:结果:共发现 16 项临床试验(24 篇论文)和 43 项实际研究,报告了 15 种植入物和 8 种眼部疾病的 30 种并发症。植入物具有可接受的、特征明确的安全性,大多数并发症可自行缓解或经治疗后缓解。据报道,在临床试验中,0.7%(0.0-5.0%)的研究眼出现了与设备相关的并发症,在实际研究中,1.3%(0.0-14.5%)的研究眼出现了与设备相关的并发症。结膜并发症的发生率分别为 2.1%(0.0-22.8%)和 2.2%(0.9-4.6%)。PDS在III期试验中报告的特别关注的不良事件(白内障、结膜出血、玻璃体出血、结膜糜烂、结膜回缩、眼底病、植入物脱位、视网膜脱离和红斑)的总体类型和发生率与其他眼科植入物报告的范围一致:结论:PDS III 期临床试验中报告的并发症发生率与其他穿过巩膜的眼球植入物的并发症发生率在同一范围内。这表明,PDS 的长期安全性与眼科临床实践中使用的其他眼科植入物是一致的:试验注册:PROSPERO 国际前瞻性系统综述注册:CRD5202234129、CRD42022343129。
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引用次数: 0
Detection of Subclinical Neurotrophic Keratopathy by Noncontact Esthesiometry. 用非接触式测色法检测亚临床神经营养性角膜病变
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-09-01 Epub Date: 2024-07-19 DOI: 10.1007/s40123-024-00998-9
Marta Villalba, Victor Sabates, Sarp Orgul, Victor L Perez, Swarup S Swaminathan, Alfonso L Sabater

Introduction: This study aimed to analyze corneal sensitivity with a new noncontact and handheld esthesiometer (Brill Engines, Spain) in patients with dry eye disease (DED) and patients on hypotensive drops, and to compare it with healthy subjects.

Methods: A total of 31 patients (57 eyes) with DED, 23 patients (46 eyes) with glaucoma, and 21 healthy patients (33 eyes) were recruited. In all patients, corneal sensitivity was measured. Subsequently, a keratography test (Keratograph 5M, Oculus) was carried out to measure tear meniscus height (TMH), non-invasive breakup time (NIBUT), bulbar redness (Jenvis scale), and corneal staining (CS, Oxford scale). Both corneal sensitivity and ocular surface parameters were compared between DED, glaucoma, and healthy subjects. Linear mixed models were constructed to utilize data from both eyes of patients. An alpha level of 0.05 was considered statistically significant.

Results: The mean age was 56.1 ± 16.1 years in the DED group, 69.5 ± 11.7 years in the glaucoma group, and 37.190 ± 11.677 years in the control group. After adjustment for age and sex, corneal sensitivity was significantly reduced in DED and glaucoma vs control group (P = 0.02 and P = 0.009, respectively). NIBUT was lower in DED and glaucoma groups (P < 0.001 and P = 0.001, respectively). Redness and CS values were higher in the DED group (P = 0.04 and P = 0.001, respectively). TMH was lower in the glaucoma group (P = 0.03).

Conclusions: Corneal sensitivity measured with a novel noncontact esthesiometer was reduced in DED and glaucoma groups compared to controls. In clinical practice, this esthesiometer could be an easy-to-use device to screen for patients with subclinical neurotrophic keratopathy.

前言:本研究旨在使用新型非接触式手持角膜曲率计(Brill Engines,西班牙)分析干眼症(DED)患者和滴用降眼压药水患者的角膜敏感度,并与健康受试者进行比较:共招募了 31 名 DED 患者(57 只眼睛)、23 名青光眼患者(46 只眼睛)和 21 名健康患者(33 只眼睛)。对所有患者的角膜敏感度进行了测量。随后,进行了角膜成像测试(Keratograph 5M,Oculus),以测量泪液半月板高度(TMH)、无创泪液破裂时间(NIBUT)、球红(Jenvis 量表)和角膜染色(CS,牛津量表)。对 DED、青光眼和健康受试者的角膜敏感性和眼表参数进行了比较。利用患者双眼的数据构建了线性混合模型。0.05的α水平被认为具有统计学意义:DED组的平均年龄为(56.1 ± 16.1)岁,青光眼组为(69.5 ± 11.7)岁,对照组为(37.190 ± 11.677)岁。对年龄和性别进行调整后,DED 组和青光眼组与对照组相比,角膜敏感度明显降低(分别为 P = 0.02 和 P = 0.009)。DED 组和青光眼组的 NIBUT 值更低(P 结论:DED 组和青光眼组的 NIBUT 值更低):与对照组相比,使用新型非接触式眼压计测量的 DED 组和青光眼组角膜敏感度降低。在临床实践中,这种角膜曲率计可作为一种易于使用的设备,用于筛查亚临床神经营养性角膜病变患者。
{"title":"Detection of Subclinical Neurotrophic Keratopathy by Noncontact Esthesiometry.","authors":"Marta Villalba, Victor Sabates, Sarp Orgul, Victor L Perez, Swarup S Swaminathan, Alfonso L Sabater","doi":"10.1007/s40123-024-00998-9","DOIUrl":"10.1007/s40123-024-00998-9","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to analyze corneal sensitivity with a new noncontact and handheld esthesiometer (Brill Engines, Spain) in patients with dry eye disease (DED) and patients on hypotensive drops, and to compare it with healthy subjects.</p><p><strong>Methods: </strong>A total of 31 patients (57 eyes) with DED, 23 patients (46 eyes) with glaucoma, and 21 healthy patients (33 eyes) were recruited. In all patients, corneal sensitivity was measured. Subsequently, a keratography test (Keratograph 5M, Oculus) was carried out to measure tear meniscus height (TMH), non-invasive breakup time (NIBUT), bulbar redness (Jenvis scale), and corneal staining (CS, Oxford scale). Both corneal sensitivity and ocular surface parameters were compared between DED, glaucoma, and healthy subjects. Linear mixed models were constructed to utilize data from both eyes of patients. An alpha level of 0.05 was considered statistically significant.</p><p><strong>Results: </strong>The mean age was 56.1 ± 16.1 years in the DED group, 69.5 ± 11.7 years in the glaucoma group, and 37.190 ± 11.677 years in the control group. After adjustment for age and sex, corneal sensitivity was significantly reduced in DED and glaucoma vs control group (P = 0.02 and P = 0.009, respectively). NIBUT was lower in DED and glaucoma groups (P < 0.001 and P = 0.001, respectively). Redness and CS values were higher in the DED group (P = 0.04 and P = 0.001, respectively). TMH was lower in the glaucoma group (P = 0.03).</p><p><strong>Conclusions: </strong>Corneal sensitivity measured with a novel noncontact esthesiometer was reduced in DED and glaucoma groups compared to controls. In clinical practice, this esthesiometer could be an easy-to-use device to screen for patients with subclinical neurotrophic keratopathy.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"2393-2404"},"PeriodicalIF":2.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11341800/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141724115","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
Platelet-rich Fibrin Membrane Transplantation for the Treatment of Highly Myopic Macular Hole Retinal Detachment. 富血小板纤维蛋白膜移植治疗高度近视黄斑孔视网膜脱离。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-09-01 Epub Date: 2024-07-26 DOI: 10.1007/s40123-024-00997-w
Guojing Lu, Siyu Zeng, Rong Huang, Lei Du

Introduction: Highly myopic macular hole retinal detachment (MHRD) is often associated with a poor prognosis, and there is currently no optimal treatment. Platelet-rich fibrin (PRF), an autologous blood product, has been shown to promote tissue regeneration. This prospective, randomized, controlled study investigated the efficacy of conventional internal limiting membrane (ILM) peeling versus PRF membrane transplantation in highly myopic MHRD.

Methods: Eyes with highly myopic MHRD were randomly assigned to either a conventional ILM peeling group (IP group, n = 19) or a PRF membrane transplantation group (PMT group, n = 21). The study followed participants for a period of 6 months. The primary outcome measure was macular hole (MH) closure assessed using optical coherence tomography. Secondary outcomes included best-corrected visual acuity (BCVA), central retinal thickness (CRT), superficial vascular density (SVD), deep vascular density (DVD), rate of retinal reattachment, and any complications encountered.

Results: MH closure was achieved in a significantly greater proportion of eyes in the PMT group (21/21, 100.00%) compared to the IP group (15/19, 78.95%) (P = 0.042). Retinal reattachment was accomplished in all patients (100.00%) within both groups. Except for an insignificant difference in BCVA observed at 1 week post-surgery in the IP group, significant improvements in BCVA and CRT were documented in both groups across all other post-operative time points. Final BCVA (P = 0.040), CRT (P = 0.002), SVD (P = 0.002), and DVD (P = 0.013) were all significantly higher in the PMT group compared to the IP group. No serious complications were identified in either group.

Conclusions: This study demonstrated the superiority of PRF membrane transplantation compared to conventional ILM peeling in promoting MH closure and enhancing retinal vascular density in patients with highly myopic MHRD. Additionally, PRF membrane transplantation effectively restores retinal reattachment, improves visual function, and increases retinal thickness without introducing additional complications.

Trial registration number: www.

Clinicaltrials: gov , NCT06200727.

简介高度近视黄斑孔视网膜脱离(MHRD)通常预后不良,目前尚无最佳治疗方法。富血小板纤维蛋白(PRF)是一种自体血液制品,已被证明能促进组织再生。这项前瞻性、随机对照研究调查了传统内层限局性膜(ILM)剥离术与富血小板纤维蛋白膜移植术对高度近视 MHRD 的疗效:高度近视 MHRD 患者被随机分配到传统内层限界膜剥离组(IP 组,n = 19)或 PRF 膜移植组(PMT 组,n = 21)。研究对参与者进行了为期 6 个月的随访。主要结果是使用光学相干断层扫描评估黄斑孔(MH)闭合情况。次要结果包括最佳矫正视力(BCVA)、视网膜中央厚度(CRT)、浅层血管密度(SVD)、深层血管密度(DVD)、视网膜再粘连率以及遇到的任何并发症:PMT组实现MH闭合的比例(21/21,100.00%)明显高于IP组(15/19,78.95%)(P = 0.042)。两组所有患者(100.00%)都完成了视网膜再接。除了 IP 组术后 1 周 BCVA 的差异不显著外,两组患者在术后所有其他时间点的 BCVA 和 CRT 均有显著改善。与 IP 组相比,PMT 组的最终 BCVA(P = 0.040)、CRT(P = 0.002)、SVD(P = 0.002)和 DVD(P = 0.013)均显著提高。两组均未发现严重并发症:本研究表明,与传统的ILM剥离相比,PRF膜移植在促进高度近视MHRD患者的MH闭合和提高视网膜血管密度方面更具优势。此外,PRF 膜移植能有效恢复视网膜重新附着,改善视功能,增加视网膜厚度,且不会带来额外的并发症。试验注册号:www.Clinicaltrials: gov , NCT06200727。
{"title":"Platelet-rich Fibrin Membrane Transplantation for the Treatment of Highly Myopic Macular Hole Retinal Detachment.","authors":"Guojing Lu, Siyu Zeng, Rong Huang, Lei Du","doi":"10.1007/s40123-024-00997-w","DOIUrl":"10.1007/s40123-024-00997-w","url":null,"abstract":"<p><strong>Introduction: </strong>Highly myopic macular hole retinal detachment (MHRD) is often associated with a poor prognosis, and there is currently no optimal treatment. Platelet-rich fibrin (PRF), an autologous blood product, has been shown to promote tissue regeneration. This prospective, randomized, controlled study investigated the efficacy of conventional internal limiting membrane (ILM) peeling versus PRF membrane transplantation in highly myopic MHRD.</p><p><strong>Methods: </strong>Eyes with highly myopic MHRD were randomly assigned to either a conventional ILM peeling group (IP group, n = 19) or a PRF membrane transplantation group (PMT group, n = 21). The study followed participants for a period of 6 months. The primary outcome measure was macular hole (MH) closure assessed using optical coherence tomography. Secondary outcomes included best-corrected visual acuity (BCVA), central retinal thickness (CRT), superficial vascular density (SVD), deep vascular density (DVD), rate of retinal reattachment, and any complications encountered.</p><p><strong>Results: </strong>MH closure was achieved in a significantly greater proportion of eyes in the PMT group (21/21, 100.00%) compared to the IP group (15/19, 78.95%) (P = 0.042). Retinal reattachment was accomplished in all patients (100.00%) within both groups. Except for an insignificant difference in BCVA observed at 1 week post-surgery in the IP group, significant improvements in BCVA and CRT were documented in both groups across all other post-operative time points. Final BCVA (P = 0.040), CRT (P = 0.002), SVD (P = 0.002), and DVD (P = 0.013) were all significantly higher in the PMT group compared to the IP group. No serious complications were identified in either group.</p><p><strong>Conclusions: </strong>This study demonstrated the superiority of PRF membrane transplantation compared to conventional ILM peeling in promoting MH closure and enhancing retinal vascular density in patients with highly myopic MHRD. Additionally, PRF membrane transplantation effectively restores retinal reattachment, improves visual function, and increases retinal thickness without introducing additional complications.</p><p><strong>Trial registration number: </strong>www.</p><p><strong>Clinicaltrials: </strong>gov , NCT06200727.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"2425-2443"},"PeriodicalIF":2.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11341796/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141767006","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
The Impact of the COVID-19 Pandemic on Tele-ophthalmology-Based Retinal Screening. COVID-19 大流行对远程眼科视网膜筛查的影响。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-09-01 Epub Date: 2024-08-02 DOI: 10.1007/s40123-024-01008-8
Marie L R Rasmussen, Lasse J Cehofski, Julie Davies, Carsten Faber, Mads K Falk, Jakob Grauslund, Michael S Hansen, Pearse A Keane, Sundaram Natarajan, Tunde Peto, Yousif Subhi, Charles C Wykoff, Danson V Muttuvelu

Introduction: This study reports our experiences with systematic retinal screening in Denmark through optometrists with access to tele-ophthalmological services before, during, and after the COVID-19 pandemic.

Methods: We evaluated an optometrist-based retinal screening system with a referral option for tele-ophthalmological service by a consultant ophthalmologist within the time period of August 1, 2018 to September 30, 2023. The optometrist collected patient history, refraction, best-corrected visual acuity, intraocular pressure, basic slit-lamp examination, 4-in-1 visual field report, and retinal imaging using color fundus 45° photography. Tele-ophthalmological services were provided by consultant ophthalmologists. Within pre-defined periods of pre-COVID-19, COVID-19, and post-COVID-19, we evaluated the rate of referrals to the tele-ophthalmological service, diagnoses made, and referrals to the public healthcare system.

Results: A total of 1,142,028 unique individuals, which corresponded to 19.1% of the entire population of Denmark, underwent screening by the optometrists; 50,612 (4.4%) of these individuals were referred to the tele-ophthalmological examination by consultant ophthalmologists. A referral for further ophthalmic examination, either at hospital or at an ophthalmic practice, was made for 10,300 individuals (20.4% of those referred for tele-ophthalmology, corresponding to 0.9% of the population screened). The referral rate from the screening to the tele-ophthalmological service increased from before COVID-19 (3.4%) to during COVID-19 (4.3%) and further after COVID-19 (6.4%). This increase coincided with an increasing prevalence of conditions seen in the tele-ophthalmological service.

Conclusion: During a period of 5 years, 19.1% of the entire population of Denmark underwent retinal screening. This provided an adjunctive health service during a period of severe strain on the public healthcare system, while limiting the number of excessive referrals to the public healthcare system. Temporal trends illustrated an increased pattern of use of a large-scale tele-ophthalmological system.

导言:本研究报告了在 COVID-19 大流行之前、期间和之后,丹麦通过验光师提供远程眼科服务进行系统性视网膜筛查的经验:我们评估了一个以视光师为基础的视网膜筛查系统,该系统在 2018 年 8 月 1 日至 2023 年 9 月 30 日期间可转诊至眼科顾问提供的远程眼科服务。验光师收集患者病史、屈光度、最佳矫正视力、眼压、基本裂隙灯检查、四合一视野报告,并使用彩色眼底 45° 摄影进行视网膜成像。远程眼科服务由眼科顾问提供。在 COVID-19 前、COVID-19 和 COVID-19 后的预定时间段内,我们对远程眼科服务的转诊率、诊断结果以及向公共医疗系统的转诊情况进行了评估:共有 1,142,028 人接受了验光师的筛查,占丹麦总人口的 19.1%;其中 50,612 人(4.4%)由眼科顾问转诊至远程眼科检查。有 10,300 人(占远程眼科检查转诊人数的 20.4%,相当于接受筛查人数的 0.9%)被转诊到医院或眼科诊所接受进一步眼科检查。从筛查到远程眼科服务的转诊率从 COVID-19 之前(3.4%)上升到 COVID-19 期间(4.3%)和 COVID-19 之后(6.4%)。这一增长与远程眼科服务的患病率上升相吻合:结论:5 年间,丹麦有 19.1% 的人口接受了视网膜筛查。这在公共医疗系统面临严重压力的时期提供了一项辅助医疗服务,同时限制了向公共医疗系统过度转诊的数量。时间趋势表明,大规模远程眼科系统的使用模式在不断增加。
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引用次数: 0
Travoprost Intracameral Implant Demonstrates Superior IOP Lowering Versus Topical Prostaglandin Analog Monotherapy in Patients with Open-Angle Glaucoma or Ocular Hypertension. 在开角型青光眼或眼压过高患者中,曲伏前列素巩膜内植入剂与局部前列腺素类似物单药治疗相比,具有更佳的降低眼压效果。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-09-01 Epub Date: 2024-07-10 DOI: 10.1007/s40123-024-00992-1
Jason Bacharach, Long V Doan, Kerry G Stephens, Dale W Usner, Angela C Kothe, L Jay Katz, Tomas Navratil

Introduction: This study was conducted to analyze and compare the intraocular pressure (IOP) treatment effect of the slow-eluting (SE) travoprost intracameral implant to the IOP treatment effect of topical prostaglandin analog (PGA) monotherapy in a subgroup of subjects who were on pre-study PGA monotherapy prior to enrollment in the two pivotal phase 3 trials of the travoprost intracameral implant.

Methods: A combined study population of 133 subjects from two phase 3 trials, who were on topical PGA monotherapy at screening, subsequently underwent a washout period from their topical PGA, and then were randomized and administered an SE travoprost intracameral implant. The subjects were analyzed for the IOP treatment effects of the pre-study topical PGA monotherapy and the in-study SE travoprost intracameral implant. Paired t-tests were used to compare the difference in screening minus post-washout baseline IOP versus month 3 minus post-washout baseline IOP. The IOP-lowering efficacy in eyes administered an SE travoprost intracameral implant was compared to the IOP lowering in the same eyes while on a topical PGA monotherapy prior to study entry.

Results: Pre-study topical PGA monotherapy and the SE travoprost intracameral implant demonstrated IOP treatment effects of -5.76 mmHg and -7.07 mmHg, respectively. The IOP-lowering treatment effect was significantly greater by 1.31 mmHg for the SE travoprost intracameral implant relative to pre-study PGA monotherapy (95% confidence interval: -2.01, -0.60; P = 0.0003).

Conclusions: The SE travoprost intracameral implant demonstrated superior IOP-lowering treatment effect versus pre-study topical PGA monotherapy with a superiority margin that was both statistically significant and clinically meaningful. The greater IOP reduction from baseline while on the SE implant versus pre-study topical PGA monotherapy may be a reflection of the optimized adherence and continuous elution of PGA therapy into the anterior chamber achieved with the SE travoprost intracameral implant.

Trial registration: ClinicalTrials.gov identifiers, NCT03519386 and NCT03868124.

导言:本研究旨在分析和比较慢洗脱(SE)曲伏前列素巩膜内植入剂与局部前列腺素类似物(PGA)单药治疗的眼压(IOP)治疗效果:两项三期试验中的133名受试者接受了联合研究,这些受试者在筛查时接受了局部PGA单药治疗,随后接受了局部PGA冲洗期,然后被随机分配并接受了SE曲伏前列素巩膜内植入治疗。研究人员分析了研究前局部 PGA 单药治疗和研究中 SE 曲伏前列素巩膜内植入治疗对受试者眼压的治疗效果。采用配对 t 检验比较筛选减去冲洗后基线 IOP 与第 3 个月减去冲洗后基线 IOP 的差异。将使用 SE 曲伏前列素巩膜内植入剂的眼睛的降眼压疗效与同一眼睛在进入研究前使用局部 PGA 单药治疗时的降眼压疗效进行比较:结果:研究前局部PGA单药治疗和SE曲伏前列素巩膜内植入剂的眼压治疗效果分别为-5.76 mmHg和-7.07 mmHg。与研究前的PGA单药治疗相比,SE曲伏前列素巩膜内植入剂的降眼压治疗效果显著提高了1.31 mmHg(95%置信区间:-2.01,-0.60;P = 0.0003):SE曲伏前列素巩膜内植入剂与研究前的局部PGA单药治疗相比,具有更优越的降眼压治疗效果,其优越性具有显著的统计学意义和临床意义。与研究前的局部 PGA 单一疗法相比,使用 SE 植入物时眼压从基线降低的幅度更大,这可能反映了 SE 曲伏前列素巩膜内植入物优化了依从性,并能将 PGA 治疗持续洗脱到前房:试验注册:ClinicalTrials.gov标识符NCT03519386和NCT03868124。
{"title":"Travoprost Intracameral Implant Demonstrates Superior IOP Lowering Versus Topical Prostaglandin Analog Monotherapy in Patients with Open-Angle Glaucoma or Ocular Hypertension.","authors":"Jason Bacharach, Long V Doan, Kerry G Stephens, Dale W Usner, Angela C Kothe, L Jay Katz, Tomas Navratil","doi":"10.1007/s40123-024-00992-1","DOIUrl":"10.1007/s40123-024-00992-1","url":null,"abstract":"<p><strong>Introduction: </strong>This study was conducted to analyze and compare the intraocular pressure (IOP) treatment effect of the slow-eluting (SE) travoprost intracameral implant to the IOP treatment effect of topical prostaglandin analog (PGA) monotherapy in a subgroup of subjects who were on pre-study PGA monotherapy prior to enrollment in the two pivotal phase 3 trials of the travoprost intracameral implant.</p><p><strong>Methods: </strong>A combined study population of 133 subjects from two phase 3 trials, who were on topical PGA monotherapy at screening, subsequently underwent a washout period from their topical PGA, and then were randomized and administered an SE travoprost intracameral implant. The subjects were analyzed for the IOP treatment effects of the pre-study topical PGA monotherapy and the in-study SE travoprost intracameral implant. Paired t-tests were used to compare the difference in screening minus post-washout baseline IOP versus month 3 minus post-washout baseline IOP. The IOP-lowering efficacy in eyes administered an SE travoprost intracameral implant was compared to the IOP lowering in the same eyes while on a topical PGA monotherapy prior to study entry.</p><p><strong>Results: </strong>Pre-study topical PGA monotherapy and the SE travoprost intracameral implant demonstrated IOP treatment effects of -5.76 mmHg and -7.07 mmHg, respectively. The IOP-lowering treatment effect was significantly greater by 1.31 mmHg for the SE travoprost intracameral implant relative to pre-study PGA monotherapy (95% confidence interval: -2.01, -0.60; P = 0.0003).</p><p><strong>Conclusions: </strong>The SE travoprost intracameral implant demonstrated superior IOP-lowering treatment effect versus pre-study topical PGA monotherapy with a superiority margin that was both statistically significant and clinically meaningful. The greater IOP reduction from baseline while on the SE implant versus pre-study topical PGA monotherapy may be a reflection of the optimized adherence and continuous elution of PGA therapy into the anterior chamber achieved with the SE travoprost intracameral implant.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifiers, NCT03519386 and NCT03868124.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"2357-2367"},"PeriodicalIF":2.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11341799/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141564009","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
Impact of Online Video Game-Based Dichoptic Training on Binocular Vision Rehabilitation in Post-surgical Patients with Intermittent Exotropia. 基于在线视频游戏的二分法训练对间歇性外斜手术后患者双眼视力康复的影响
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-08-01 Epub Date: 2024-06-05 DOI: 10.1007/s40123-024-00978-z
Xuan Qiu, Yusong Zhou, Xinping Yu, Zhonghao Wang, Tao Shen, Daming Deng, Jingchang Chen, Xiaoming Lin, Heping Wu, Ying Kang, Qingqing Ye, Qiwen Chen, Jianhua Yan, Jinrong Li

Introduction: Dichoptic training has emerged as a promising rehabilitation approach for improving binocular visual function in patients with strabismus. A prospective observational study design was employed to assess the effectiveness of online video game-based dichoptic training in rehabilitating binocular visual function in patients who had undergone an operation for intermittent exotropia.

Methods: A total of 64 patients who had undergone an operation for intermittent exotropia were recruited and divided into the training group and the control group based on whether they would receive the dichoptic training. The dichoptic training was conducted for 3 months in the training group and the control group would not accept any form of orthoptic therapy. Assessments of binocular visual functions and deviation were conducted at baseline, 3-month and 6-month follow-up.

Results: Twenty-nine participants in the training group (mean 9.69 ± 2.66 years old) and 26 participants in the control group (mean 8.41 ± 2.64 years old) completed follow-up. At both 3- and 6-month follow-ups, the training group showed superior distance stereopsis compared to the control group, with near stereopsis only showing significant difference at the 6-month follow-up. Additionally, the training group exhibited significantly less distance exo-deviation drift than the control group at these times, and no significant difference was observed in near exo-deviation drift between the groups. The control group had a significantly higher rate of suboptimal surgical outcomes at both the 3- and 6-month follow-up. However, no significant differences were observed in simultaneous perception and fusion functions between the two groups.

Conclusions: Online video game-based dichoptic training has the potential to become a novel postoperative rehabilitation strategy for patients with intermittent exotropia.

简介二向视觉训练已成为改善斜视患者双眼视觉功能的一种很有前景的康复方法。本研究采用前瞻性观察研究设计,评估基于在线视频游戏的二分法训练对间歇性外斜视手术患者双眼视觉功能康复的有效性:方法:共招募了64名接受过间歇性外斜手术的患者,根据他们是否接受二分法训练将其分为训练组和对照组。训练组进行为期3个月的二分法训练,对照组不接受任何形式的矫视治疗。分别在基线、3个月和6个月的随访中对双眼视觉功能和偏差进行评估:完成随访的有训练组 29 名参与者(平均 9.69 ± 2.66 岁)和对照组 26 名参与者(平均 8.41 ± 2.64 岁)。在 3 个月和 6 个月的随访中,与对照组相比,训练组显示出更出色的远视力,只有在 6 个月的随访中,近视力才显示出显著差异。此外,训练组的远视力外差漂移明显少于对照组,两组的近视力外差漂移没有明显差异。在 3 个月和 6 个月的随访中,对照组的手术效果不理想率明显更高。然而,两组在同步感知和融合功能方面没有观察到明显差异:基于在线视频游戏的二分法训练有可能成为间歇性外斜患者的一种新型术后康复策略。
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引用次数: 0
Summary of Research: Cost‑Effectiveness of Faricimab in the Treatment of Diabetic Macular Oedema (DMO): A UK Analysis. 研究摘要:法利单抗治疗糖尿病黄斑水肿 (DMO) 的成本效益:英国分析。
IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2024-08-01 Epub Date: 2024-06-25 DOI: 10.1007/s40123-024-00979-y
Christian Bührer, Thomas Paling, Richard Gale, Tatiana Paulo, Marloes Bagijn

This is a summary of the original article ‟Cost‑Effectiveness of Faricimab in the Treatment of Diabetic Macular Oedema (DMO): A UK Analysis". DMO, a serious eye condition that can lead to vision loss in people with diabetes, is a significant health concern and a lack of knowledge exists about the cost-effectiveness (the balance of a treatment's cost and its effectiveness) of new treatments. This research assessed the cost-effectiveness of a new medication named faricimab, using a mathematical model that simulated the progression of DMO and its treatment over 25 years. The model compared faricimab against relevant therapeutic alternatives for DMO in the UK, including ranibizumab, aflibercept, and bevacizumab. The research discovered that faricimab could offer improved vision results and be cost saving or cost-effective. It also suggested that faricimab could lessen the strain on healthcare services due to its less frequent dosing schedule. Overall, such findings suggest that faricimab is a promising new treatment option for DMO that could benefit patients and the healthcare system. This could have implications for future treatment guidelines and the management of DMO in clinical practice.

本文是原文 "法利西单抗治疗糖尿病黄斑水肿(DMO)的成本效益 "的摘要:英国分析"。糖尿病黄斑水肿是一种严重的眼部疾病,可导致糖尿病患者视力丧失,是一个重大的健康问题,但人们对新疗法的成本效益(治疗成本与治疗效果的平衡)缺乏了解。这项研究利用一个数学模型,模拟了 DMO 25 年的发展过程和治疗方法,评估了一种名为法尼单抗的新药的成本效益。该模型将法尼单抗与英国治疗 DMO 的相关替代疗法(包括雷尼珠单抗、阿弗利百普和贝伐珠单抗)进行了比较。研究发现,法尼单抗可改善视力效果,并能节约成本或提高成本效益。研究还表明,由于法尼单抗的用药频率较低,因此可以减轻医疗服务的压力。总之,这些研究结果表明,法尼单抗是一种很有前景的治疗 DMO 的新疗法,可使患者和医疗系统受益。这可能会对未来的治疗指南和临床实践中的 DMO 管理产生影响。
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引用次数: 0
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Ophthalmology and Therapy
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