Ophthalmology science最新文献_第6页

Shorter Viewing Distance Reduces Contrast in Man-Made Environments 较短的观看距离降低了人造环境中的对比度

IF 4.6 Q1 OPHTHALMOLOGY

Ophthalmology science

Pub Date : 2025-10-10 DOI: 10.1016/j.xops.2025.100962

William E. Myles PhD , Sally A. McFadden PhD , Quan V. Hoang MD, PhD

Purpose

Myopia is associated with increased near-work, time spent indoors, and urban environments. This may in part stem from the spatial frequency (SF) composition of the visual environment in such scenarios compared to nature. We investigated the SF content of natural and man-made environments and how the relative contrast experienced may be affected by viewing distance.

Design

Experimental study of environmental contrast.

Subjects, Participants, and Controls

Digital images (n = 594) from natural, mixed-urban, urban, and indoor environments across Singapore.

Methods

The fast Fourier transform was computed and radially averaged, and the slope of the amplitude spectra with SF was determined. The total contrast energy within each SF octave (f–2f) was measured to determine exposure deficits between environments and whether environmental contrast was scale invariant (unaffected by changes in viewing distance).

Main Outcome Measures

Environment differences in SF gradient, total contrast, and scale invariance.

Results

As expected, indoor environments displayed the steepest SF gradients at –1.36 ± 0.1, more than urban (–1.22 ± 0.1, P < 0.01), mixed-urban (–1.09 ± 0.1, P < 0.01), and natural (–1.00 ± 0.1, P < 0.01) environments. Specifically, mixed-urban, urban, and indoor environments all lacked contrast at middle and higher SFs compared with natural scenes (P < 0.01 each). Contrast energy/octave was approximately equal for natural environments, signifying the relative SF composition was scale invariant. This was not true for man-made environments. Contrast energy/octave decreased as a function of SF in mixed-urban, urban, and most rapidly in indoor environments (P < 0.001 each), meaning the total contrast experienced in such environments is directly dependent on viewing distance. Consequently, halving viewing distance when indoors would reduce total perceived middle SF contrast by 35%, despite indoor environments already being deficient compared to nature.

Conclusions

The SF content of natural environments is consistent regardless of viewing distance, signifying scale invariance. This does not apply in man-made environments where contrast at all SFs directly depends on viewing distance. This implies that shorter viewing distances in man-made environments further exacerbate inherent deficits in middle and higher SF contrast, and thus these environments may fail to stimulate the eye with sufficient contrast compared to natural environments, possibly explaining why such environments induce myopia.

Financial Disclosure(s)

The authors have no proprietary or commercial interest in any materials discussed in this article.

目的：近视与工作场所附近、室内和城市环境的时间增加有关。这可能部分源于视觉环境在这种情况下与自然相比的空间频率（SF）组成。我们研究了自然环境和人工环境的SF含量，以及观看距离对相对对比度的影响。设计环境对比的实验研究。受试者、参与者和对照组来自新加坡各地自然、混合城市、城市和室内环境的数字图像（n = 594）。方法计算快速傅里叶变换并径向平均，确定振幅谱随SF的斜率。测量每个SF八度内的总对比度能量（f-2f），以确定环境之间的暴露缺陷，以及环境对比度是否具有尺度不变（不受观看距离变化的影响）。主要结果测量：SF梯度、总对比度和尺度不变性的环境差异。结果室内环境SF梯度最大，为-1.36±0.1，高于城市环境（-1.22±0.1,P < 0.01）、混合城市环境（-1.09±0.1,P < 0.01）和自然环境（-1.00±0.1,P < 0.01）。具体而言，与自然场景相比，混合城市、城市和室内环境在中高SFs下都缺乏对比度（P < 0.01）。对比能量/八度程在自然环境下近似相等，表明相对SF组成是尺度不变的。对于人造环境来说，情况并非如此。在混合城市、城市和室内环境中，对比度能量/八度作为SF的函数下降得最快（P < 0.001），这意味着在这些环境中体验到的总对比度直接依赖于观看距离。因此，尽管室内环境与自然环境相比已经不足，但将室内观看距离减半将使总感知的中SF对比度降低35%。结论自然环境中SF含量与观测距离无关，具有尺度不变性。这并不适用于人造环境，因为所有sf的对比度直接取决于观看距离。这意味着在人造环境中较短的观看距离进一步加剧了中高SF对比度的固有缺陷，因此与自然环境相比，这些环境可能无法以足够的对比度刺激眼睛，这可能解释了为什么这样的环境会诱发近视。作者在本文中讨论的任何材料中没有专有或商业利益。

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引用次数: 0

Genetic Background Predicts Uveal Melanoma Patients’ Outcomes 遗传背景预测葡萄膜黑色素瘤患者的预后

IF 4.6 Q1 OPHTHALMOLOGY

Ophthalmology science

Pub Date : 2025-10-10 DOI: 10.1016/j.xops.2025.100972

Thibault Verrier PhD , Anaïs Le Ven , Alexandre Houy , Erwin Brosens PhD , Emine Kilic MD, PhD , Wishal D. Ramdas MD, PhD , Tolga Bicer MD , Agathe Garcia PhD , Anne-Charlotte Lefranc , Sandra Vanhuele , Amanda F. Kahn , Gaelle Pierron PhD , Alexandre Matet MD, PhD , Nathalie Cassoux MD, PhD , Chrystelle Colas MD, PhD , Manuel Rodrigues MD, PhD , Josselin Noirel PhD , Marc-Henri Stern MD PhD

Objective

Single nucleotide polymorphisms (SNPs) in IRF4 and HERC2 are associated with risk for disomy or monosomy of chromosome 3 (D3 or M3) uveal melanoma (UM), respectively. The aim of this study was to assess the association between germline genetics and UM outcome and the potential use of a derived prognostic signature for UM.

Design

Cohort study from Institut Curie, Paris (France) and Erasmus University Medical Center, Rotterdam (The Netherlands).

Participants

Patients diagnosed with UM at Institut Curie (N = 2059) and Erasmus University Medical Center (N =576).

Methods

Impact of IRF4 and HERC2 SNPs on survival was assessed in a cohort of 1339 patients with UM by Kaplan-Meier analysis and Cox proportional hazard regression. Uveal melanoma subtype-specific risk associations with SNPs and iris color were assessed by generalized linear model regression analyses. Classifier of UM subtypes was trained on 560 patients with UM and validated in 2 independent cohorts.

Main Outcome Measures

We analyzed risk SNPs in the series of patients with UM in relation to tumor and patient characteristics, including eye color, tumor subtype and diameter, and patient outcomes.

Results

IRF4 rs12203592-T and HERC2 rs12913832-G SNPs were associated with improved and worsened progression-free-survival and overall survival, respectively, mainly through their association with chromosome 3 status. Associations between IRF4 and HERC2 risk SNPs and D3 or M3 subtypes, respectively, were largely independent of their role in determining iris pigmentation. A genetic classifier showed significant results in predicting chromosome 3 status and survival but did not outperform established clinical prognostic features.

Conclusions

Our study demonstrates that inherited polymorphisms in IRF4 and HERC2 are independently associated with UM subtype and prognosis, although a SNP-based classifier does not yet outperform the established prognostic model.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

目的研究IRF4和HERC2基因单核苷酸多态性（snp）分别与3号染色体（D3或M3）葡萄膜黑色素瘤（UM）二体或单体的发病风险相关。本研究的目的是评估生殖系遗传学与UM预后之间的关系，以及UM衍生预后标志的潜在用途。来自法国巴黎居里研究所和荷兰鹿特丹伊拉斯谟大学医学中心的设计队列研究。研究对象为居里研究所（N = 2059）和伊拉斯谟大学医学中心（N =576）诊断为UM的患者。方法采用Kaplan-Meier分析和Cox比例风险回归，评估IRF4和HERC2 snp对1339例UM患者生存的影响。通过广义线性模型回归分析评估葡萄膜黑色素瘤亚型特异性风险与snp和虹膜颜色的关联。对560名UM患者进行UM亚型分类器训练，并在2个独立队列中进行验证。我们分析了一系列UM患者的风险snp与肿瘤和患者特征（包括眼睛颜色、肿瘤亚型和直径）以及患者结局的关系。结果sirf4 rs12203592-T和HERC2 rs12913832-G snp分别与无进展生存期和总生存期的改善和恶化相关，主要通过与3号染色体状态相关。IRF4和HERC2风险snp与D3或M3亚型之间的关联在很大程度上独立于它们在决定虹膜色素沉着中的作用。遗传分类器在预测3号染色体状态和生存方面显示出显著的结果，但没有优于已建立的临床预后特征。结论我们的研究表明，IRF4和HERC2的遗传多态性与UM亚型和预后独立相关，尽管基于snp的分类器尚未优于已建立的预后模型。财务披露专有或商业披露可在本文末尾的脚注和披露中找到。

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引用次数: 0

Prospective, Randomized Comparison of Axial Elongation Following LASIK versus Soft Contact Lens Wear in the Contralateral Eye 前瞻性、随机比较LASIK术后对侧眼与软性隐形眼镜配戴后的眼轴伸长

IF 4.6 Q1 OPHTHALMOLOGY

Ophthalmology science

Pub Date : 2025-10-09 DOI: 10.1016/j.xops.2025.100956

Osamu Hieda MD, PhD. , Kiyoshi Yamamura MD. , Koichi Wakimasu MD. , Yo Nakamura MD, PhD. , Shiro Tanaka PhD. , Shigeru Kinoshita MD, PhD.

Purpose

To evaluate whether LASIK induces axial elongation comparable to or less than that observed with continued soft contact lens (SCL) wear in myopic eyes.

Design

A prospective, randomized-controlled within-person clinical trial.

Participants

Forty-two eyes from 21 patients (11 males, 10 females; mean age: 26 ± 4 years) with myopia or compound myopic astigmatism.

Methods

In this contralateral-eye, randomized clinical trial, each participant underwent wavefront-guided (WFG) LASIK in 1 randomly assigned eye, while the fellow eye continued SCL wear. Axial length (AL), spherical equivalent (SE), higher-order aberrations (HOAs), visual acuity, and contrast sensitivity were assessed preoperatively and every 6 months for 2.5 years. The primary outcome was axial elongation from 6 months to 2.5 years postoperatively. Data were analyzed using linear mixed-effects models.

Main Outcome Measures

Axial elongation.

Results

The mean preoperative SE in LASIK-treated eyes was –6.23 ± 1.95 diopters. In the early postoperative phase, a significant reduction in AL exceeding corneal thinning was observed, suggesting true axial shortening. From 6 months to 2.5 years, axial elongation did not significantly differ between the LASIK and SCL eyes. Although HOAs at a 6-mm pupil diameter increased more in LASIK-treated eyes, most participants reported subjectively superior visual quality in those eyes.

Conclusions

LASIK was associated with early axial shortening and did not accelerate long-term axial elongation compared with SCL wear. These results suggest a potential modulatory effect of WFG-LASIK on AL progression and support the need for further longitudinal studies.

Financial Disclosure(s)

The authors have no proprietary or commercial interest in any materials discussed in this article.

目的评价LASIK是否会导致近视患者的眼轴伸长与持续配戴软性接触镜（SCL）相当或更小。设计一项前瞻性、随机对照的人体内临床试验。研究对象：近视或复合近视散光患者21例（男11例，女10例，平均年龄26±4岁），42只眼。方法在对侧眼随机临床试验中，每位参与者随机选择1只眼进行波前引导（WFG） LASIK，而另一只眼继续佩戴SCL。术前评估眼轴长（AL）、球等效（SE）、高阶像差（HOAs）、视力和对比敏感度，每6个月评估一次，随访2.5年。术后6个月至2.5年的主要结局是轴向伸长。数据分析采用线性混合效应模型。主要观察指标：轴向伸长。结果lasik术前平均SE为-6.23±1.95屈光度。在术后早期，观察到AL的显著减少超过角膜变薄，表明真正的轴变短。从6个月到2.5年，LASIK和SCL眼的眼轴伸长无显著差异。虽然在lasik治疗的眼睛中，6毫米瞳孔直径的hoa增加更多，但大多数参与者主观地报告说，这些眼睛的视觉质量更好。结论与SCL磨损相比，slasik与早期轴向缩短有关，而不加速长期轴向延长。这些结果表明WFG-LASIK对AL进展有潜在的调节作用，并支持进一步纵向研究的必要性。作者在本文中讨论的任何材料中没有专有或商业利益。

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引用次数: 0

Involving Patients in Developing a Patient-Reported Outcome Measure for Retinal Detachment 让患者参与开发一种患者报告的视网膜脱离结果测量方法

IF 4.6 Q1 OPHTHALMOLOGY

Ophthalmology science

Pub Date : 2025-10-09 DOI: 10.1016/j.xops.2025.100959

Sonia Manning-Charalampidou FRCSI(Ophth) , Jarinne Woudstra-de Jong MSc , Koorosh Faridpooya MD , Michele Manzulli MD , Saskia van Romunde PhD , Pieter Geeraert MD , Roxane Hillier FRCOphth , Jan van Busschbach PhD , Johannes Vingerling PhD , Konrad Pesudovs PhD

Objective

To develop a retinal detachment-specific patient-reported outcome measure (PROM), by involving patients in item (question) development.

Design

Questionnaire development study carried out in 2 single centers.

Participants

Patients were recruited from the Ophthalmic Emergency Department and the Vitreoretinal Outpatient Clinics of the Rotterdam Eye Hospital (Netherlands), using maximum variance sampling. Inclusion criteria were aged ≥18 years and a diagnosis of primary rhegmatogenous retinal detachment. Patients who had undergone retinal detachment repair by pneumatic retinopexy (a procedure not performed in the Rotterdam Eye Hospital) were recruited from the Vitreoretinal Outpatient Clinics of Newcastle Eye Centre (United Kingdom).

Methods

Telephone interviews using an interview topic list, allowing minimum involvement of the interviewer and maximum involvement of the interviewee. Interview transcripts were coded into items (questions); items were grouped into quality-of-life (QoL) domains (themes) using an established ophthalmic QoL framework. Items similar to each other, too specific, or too unclear were removed. The minimal set of representative items was compared with the literature.

Main Outcome Measures

A minimally and fully representative set of unique retinal detachment-specific items.

Results

Seventy-three patients were interviewed, before or after surgery. We identified 1658 unique items, which we classified into 11 QoL domains. After 3 rounds of item refinement and cognitive interviews, the final, minimally representative item set included 355 items classified in 11 QoL domains: health concerns (45 items), emotional well-being including effects of trauma (45), activity limitation (45), coping (39), visual symptoms (33), inconveniences (33), social well-being (28), ocular symptoms (23), general symptoms (23), economic impact (22), and mobility (19). Of note, 288 items (81%) were new. There was 35% overlap with items developed for patients with macular hole, epiretinal membrane, and retinal vascular occlusions.

Conclusions

We have completed the first stage of developing a retinal detachment-specific PROM with patient involvement. Retinal detachment impacts heavily on patients’ QoL. Most of the QoL impact is unique to retinal detachment and described here for the first time.

Financial Disclosure(s)

The authors have no proprietary or commercial interest in any materials discussed in this article.

目的通过让患者参与项目（问题）的开发，建立视网膜脱离特异性的患者报告结果测量（PROM）。设计问卷开发研究在2个单中心进行。采用最大方差抽样方法，从荷兰鹿特丹眼科医院的眼科急诊科和玻璃体视网膜门诊招募患者。纳入标准为年龄≥18岁，诊断为原发性孔源性视网膜脱离。从纽卡斯尔眼科中心（联合王国）玻璃体视网膜门诊诊所招募了通过充气视网膜固定术修复视网膜脱离的患者（该手术未在鹿特丹眼科医院进行）。方法采用访谈主题表进行电话访谈，尽量减少访谈者的参与，尽量减少被访谈者的参与。访谈记录被编码成项目（问题）；使用已建立的眼科生活质量框架将项目分组到生活质量（QoL）领域（主题）。彼此相似，过于具体或过于不明确的项目被删除。将代表性项目的最小集与文献进行比较。主要结果测量：一组具有最低限度和完全代表性的独特视网膜脱离特异性项目。结果手术前后对73例患者进行了随访。我们确定了1658个唯一条目，并将其分类到11个QoL域。经过3轮项目细化和认知访谈，最终的、最低限度代表性的项目集包括355个项目，分为11个生活质量领域：健康问题（45个）、情绪健康(包括创伤的影响（45个）、活动限制（45个）、应对（39个）、视觉症状（33个）、不便（33个）、社会福利（28个）、眼部症状（23个）、一般症状（23个）、经济影响（22个）和流动性（19个）。值得注意的是，288项（81%）是新产品。与黄斑孔、视网膜前膜和视网膜血管闭塞患者的项目有35%的重叠。结论：我们已经完成了患者参与的视网膜脱离特异性早PROM的第一阶段研究。视网膜脱离严重影响患者的生活质量。大多数对生活质量的影响是视网膜脱离所特有的，这里是第一次描述。作者在本文中讨论的任何材料中没有专有或商业利益。

{"title":"Involving Patients in Developing a Patient-Reported Outcome Measure for Retinal Detachment","authors":"Sonia Manning-Charalampidou FRCSI(Ophth) , Jarinne Woudstra-de Jong MSc , Koorosh Faridpooya MD , Michele Manzulli MD , Saskia van Romunde PhD , Pieter Geeraert MD , Roxane Hillier FRCOphth , Jan van Busschbach PhD , Johannes Vingerling PhD , Konrad Pesudovs PhD","doi":"10.1016/j.xops.2025.100959","DOIUrl":"10.1016/j.xops.2025.100959","url":null,"abstract":"<div><h3>Objective</h3><div>To develop a retinal detachment-specific patient-reported outcome measure (PROM), by involving patients in item (question) development.</div></div><div><h3>Design</h3><div>Questionnaire development study carried out in 2 single centers.</div></div><div><h3>Participants</h3><div>Patients were recruited from the Ophthalmic Emergency Department and the Vitreoretinal Outpatient Clinics of the Rotterdam Eye Hospital (Netherlands), using maximum variance sampling. Inclusion criteria were aged ≥18 years and a diagnosis of primary rhegmatogenous retinal detachment. Patients who had undergone retinal detachment repair by pneumatic retinopexy (a procedure not performed in the Rotterdam Eye Hospital) were recruited from the Vitreoretinal Outpatient Clinics of Newcastle Eye Centre (United Kingdom).</div></div><div><h3>Methods</h3><div>Telephone interviews using an interview topic list, allowing minimum involvement of the interviewer and maximum involvement of the interviewee. Interview transcripts were coded into items (questions); items were grouped into quality-of-life (QoL) domains (themes) using an established ophthalmic QoL framework. Items similar to each other, too specific, or too unclear were removed. The minimal set of representative items was compared with the literature.</div></div><div><h3>Main Outcome Measures</h3><div>A minimally and fully representative set of unique retinal detachment-specific items.</div></div><div><h3>Results</h3><div>Seventy-three patients were interviewed, before or after surgery. We identified 1658 unique items, which we classified into 11 QoL domains. After 3 rounds of item refinement and cognitive interviews, the final, minimally representative item set included 355 items classified in 11 QoL domains: health concerns (45 items), emotional well-being including effects of trauma (45), activity limitation (45), coping (39), visual symptoms (33), inconveniences (33), social well-being (28), ocular symptoms (23), general symptoms (23), economic impact (22), and mobility (19). Of note, 288 items (81%) were new. There was 35% overlap with items developed for patients with macular hole, epiretinal membrane, and retinal vascular occlusions.</div></div><div><h3>Conclusions</h3><div>We have completed the first stage of developing a retinal detachment-specific PROM with patient involvement. Retinal detachment impacts heavily on patients’ QoL. Most of the QoL impact is unique to retinal detachment and described here for the first time.</div></div><div><h3>Financial Disclosure(s)</h3><div>The authors have no proprietary or commercial interest in any materials discussed in this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"6 1","pages":"Article 100959"},"PeriodicalIF":4.6,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145519900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Efficacy and Safety of Low-Concentration Atropine in Slowing Myopia Progression in Children in Japan: The Randomized, Double-Blind Phase II/III ORANGE Study 低浓度阿托品延缓日本儿童近视进展的有效性和安全性：随机、双盲II/III期ORANGE研究

IF 4.6 Q1 OPHTHALMOLOGY

Ophthalmology science

Pub Date : 2025-10-09 DOI: 10.1016/j.xops.2025.100960

Kyoko Ohno-Matsui MD, PhD , Tae Igarashi-Yokoi MD, PhD , Yukie Migita , Yutaka Yamakawa MSc , ORANGE study investigators

Purpose

To evaluate the efficacy and safety of low-concentration atropine ophthalmic solution for slowing disease progression in children with myopia and assessing rebound phenomenon after treatment cessation.

Design

A randomized, double-masked, placebo-controlled, phase II/III clinical trial in Japan.

Subjects

Children (n = 299) aged 5–15 years with cycloplegic objective spherical equivalent (SE) –1.0 to –6.0 diopters (D) in both eyes.

Methods

Subjects were randomized to atropine 0.01%, 0.025%, or placebo (1 drop once daily before bedtime in both eyes) for 24 months before receiving atropine 0.01%, 0.025%, or placebo for a further 12 months.

Main Outcome Measures

The primary endpoint was mean SE change from baseline at month 24; axial length (AL) change was a secondary endpoint. Safety evaluations included ocular adverse drug reactions (ADRs).

Results

Mean SE change from baseline at month 24 with atropine 0.01%, 0.025%, and placebo was –1.31 (standard deviation [SD]) 0.71), –1.02 (SD 0.86), and –1.65 (SD 0.90) D, respectively; least squares (LS) mean (standard error) differences versus placebo were 0.34 (0.08) D and 0.65 (0.08) D (both P < 0.0001). Mean (SD) AL change from baseline at month 24 with atropine 0.01%, 0.025%, and placebo was 0.64 (0.31), 0.51 (0.36), and 0.74 (0.36) mm, respectively; corresponding LS mean (standard error) treatment differences versus placebo were –0.11 (0.03) mm (P < 0.05) and –0.23 (0.03) mm (P < 0.0001). After a switch to placebo from atropine 0.01%, 0.025%, or placebo, LS mean (standard error) SE change from month 24 to month 36 was –0.61 (0.07), –0.75 (0.07), and –0.40 (0.07) D, respectively, which suggested a small, concentration-dependent myopia progression “rebound” effect, which was not considered to be clinically meaningful. Least squares mean (standard error) AL change from month 24 to month 36 was 0.30 (0.03), 0.32 (0.03), and 0.21 (0.03) mm, respectively. The most common ocular ADR over 24 months was photophobia, mostly mild, occurring in 1.0%–10.9% of children receiving atropine 0.01%, 0.025%, or placebo.

Conclusions

Atropine 0.01% and 0.025% slowed myopia progression in children. There was a small, not clinically meaningful, rebound in myopia progression after the cessation of atropine treatment. Both concentrations were well tolerated.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

目的评价低浓度阿托品眼液延缓儿童近视病情进展的有效性和安全性，并评价停药后的反弹现象。DesignA在日本进行的随机、双盲、安慰剂对照的II/III期临床试验。研究对象299名年龄在5-15岁的儿童（n = 299），患有双眼眼截瘫物镜球面等效(SE) -1.0至-6.0屈光度(D)。方法将受试者随机分为0.01%、0.025%阿托品组或安慰剂组（每天睡前1滴，双眼1次），持续24个月，然后再接受0.01%、0.025%阿托品组或安慰剂组，持续12个月。主要终点为24个月时平均SE较基线的变化；轴向长度（AL）变化是次要终点。安全性评价包括眼部药物不良反应（adr）。结果与基线相比，阿托品0.01%、0.025%和安慰剂组第24个月的平均SE变化分别为-1.31（标准差[SD]）、-1.02 （SD 0.86）和-1.65 (SD 0.90) D；与安慰剂相比，最小二乘（LS）平均（标准误差）差异为0.34 (0.08)D和0.65 (0.08)D （P < 0.0001）。与基线相比，阿托品0.01%、0.025%和安慰剂组在第24个月的平均（SD） AL变化分别为0.64（0.31）、0.51（0.36）和0.74 (0.36)mm；相应的LS平均（标准误差）治疗与安慰剂的差异为-0.11 (0.03)mm （P < 0.05）和-0.23 (0.03)mm （P < 0.0001）。在从0.01%阿托品、0.025%阿托品或安慰剂切换到安慰剂后，从第24个月到第36个月，LS平均（标准误差）SE变化分别为-0.61（0.07）、-0.75（0.07）和-0.40 (0.07)D，这表明有一个小的、浓度依赖性的近视进展“反弹”效应，这被认为没有临床意义。最小二乘平均（标准误差）AL变化从第24个月到第36个月分别为0.30（0.03）、0.32（0.03）和0.21 (0.03)mm。24个月内最常见的眼部不良反应是畏光，多为轻度，在接受阿托品0.01%、0.025%或安慰剂治疗的儿童中发生率为1.0%-10.9%。结论0.01%和0.025%的托洛品能减缓儿童近视的进展。停止阿托品治疗后，近视的进展有一个小的，没有临床意义的反弹。两种浓度均耐受良好。财务披露专有或商业披露可在本文末尾的脚注和披露中找到。

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引用次数: 0

In Vitro Stability and Preclinical Safety Evaluation of High-Dose Intravitreal Topotecan in Rabbits: Impact of Dose and Concentration 兔玻璃体内高剂量拓扑替康体外稳定性及临床前安全性评价：剂量和浓度的影响

IF 4.6 Q1 OPHTHALMOLOGY

Ophthalmology science

Pub Date : 2025-10-08 DOI: 10.1016/j.xops.2025.100963

María J. Del Sole PhD , Pablo Nejamkin PhD , Javier Opezzo PhD , Debora Chan PhD , Andrés Farall PhD , Gabriela Lamas MD , Fabiana Lubieniecki MD , David H. Abramson MD , Paula Schaiquevich PhD

Purpose

To assess the stability of concentrated solutions of topotecan and the ocular and systemic safety of administering repeated very high doses of intravitreal (IVi) topotecan in rabbits.

Design

Experimental study.

Subjects

Twenty four nontumor-bearing New Zealand White rabbits.

Main Outcome Measures

In vitro stability of topotecan solutions, hematologic parameters, fundoscopic examination, electroretinography (ERG) response, fundoscopic photography, and histologic assessment.

Methods

Three topotecan solutions (1-4 mg/ml) were assessed for stability at 4°C and –20°C for 1 month of drug reconstitution. Five groups of nontumor-bearing rabbits were used to evaluate systemic and ocular toxicity of 3 monthly doses of topotecan (50 μg, 100 μg, and 200 μg), injected in 50 μL or in 100 μL of diluent, or receiving only the vehicle. Ophthalmic, clinical, and electroretinographic evaluations were performed monthly. One month after the last injection, all eyes were enucleated for histological assessment. Electroretinographic parameters were compared among groups using a linear mixed-effects model (P < 0.05).

Results

Topotecan solutions remained stable. During the study period, no hair loss, weight changes, or hematologic abnormalities were observed in any of the animal groups. Eyes treated with vehicle or injected with 3 doses of topotecan up to 100 μg per dose, delivered in either 50 μL or 100 μL diluent, showed no morphological, histological, or functional evidence of damage to the retina. However, eyes injected with 200 μg showed localized retinal alterations near the injection site on fundoscopy and histological analysis, and a significant decrease in the a- and b-wave amplitudes on ERG compared with the other groups (P < 0.05).

Conclusions

Three monthly IVi injections of topotecan 50 or 100 μg (100 μg and 200 μg human equivalent doses) caused no systemic or ocular toxicity in a nontumor-bearing rabbit model. Repeated 200 μg doses (400 μg human-equivalent dose) resulted in localized retinal morphological alterations and small but detectable changes in electrophysiological parameters. The results of this study may have clinical utility in the assessment of very high-dose topotecan as a salvage treatment of highly compromised eyes with recurrent or relapsed subretinal seeds and retinal tumors.

Financial Disclosures

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

目的评价拓扑替康浓缩溶液的稳定性和高剂量反复玻璃体内给药的眼和全身安全性。DesignExperimental研究。实验对象24只无肿瘤的新西兰白兔。主要观察指标：拓扑替康溶液的体外稳定性、血液学参数、眼底检查、视网膜电图（ERG）反应、眼底摄影和组织学评估。方法观察3种拓扑替康溶液（1 ~ 4 mg/ml）在4°C和-20°C条件下重构1个月的稳定性。采用5组非荷瘤家兔，分别以50 μL、100 μL、200 μg、50 μL、100 μL稀释液和单独给药3个月给药剂量，评价拓扑替康的全身和眼部毒性。每月进行眼科、临床和视网膜电图评估。最后一次注射后1个月，所有眼睛去核进行组织学评估。采用线性混合效应模型比较各组视网膜电图参数（P < 0.05）。结果stopotecan溶液保持稳定。在研究期间，任何动物组均未观察到脱发、体重变化或血液学异常。用对照体或以50 μL或100 μL的稀释液给药3次，每次剂量为100 μg的拓扑替康，均未见视网膜损伤的形态学、组织学或功能证据。然而，注射200 μg后，眼底镜和组织学分析显示，注射部位附近的视网膜发生了局部改变，ERG上的a波和b波振幅与其他组相比显著降低（P < 0.05）。结论每月3次静脉注射拓扑替康50或100 μg （100 μg和200 μg人等效剂量）对非肿瘤家兔模型无全身或眼部毒性作用。重复200 μg剂量（400 μg人体等效剂量）导致视网膜局部形态学改变和电生理参数的微小但可检测的变化。这项研究的结果可能在评估高剂量拓扑替康作为复发或复发的视网膜下种子和视网膜肿瘤的高度受损眼睛的补救性治疗方面具有临床效用。财务披露专有或商业披露可在本文末尾的脚注和披露中找到。

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引用次数: 0

Characteristics of Study Design and Statistical Analysis in OCT-Based Studies of Neurodegeneration 基于oct的神经变性研究的研究设计特点及统计分析

IF 4.6 Q1 OPHTHALMOLOGY

Ophthalmology science

Pub Date : 2025-10-08 DOI: 10.1016/j.xops.2025.100961

Sonny Caplash MD , Helen Song , Amy Waldman MD , Gui-Shuang Ying PhD , Benjamin J. Kim MD

Purpose

To evaluate the design and statistical analysis of recently published clinical studies of retina OCT of neurodegenerative diseases.

Design

Review of 134 publications.

Methods

Clinical and translational publications from 2013-2023 involving human OCT studies were reviewed. Publications were restricted to the top 10 journals of either ophthalmology or neurology based on the SCImago Journal Rank. Data were extracted and analyzed regarding study design characteristics, disease studied, imaging characteristics, and statistical analysis method.

Main Outcome Measures

Characteristics of study design and statistical analysis.

Results

Of the 134 studies, the most commonly investigated diseases were multiple sclerosis (47.8%), Alzheimer disease (31.3%), and Parkinson disease (14.2%). One hundred three (76.9%) studies were cross-sectional, and 31 (23.1%) studies were longitudinal. Of the 42 Alzheimer disease studies, 19.0% used cerebrospinal fluid biomarkers, 26.2% used positron emission tomography imaging, and 4.8% used genetic data to confirm the diagnosis. The peripapillary retinal nerve fiber layer thickness (95 studies) and macular retina layer thickness (96 studies) were the most commonly studied OCT measurements; 69 studies looked at both of these measurements. For 25 (18.7%) of the studies, no statement of image quality criteria or exclusion of subjects or eyes because of image quality criteria was identified. One hundred seventeen (87.3%) studies performed bilateral eye imaging, but only 89 (66.4%) studies performed bilateral image analysis. Of the 89 studies with bilateral eye image analysis, 53 (59.6%) performed analysis at the eye level by combining data from the left and right eye, making each eye (rather than each subject) the unit of analysis. Of the 53 studies performing analysis at the eye level for data from both eyes, the intereye correlation was adjusted in 38 (71.7%) studies, while 15 (28.3%) studies did not account for the intereye correlation. Thirty-seven (27.6%) studies corrected for multiple comparisons.

Conclusion

There may be opportunities for improvement in the study design and statistical analysis of OCT studies of neurodegenerative diseases.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

目的评价近期发表的神经退行性疾病视网膜OCT临床研究的设计和统计分析。134篇出版物的DesignReview。方法回顾2013-2023年涉及人体OCT研究的临床和翻译出版物。根据SCImago期刊排名，出版物被限制在眼科或神经病学的前10名期刊中。提取资料并分析研究设计特点、研究疾病、影像学特征和统计分析方法。主要结果测量：研究设计特点及统计分析。结果134项研究中，最常见的疾病是多发性硬化症（47.8%）、阿尔茨海默病（31.3%）和帕金森病（14.2%）。103项（76.9%）研究为横断面研究，31项（23.1%）研究为纵向研究。在42项阿尔茨海默病研究中，19.0%使用脑脊液生物标志物，26.2%使用正电子发射断层扫描成像，4.8%使用遗传数据来确认诊断。乳头周围视网膜神经纤维层厚度（95项研究）和黄斑视网膜层厚度（96项研究）是最常研究的OCT测量；69项研究同时考察了这两项指标。25项（18.7%）的研究没有说明图像质量标准，也没有因为图像质量标准而排除受试者或眼睛。117例（87.3%）研究进行了双侧眼成像，但只有89例（66.4%）研究进行了双侧图像分析。在89项双侧眼图像分析研究中，53项（59.6%）通过结合左右眼数据在眼水平进行分析，使每只眼睛（而不是每个受试者）成为分析单位。在对双眼数据进行眼水平分析的53项研究中，38项（71.7%）研究调整了眼间相关性，而15项（28.3%）研究没有考虑眼间相关性。37项（27.6%）研究对多重比较进行了修正。结论神经退行性疾病OCT研究的研究设计和统计分析仍有改进的空间。财务披露专有或商业披露可在本文末尾的脚注和披露中找到。

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引用次数: 0

Macrophage-Like Cell Density and Distribution in Relation to Vascular Leakage in Diabetes 巨噬细胞样细胞密度和分布与糖尿病血管渗漏的关系

IF 4.6 Q1 OPHTHALMOLOGY

Ophthalmology science

Pub Date : 2025-10-03 DOI: 10.1016/j.xops.2025.100955

Ece Ozdemir Zeydanli MD , Jay B. Bisen BS , Curtis J. Heisel MD , Koray Ertan PhD , Jeremy A. Lavine MD, PhD , Amani A. Fawzi MD

Purpose

To investigate the relationship between macrophage-like cell (MLC) density and vascular leakage in the macula, an indicator of blood–retinal barrier (BRB) breakdown, in diabetic retinopathy (DR), and to understand whether MLCs cluster within areas of vascular leakage.

Design

Cross-sectional imaging analysis.

Subjects

A total of 161 eyes from 152 diabetic participants with various stages of DR.

Methods

Fluorescein angiography (FA) was used to delineate and quantify macular leakage and OCT angiography was used to visualize MLCs using an averaged 3-μm OCT slab above the vitreoretinal interface. In a subgroup of 36 eyes, MLC density maps were overlaid onto FA images to assess the spatial distribution of MLCs relative to leakage zones and their perimeter.

Main Outcome Measures

Correlation between MLC density and macular leakage, and the spatial distribution of MLCs in relation to leakage zones.

Results

A nonlinear relationship was observed between MLC density and macular leakage, captured by a quadratic model (r² = 0.246, P < 0.001). Macrophage-like cell density increased with leakage, peaking between 50% and 60%, but then declined in eyes with more extensive leakage (>60%). Macrophage-like cells were more likely to cluster near leakage boundaries (P < 0.01), without difference in MLC density inside- versus outside-leakage areas (P = 0.08).

Conclusions

The nonlinear relationship between MLC density and macular leakage in DR, along with MLC accumulation around the borders of leakage, suggest a nuanced role for these cells in DR and BRB breakdown. These findings also suggest a complex interplay among different macrophage populations and may reflect changes in MLC function or migration to deeper retinal layers with advancing leakage.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

目的探讨糖尿病视网膜病变（DR）中巨噬细胞样细胞（MLC）密度与黄斑血管渗漏的关系，了解巨噬细胞样细胞是否聚集在血管渗漏区。设计横断面成像分析。方法采用荧光素血管造影（FA）描绘和定量黄斑渗漏；采用OCT血管造影在玻璃体视网膜界面上方平均3 μm OCT板上显示MLCs。在36只眼的亚组中，将MLC密度图叠加到FA图像上，以评估MLC相对于泄漏区及其周长的空间分布。主要观察指标：MLC密度与黄斑渗漏的相关性，MLC的空间分布与渗漏区之间的关系。结果MLC密度与黄斑渗漏呈非线性关系（r2 = 0.246, P < 0.001）。巨噬细胞样细胞密度随渗漏增加而增加，在50% - 60%之间达到峰值，但在渗漏更广泛的眼睛中下降（>60%）。巨噬细胞样细胞更容易聚集在渗漏边界附近（P < 0.01），渗漏区内外MLC密度无差异（P = 0.08）。结论MLC密度与DR中黄斑渗漏之间的非线性关系，以及MLC在渗漏边缘周围的积累，表明这些细胞在DR和BRB分解中起着微妙的作用。这些发现还表明，不同巨噬细胞群体之间存在复杂的相互作用，可能反映了MLC功能的变化或向视网膜更深层的迁移。财务披露专有或商业披露可在本文末尾的脚注和披露中找到。

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引用次数: 0

ONL1204 for the Treatment of Geographic Atrophy: Phase Ib Study Evaluating Safety, Tolerability, and Efficacy ONL1204用于治疗地理萎缩：Ib期研究评估安全性，耐受性和有效性

IF 4.6 Q1 OPHTHALMOLOGY

Ophthalmology science

Pub Date : 2025-10-03 DOI: 10.1016/j.xops.2025.100954

David M. Kleinman MD , Charles C. Wykoff MD, PhD , Durga S. Borkar MD, MMCi , Robyn H. Guymer PhD, FRANZCO , Andrew J. Kocab PhD , Lindsay Puscas MS , Stephanie C. Wietholter MS , Lori L. Kesteloot PharmD , David N. Zacks MD, PhD

Purpose

To evaluate the safety and tolerability of ONL1204, a novel, small peptide inhibitor of the fragment apoptosis stimulator receptor, for the treatment of patients with geographic atrophy (GA).

Design

A phase Ib multicenter study involving a dose-escalation/open-label (DE/OL) component and a randomized, double-masked, sham-controlled natural history/treatment (NHS/T) component.

Participants

Patients aged ≥55 years with GA secondary to age-related macular degeneration.

Methods

Dose-escalation/OL patients received a single intravitreal injection of either 50 μg, 100 μg, or 200 μg of ONL1204 and were followed for 24 weeks. Participants in the NHS/T component were randomized (1:1:1) to either 50 μg or 200 μg of ONL1204 or sham injection, after a 24-week NHS phase. Two injections were administered 12 weeks apart, and patients were observed for an additional 12 weeks.

Main Outcome Measures

The primary endpoint was safety, assessed by monitoring adverse events (AEs), ophthalmic examination, electrophysiology, fundus photography, fundus autofluorescence, and OCT. Additional endpoints included measurement of GA lesion area and best-corrected visual acuity.

Results

Six patients were enrolled in the DE/OL component and 22 patients in the NHS/T component. All patients in the DE/OL component completed the study with no major safety findings or dose-limiting toxicities. Seventeen patients were randomized in the NHS/T component, with 15 patients completing the study. All ophthalmic AEs were mild or moderate in severity. ONL1204 demonstrated a favorable effect on GA lesion growth, with numerically favorable slower lesion growth compared with the fellow eye in the DE/OL component at 6 months and a numerically slower growth rate (mean difference [standard error of the mean] of –0.524 mm² [0.39]; P = 0.202) in the 200 μg ONL1204 group compared with the sham group in the treatment phase of the NHS/T component. There were no changes in the treatment group with respect to visual acuity suggestive of any safety issues.

Conclusions

ONL1204 was safe and well tolerated at all evaluated doses, with the potential to reduce GA lesion growth and improve vision. These results support further evaluation of ONL1204 in patients with GA.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

目的评价ONL1204治疗地域性萎缩（GA）患者的安全性和耐受性。ONL1204是一种新的片段凋亡刺激受体小肽抑制剂。设计一项Ib期多中心研究，包括剂量递增/开放标签（DE/OL）成分和随机、双掩模、假对照的自然史/治疗（NHS/T）成分。受试者年龄≥55岁，GA继发于年龄相关性黄斑变性。方法剂量递增/OL组患者一次性玻璃体内注射ONL1204 50、100或200 μg，随访24周。在24周的NHS阶段后，NHS/T组的参与者被随机（1:1:1）分为50 μg或200 μg的ONL1204或假注射。两次注射间隔12周，并观察患者另外12周。主要终点是安全性，通过监测不良事件（ae）、眼科检查、电生理、眼底摄影、眼底自身荧光和oct进行评估。其他终点包括GA病变面积和最佳矫正视力的测量。结果6例患者入组DE/OL组，22例入组NHS/T组。DE/OL组的所有患者完成了研究，没有重大的安全性发现或剂量限制性毒性。17名患者被随机分为NHS/T组，其中15名患者完成了研究。所有眼部不良事件的严重程度均为轻度或中度。ONL1204对GA病变生长有良好的影响，在6个月时，与DE/OL成分相比，病变生长速度较慢，在NHS/T成分治疗阶段，200 μg ONL1204组的生长速度较假手术组慢（平均差[平均标准误差]为-0.524 mm2 [0.39]; P = 0.202）。治疗组在视力方面没有提示任何安全问题的变化。结论sonl1204在所有评估剂量下都是安全且耐受性良好的，具有减少GA病变生长和改善视力的潜力。这些结果支持进一步评估ONL1204在GA患者中的应用。财务披露专有或商业披露可在本文末尾的脚注和披露中找到。

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引用次数: 0

The Association of Lapses in Diabetic Retinopathy Care with Vision Impairment 糖尿病视网膜病变护理失误与视力损害的关系

IF 4.6 Q1 OPHTHALMOLOGY

Ophthalmology science

Pub Date : 2025-10-02 DOI: 10.1016/j.xops.2025.100958

Gina Zhu BS , Erik Westlund PhD , Diep Tran MS , Cindy X. Cai MD, MS

Objective

To identify the association of lapses in diabetic retinopathy (DR) care with vision impairment among patients with type 2 diabetes (T2D), stratified by DR severity and treatment status.

Design

Retrospective cohort study.

Subjects

Adults with T2D seen at the Wilmer Eye Institute from 2013 to 2023.

Methods

Propensity score modeling was used to estimate the probability that a patient would experience a lapse in care during a 2-year observation window based on sociodemographic (age, sex, self-reported race or ethnicity, insurance), ocular (baseline visual acuity, ophthalmic comorbidities, history of retinal treatments), and medical factors (Diabetes Complication Severity Index, Charlson Comorbidity Index). Doubly robust logistic regression models using inverse probability weighting of the propensity scores were used to estimate the association of care lapses with vision impairment. We also estimated average marginal effects to examine the probability difference in vision impairment associated with care lapses among patients grouped by DR severity (no DR, nonproliferative DR, proliferative DR) and treatment status (no treatment, any treatment, anti-VEGF only, panretinal photocoagulation only).

Main Outcome Measures

Vision impairment (or vision worse than Snellen equivalent 20/40) at the end of the observation period.

Results

A total of 45 764 patients with 90 440 eyes contributed to the study. Most patients were female (52%), and the average age was 61.7 years. A total of 81% had a lapse in care. Patients who had a lapse in care had 50% higher odds of having vision impairment compared with patients who never lapsed (P < 0.001). This association was seen across all subgroups of DR severity and treatment status (all P < 0.001).

Conclusions

For patients with T2D, a lapse in care was associated with higher odds of having vision impairment, regardless of underlying severity of DR or treatment status. These findings highlight the importance of longitudinal DR care and reducing lapses in care to prevent vision loss.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

目的探讨2型糖尿病（T2D）患者糖尿病视网膜病变（DR）护理失误与视力损害的关系，并按DR严重程度和治疗状况进行分层。设计回顾性队列研究。受试者：2013年至2023年在Wilmer眼科研究所就诊的成人T2D患者。方法采用倾向评分模型，根据社会人口统计学（年龄、性别、自我报告的种族或民族、保险）、视力（基线视力、眼科合并症、视网膜治疗史）和医学因素（糖尿病并发症严重程度指数、Charlson合并症指数），估计患者在2年观察窗口内出现护理失误的概率。使用倾向得分的逆概率加权的双稳健逻辑回归模型来估计护理失误与视力损害的关系。我们还估计了平均边际效应，以检查按DR严重程度（无DR、非增殖性DR、增殖性DR）和治疗状态（未治疗、任何治疗、仅抗vegf、仅全视网膜光凝）分组的患者中与护理疏忽相关的视力损害的概率差异。观察结束时视力受损（或视力低于斯奈伦等效20/40）。结果共纳入45 764例患者，90 440只眼。患者以女性居多（52%），平均年龄61.7岁。共有81%的人有过护理失误。有护理失误的患者视力受损的几率比没有护理失误的患者高50% （P < 0.001）。这种关联在DR严重程度和治疗状态的所有亚组中都存在（均P <； 0.001）。结论：对于T2D患者，无论DR的潜在严重程度或治疗状况如何，护理失误与视力受损的几率较高相关。这些发现强调了纵向DR护理和减少护理失误对预防视力丧失的重要性。财务披露专有或商业披露可在本文末尾的脚注和披露中找到。

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