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Efficacy and Safety of Efdamrofusp Alfa with Personalized Dosing Intervals in Neovascular Age-Related Macular Degeneration: A Phase II Trial 依替莫福昔治疗新生血管性年龄相关性黄斑变性的有效性和安全性:一项II期试验
IF 4.6 Q1 OPHTHALMOLOGY Pub Date : 2026-01-01 Epub Date: 2025-08-14 DOI: 10.1016/j.xops.2025.100913
Tong Li MD, PhD , Shiqi Yang MD, PhD , Qinghuai Liu MD , Yanping Song MS , Jianping Tong MD , Wenbin Wei MD , Weiqi Chen BS , Hong Dai MD , Wei Wang MS , Miaoqin Wu MD , Guohong Zhou MD , Xuan Xiao MD , Jinglin Zhang MD , Rongrong Zhu MS , Haoyu Li MS , Yafang Wang PhD , Xiaoyu Chen PhD , Shujie Lu MS , Haiwei Du PhD , Han Han-Zhang PhD , Xiaodong Sun MD, PhD

Purpose

This study aims to evaluate the efficacy and safety of high-dose efdamrofusp alfa (IBI302, targeting VEGF and complement C3b/4b) with personalized dosing intervals in patients with neovascular age-related macular degeneration (nAMD).

Design

A multicenter, randomized, double-masked, active-controlled, noninferiority phase II trial.

Participants

A total of 132 anti-VEGF naïve or previously treated participants with nAMD were enrolled.

Methods

Eligible participants were randomized (1:1:1) to receive IBI302 6.4 mg, IBI302 8.0 mg, or aflibercept 2.0 mg. Efdamrofusp alfa groups were dosed every 8 weeks (Q8W) or every 12 weeks (Q12W), based on disease activity assessment at week 20, after 4 monthly injections. The aflibercept 2.0-mg group was dosed Q8W, after 3 monthly injections.

Main Outcome Measures

The primary endpoint was the mean change in best-corrected visual acuity (BCVA) from baseline to week 40. The prespecified noninferiority margin was 4 letters.

Results

The least squares mean (standard error) changes in BCVA from baseline to week 40 were +10.5 (1.5) letters with IBI302 6.4 mg, +9.2 (1.5) letters with IBI302 8.0 mg, and +9.7 (1.5) letters with aflibercept 2.0 mg. The estimated differences were +0.8 (80% confidence interval: –1.9 to 3.6, noninferiority test: P = 0.0115) for IBI302 6.4 mg versus aflibercept 2.0 mg and –0.5 (–3.3 to 2.2, noninferiority test: P = 0.0123) for IBI302 8.0 mg versus aflibercept 2.0 mg. Over 80% of participants in IBI302 groups were dosed Q12W after week 20 and maintained their regimens until the end of study. Treatment-emergent adverse events (TEAEs) in the study eye were reported in 36.4% of participants receiving IBI302 6.4 mg, 37.8% receiving IBI302 8.0 mg, and 23.3% receiving aflibercept 2.0 mg. The most common ocular TEAE was conjunctival hemorrhage (9.1% for 6.4 mg and 11.1% for 8.0 mg) in both IBI302 groups, whereas cataract (7.0%) was the most frequent ocular TEAE in the aflibercept 2.0-mg group.

Conclusions

Efdamrofusp alfa 6.4 and 8.0 mg dosed up to Q12W demonstrated noninferior visual gain to aflibercept 2.0 mg Q8W. Moreover, IBI302 groups were well tolerated. These findings suggested that high-dose IBI302 with extended dosing intervals could provide sustained visual benefits for patients with nAMD.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
目的:本研究旨在评价高剂量efdamrofusp (IBI302,靶向VEGF和补体C3b/4b)个体化给药间隔治疗新生血管性年龄相关性黄斑变性(nAMD)患者的疗效和安全性。设计一项多中心、随机、双盲、主动对照、非劣效性的II期试验。共纳入132名抗vegf naïve或先前接受过nAMD治疗的参与者。方法将符合条件的受试者按1:1:1的比例随机分为IBI302 6.4 mg、IBI302 8.0 mg和afliberept 2.0 mg。注射4个月后,根据第20周的疾病活度评估,每8周(Q8W)或每12周(Q12W)给药一次Efdamrofusp α组。afliberept 2.0 mg组在3个月后给予Q8W注射。主要终点是最佳矫正视力(BCVA)从基线到第40周的平均变化。预定的非劣效距为4个字母。结果从基线到第40周,最小二乘平均值(标准误差)变化为:IBI302 6.4 mg组+10.5(1.5)个字母,IBI302 8.0 mg组+9.2(1.5)个字母,afliberept 2.0 mg组+9.7(1.5)个字母。IBI302 6.4 mg与aflibercept 2.0 mg的估计差异为+0.8(80%置信区间:-1.9至3.6,非劣效性试验:P = 0.0115), IBI302 8.0 mg与aflibercept 2.0 mg的估计差异为-0.5(-3.3至2.2,非劣效性试验:P = 0.0123)。IBI302组中超过80%的参与者在第20周后服用Q12W,并维持他们的方案直到研究结束。在接受IBI302 6.4 mg, 37.8%接受IBI302 8.0 mg, 23.3%接受阿伯西普2.0 mg的受试者中,有36.4%的受试者报告了研究中出现的治疗不良事件(teae)。在IBI302组中,最常见的眼部TEAE是结膜出血(6.4 mg组为9.1%,8.0 mg组为11.1%),而在afliberept 2.0 mg组中,白内障(7.0%)是最常见的眼部TEAE。结论给药至Q12W时,sefdamrofusp 6.4和8.0 mg与afliberept 2.0 mg Q8W相比,视觉增益不差。此外,IBI302组耐受性良好。这些发现表明,延长给药间隔的大剂量IBI302可以为nAMD患者提供持续的视觉益处。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。
{"title":"Efficacy and Safety of Efdamrofusp Alfa with Personalized Dosing Intervals in Neovascular Age-Related Macular Degeneration: A Phase II Trial","authors":"Tong Li MD, PhD ,&nbsp;Shiqi Yang MD, PhD ,&nbsp;Qinghuai Liu MD ,&nbsp;Yanping Song MS ,&nbsp;Jianping Tong MD ,&nbsp;Wenbin Wei MD ,&nbsp;Weiqi Chen BS ,&nbsp;Hong Dai MD ,&nbsp;Wei Wang MS ,&nbsp;Miaoqin Wu MD ,&nbsp;Guohong Zhou MD ,&nbsp;Xuan Xiao MD ,&nbsp;Jinglin Zhang MD ,&nbsp;Rongrong Zhu MS ,&nbsp;Haoyu Li MS ,&nbsp;Yafang Wang PhD ,&nbsp;Xiaoyu Chen PhD ,&nbsp;Shujie Lu MS ,&nbsp;Haiwei Du PhD ,&nbsp;Han Han-Zhang PhD ,&nbsp;Xiaodong Sun MD, PhD","doi":"10.1016/j.xops.2025.100913","DOIUrl":"10.1016/j.xops.2025.100913","url":null,"abstract":"<div><h3>Purpose</h3><div>This study aims to evaluate the efficacy and safety of high-dose efdamrofusp alfa (IBI302, targeting VEGF and complement C3b/4b) with personalized dosing intervals in patients with neovascular age-related macular degeneration (nAMD).</div></div><div><h3>Design</h3><div>A multicenter, randomized, double-masked, active-controlled, noninferiority phase II trial.</div></div><div><h3>Participants</h3><div>A total of 132 anti-VEGF naïve or previously treated participants with nAMD were enrolled.</div></div><div><h3>Methods</h3><div>Eligible participants were randomized (1:1:1) to receive IBI302 6.4 mg, IBI302 8.0 mg, or aflibercept 2.0 mg. Efdamrofusp alfa groups were dosed every 8 weeks (Q8W) or every 12 weeks (Q12W), based on disease activity assessment at week 20, after 4 monthly injections. The aflibercept 2.0-mg group was dosed Q8W, after 3 monthly injections.</div></div><div><h3>Main Outcome Measures</h3><div>The primary endpoint was the mean change in best-corrected visual acuity (BCVA) from baseline to week 40. The prespecified noninferiority margin was 4 letters.</div></div><div><h3>Results</h3><div>The least squares mean (standard error) changes in BCVA from baseline to week 40 were +10.5 (1.5) letters with IBI302 6.4 mg, +9.2 (1.5) letters with IBI302 8.0 mg, and +9.7 (1.5) letters with aflibercept 2.0 mg. The estimated differences were +0.8 (80% confidence interval: –1.9 to 3.6, noninferiority test: P = 0.0115) for IBI302 6.4 mg versus aflibercept 2.0 mg and –0.5 (–3.3 to 2.2, noninferiority test: P = 0.0123) for IBI302 8.0 mg versus aflibercept 2.0 mg. Over 80% of participants in IBI302 groups were dosed Q12W after week 20 and maintained their regimens until the end of study. Treatment-emergent adverse events (TEAEs) in the study eye were reported in 36.4% of participants receiving IBI302 6.4 mg, 37.8% receiving IBI302 8.0 mg, and 23.3% receiving aflibercept 2.0 mg. The most common ocular TEAE was conjunctival hemorrhage (9.1% for 6.4 mg and 11.1% for 8.0 mg) in both IBI302 groups, whereas cataract (7.0%) was the most frequent ocular TEAE in the aflibercept 2.0-mg group.</div></div><div><h3>Conclusions</h3><div>Efdamrofusp alfa 6.4 and 8.0 mg dosed up to Q12W demonstrated noninferior visual gain to aflibercept 2.0 mg Q8W. Moreover, IBI302 groups were well tolerated. These findings suggested that high-dose IBI302 with extended dosing intervals could provide sustained visual benefits for patients with nAMD.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"6 1","pages":"Article 100913"},"PeriodicalIF":4.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145109331","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
Functional Efficacy of Intravitreal Dental Pulp Stem Cells versus Human Umbilical Vein Endothelial Cell–Conditioned Media in Experimental Retinal Ischemia–Reperfusion Injury 玻璃体内牙髓干细胞与人脐静脉内皮细胞条件介质在实验性视网膜缺血再灌注损伤中的功能比较
IF 4.6 Q1 OPHTHALMOLOGY Pub Date : 2026-01-01 Epub Date: 2025-09-18 DOI: 10.1016/j.xops.2025.100941
M. Hossein Nowroozzadeh MD, Mehrnoosh Maalhagh MD, Fatemeh Sanie-Jahromi PhD, Navid Fazlinejad MD, Farid Shahrivar MD, Mohsen Farvardin MD

Objective

To evaluate the efficacy of intravitreal dental pulp stem cell–conditioned medium (DPSC-CM) versus human umbilical vein endothelial cell–CM (HUVEC-CM) in preserving retinal function after ischemia–reperfusion injury (IRI) in rabbits.

Design

Experimental animal study.

Subjects

Eighteen rabbits subjected to retinal IRI and randomized to receive intravitreal injections of DPSC-CM, HUVEC-CM, or balanced salt solution (BSS) (n = 6 per group).

Intervention

After induction of retinal IRI, rabbits received intravitreal injections of DPSC-CM, HUVEC-CM, or BSS. Electroretinography (ERG) was performed 7 days postinjection to assess retinal function, measuring both dark-adapted (DA) and light-adapted (LA) responses.

Main Outcome Measures

Preservation of a-wave and b-wave amplitudes on ERG as indicators of photoreceptor (PR) and bipolar cell function, respectively.

Results

Both DPSC-CM and HUVEC-CM significantly preserved b-wave amplitudes in DA ERG responses compared to BSS (P < 0.05). Dental pulp stem cell–conditioned medium demonstrated superior preservation of a-wave amplitudes, indicating enhanced PR function. Both treatments also maintained LA ERG responses. Transient mucopurulent discharge in 2 DPSC-CM–treated rabbits and a localized posterior subcapsular opacity in one BSS-treated rabbit were observed; all resolved without sequelae.

Conclusions

Intravitreal DPSC-CM and HUVEC-CM are effective in preserving retinal function after IRI, with DPSC-CM showing particular advantage in PR protection. These results support further investigation into DPSC-CM and HUVEC-CM as potential therapies for retinal ischemic conditions, such as retinal artery occlusion and anterior ischemic optic neuropathy.

Financial Disclosure(s)

The authors have no proprietary or commercial interest in any materials discussed in this article.
目的比较玻璃体内牙髓干细胞条件培养基(DPSC-CM)与人脐静脉内皮细胞(HUVEC-CM)对兔缺血再灌注损伤(IRI)后视网膜功能的保护作用。设计实验动物研究。实验对象18只视网膜IRI兔,随机接受玻璃体内注射DPSC-CM、HUVEC-CM或平衡盐溶液(BSS)(每组n = 6)。在诱导视网膜IRI后,兔接受玻璃体内注射DPSC-CM、HUVEC-CM或BSS。注射后7天进行视网膜电图(ERG)评估视网膜功能,测量暗适应(DA)和光适应(LA)反应。ERG上a波和b波振幅的保留分别作为光感受器(PR)和双极细胞功能的指标。结果与BSS相比,DPSC-CM和HUVEC-CM均能显著保留DA ERG反应的b波振幅(P < 0.05)。牙髓干细胞条件培养基显示出优越的a波振幅保存,表明PR功能增强。两种治疗均维持了LA ERG反应。2只dpsc - cm治疗兔出现短暂性粘液脓性排出,1只bss治疗兔出现局部后囊下混浊;全部解决,无后遗症。结论玻璃体内DPSC-CM和HUVEC-CM均能有效保护IRI后的视网膜功能,其中DPSC-CM在PR保护方面表现出特别的优势。这些结果支持进一步研究DPSC-CM和HUVEC-CM作为视网膜缺血性疾病(如视网膜动脉闭塞和前缺血性视神经病变)的潜在治疗方法。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
Lacquer Cracks Detection and Measurement Using Black-on-White Infrared Reflectance and Late-Phase Indocyanine Green Angiography in Pathologic Myopia 病理性近视漆器裂纹的黑白红外反射和后期吲哚菁绿血管造影检测与测量
IF 4.6 Q1 OPHTHALMOLOGY Pub Date : 2026-01-01 Epub Date: 2025-10-30 DOI: 10.1016/j.xops.2025.100987
Matteo Maria Girolamo MD , Emanuele Crincoli MD , Francesca Amoroso MD , Juliana Estrada-Walker MD , Giuseppe Querques MD, PhD , Eric H. Souied MD, PhD , Alexandra Miere MD, PhD

Purpose

The aim of this study is to compare the detection and quantification of lacquer cracks (LCs) using 2 imaging methods: indocyanine green angiography (ICGA) and black-on-white infrared reflectance (bwIR).

Design

Retrospective single-center study.

Subjects

Myopic patients diagnosed with LCs at the Department of Ophthalmology of the University Paris Est Créteil.

Methods

Medical records and multimodal imaging, including bwIR and ICGA, of myopic patients aged >18 years with LCs were reviewed. Two independent graders evaluated the presence of LCs in bwIR images and on late-phase ICGA. Image processing was used to segment and compute the area of LCs on bwIR and ICGA.

Main Outcome Measures

Evaluation and comparison of the rate of detection of LCs on bwIR and late-phase ICGA. Comparison between the extent of LCs detected by bwIR and with late-phase ICGA.

Results

Thirty-two (32) eyes of 22 patients (13 women, 9 men) with a mean age of 54.95 ± 18.7 years were included in this study. Graders detected LCs on bwIR images in 29/32 analyzed cases (90.6% sensitivity, 95% CI: 75%–98%), whereas they detected LCs in 32/32 cases in ICGA images (100% sensitivity). Agreement between graders in detection was very good (Cohen κ = 0.78). The mean area of the LCs detected in bwIR images was 14.58 ± 8.21 mm2, whereas the mean area of the LCs in ICGA was 13.86 ± 8.50 mm2. This difference was not statistically significant in paired analysis (P = 0.73).

Conclusions

In this study, we propose rapid and noninvasive bwIR as a valid and promising noninvasive screening tool for detection of LCs and quantifying their extension.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
目的比较吲哚菁绿血管造影(ICGA)和黑白红外反射(bwIR)两种成像方法对漆裂纹(LCs)的检测和定量。设计回顾性单中心研究。研究对象:巴黎东部大学眼科诊断为LCs的近视患者。方法回顾性分析18岁近视伴LCs患者的病历及bwIR、ICGA等多模态影像资料。两名独立评分者评估了bwIR图像和晚期ICGA中lccs的存在。在bwIR和ICGA上,采用图像处理方法对LCs区域进行分割和计算。主要观察指标bwIR和晚期ICGA中lccs检出率的评价和比较。bwIR和晚期ICGA检测lccs范围的比较。结果纳入22例患者32(32)只眼,其中女13例,男9例,平均年龄54.95±18.7岁。评分者在29/32例分析病例中检测到bwIR图像上的lccs(灵敏度为90.6%,95% CI: 75%-98%),而在32/32例ICGA图像上检测到lccs(灵敏度为100%)。评分者在检测上的一致性非常好(Cohen κ = 0.78)。bwIR图像中lccs的平均面积为14.58±8.21 mm2, ICGA图像中lccs的平均面积为13.86±8.50 mm2。配对分析中差异无统计学意义(P = 0.73)。结论在本研究中,我们提出快速无创bwIR是一种有效且有前景的无创筛查工具,可用于检测lccs并量化其扩展。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 Artifacts in Macular and Peripapillary OCT Angiography in Patients with Different Severities of Glaucoma 不同程度青光眼患者的黄斑和乳头周围OCT血管造影伪影
IF 4.6 Q1 OPHTHALMOLOGY Pub Date : 2026-01-01 Epub Date: 2025-10-10 DOI: 10.1016/j.xops.2025.100964
Yun Hsia MD, MS , Hsiao-Lien Chang MD , Tsing-Hong Wang MD, PhD , Jehn-Yu Huang MD, MPH , Chien-Chia Su MD, PhD

Purpose

To investigate the prevalence and types of artifacts in OCT angiography (OCTA) among patients with different glaucoma severities.

Design

Prospective cross-sectional study.

Subjects

Patients with open-angle glaucoma from a tertiary center were prospectively categorized into mild (mean deviation [MD] of 24-2 visual field ≥ –6 decibels [dB]), moderate (–6 to ≥ –12 dB), advanced (–12 to ≥ –20 dB), and severe glaucoma group (MD < –20 dB).

Methods

AngioVue OCTA was performed three times within a single visit to obtain superficial and deep macular vessel density (VD) with 3 x 3–mm macular scans, and peripapillary VD with 4.5 x 4.5–mm scans centered on the optic disc. The intrasession variability was assessed by the coefficient of variation (CoV). Different types of image artifacts were identified.

Main Outcome Measures

The prevalence of artifacts in patients with varying glaucoma severities, patient-related factors associated with artifact occurrence, and their impact on scan quality index (SQI) and variability of OCTA parameters.

Results

Among the 57 mild, 46 moderate, 46 advanced, and 39 severe glaucoma eyes, half of OCTA images exhibited artifacts. Their prevalence increased from 30% in mild to 67% in severe glaucoma (P < 0.001) for peripapillary scans and from 39% to 62% (P = 0.001) for macular scans. Defocus was the most common artifact (26%) and increased with worsening MD (P = 0.006), contributing to greater CoV of superficial (P = 0.043) and deep (P = 0.024) macular VD and reduced macular SQI (P = 0.018). Peripapillary scans were more affected by artifacts, with defocus (P < 0.001) and eye movement (P = 0.025) increasing as MD worsened, which reduced the peripapillary SQI (P = 0.003 and P < 0.001, respectively). Lower SQI (P < 0.001), eye movement (P = 0.042), and quilt (P = 0.047) were linked to greater CoV of peripapillary VD.

Conclusions

Defocus is the most common OCTA artifact in glaucoma patients, increasing variability in OCTA metrics. Its prevalence rises with glaucoma severity and remains high even in scans with acceptable image quality, emphasizing the need for careful artifact assessment.

Financial Disclosure(s)

The authors have no proprietary or commercial interest in any materials discussed in this article.
目的探讨不同程度青光眼患者OCT血管造影(OCTA)伪影的发生率及类型。前瞻性横断面研究。受试者:三级中心开角型青光眼患者前瞻性分为轻度(24-2视野平均偏差[MD]≥-6分贝[dB])、中度(-6 ~≥-12分贝)、晚期(-12 ~≥-20分贝)和重度青光眼组(MD <; -20分贝)。方法在单次访问中进行三次sangiovue OCTA,以3 x 3 - mm黄斑扫描获得浅部和深层黄斑血管密度(VD),并以视盘为中心进行4.5 x 4.5 mm扫描获得乳头周围VD。用变异系数(CoV)评价种内变异。识别了不同类型的图像伪影。主要观察指标:不同青光眼严重程度患者的伪影发生率、与伪影发生相关的患者相关因素及其对扫描质量指数(SQI)和OCTA参数变异性的影响。结果轻度青光眼57只,中度青光眼46只,晚期青光眼46只,重度青光眼39只,其中一半的OCTA图像出现伪影。在乳头周围扫描中,轻度青光眼的患病率从30%增加到重度青光眼的67% (P < 0.001),黄斑扫描的患病率从39%增加到62% (P = 0.001)。散焦是最常见的伪影(26%),并随着MD的恶化而增加(P = 0.006),导致浅部(P = 0.043)和深层(P = 0.024)黄斑VD的CoV增加,黄斑SQI降低(P = 0.018)。乳头周围扫描受伪影影响更大,随着MD恶化,散焦(P < 0.001)和眼动(P = 0.025)增加,从而降低了乳头周围SQI (P = 0.003和P <; 0.001)。较低的SQI (P < 0.001)、眼球运动(P = 0.042)和被子(P = 0.047)与较大的冠状动脉周围VD相关。结论离焦是青光眼患者最常见的OCTA伪影,增加了OCTA指标的可变性。它的患病率随着青光眼的严重程度而上升,即使在可接受的图像质量扫描中仍然很高,强调需要仔细的伪影评估。作者在本文中讨论的任何材料中没有专有或商业利益。
{"title":"The Artifacts in Macular and Peripapillary OCT Angiography in Patients with Different Severities of Glaucoma","authors":"Yun Hsia MD, MS ,&nbsp;Hsiao-Lien Chang MD ,&nbsp;Tsing-Hong Wang MD, PhD ,&nbsp;Jehn-Yu Huang MD, MPH ,&nbsp;Chien-Chia Su MD, PhD","doi":"10.1016/j.xops.2025.100964","DOIUrl":"10.1016/j.xops.2025.100964","url":null,"abstract":"<div><h3>Purpose</h3><div>To investigate the prevalence and types of artifacts in OCT angiography (OCTA) among patients with different glaucoma severities.</div></div><div><h3>Design</h3><div>Prospective cross-sectional study.</div></div><div><h3>Subjects</h3><div>Patients with open-angle glaucoma from a tertiary center were prospectively categorized into mild (mean deviation [MD] of 24-2 visual field ≥ –6 decibels [dB]), moderate (–6 to ≥ –12 dB), advanced (–12 to ≥ –20 dB), and severe glaucoma group (MD &lt; –20 dB).</div></div><div><h3>Methods</h3><div>AngioVue OCTA was performed three times within a single visit to obtain superficial and deep macular vessel density (VD) with 3 x 3–mm macular scans, and peripapillary VD with 4.5 x 4.5–mm scans centered on the optic disc. The intrasession variability was assessed by the coefficient of variation (CoV). Different types of image artifacts were identified.</div></div><div><h3>Main Outcome Measures</h3><div>The prevalence of artifacts in patients with varying glaucoma severities, patient-related factors associated with artifact occurrence, and their impact on scan quality index (SQI) and variability of OCTA parameters.</div></div><div><h3>Results</h3><div>Among the 57 mild, 46 moderate, 46 advanced, and 39 severe glaucoma eyes, half of OCTA images exhibited artifacts. Their prevalence increased from 30% in mild to 67% in severe glaucoma (<em>P</em> &lt; 0.001) for peripapillary scans and from 39% to 62% (<em>P</em> = 0.001) for macular scans. Defocus was the most common artifact (26%) and increased with worsening MD (<em>P</em> = 0.006), contributing to greater CoV of superficial (<em>P</em> = 0.043) and deep (<em>P</em> = 0.024) macular VD and reduced macular SQI (<em>P</em> = 0.018). Peripapillary scans were more affected by artifacts, with defocus (<em>P</em> &lt; 0.001) and eye movement (<em>P</em> = 0.025) increasing as MD worsened, which reduced the peripapillary SQI (<em>P</em> = 0.003 and <em>P</em> &lt; 0.001, respectively). Lower SQI (<em>P</em> &lt; 0.001), eye movement (<em>P</em> = 0.042), and quilt (<em>P</em> = 0.047) were linked to greater CoV of peripapillary VD.</div></div><div><h3>Conclusions</h3><div>Defocus is the most common OCTA artifact in glaucoma patients, increasing variability in OCTA metrics. Its prevalence rises with glaucoma severity and remains high even in scans with acceptable image quality, emphasizing the need for careful artifact assessment.</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 100964"},"PeriodicalIF":4.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145618260","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
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 Pub Date : 2026-01-01 Epub 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 Pub Date : 2026-01-01 Epub 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。
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引用次数: 0
Baseline Relationships between Visual Function and Inflammatory Markers in the Registry of Moderated-Stage Retinitis Pigmentosa 中度色素性视网膜炎登记中视觉功能和炎症标志物之间的基线关系
IF 4.6 Q1 OPHTHALMOLOGY Pub Date : 2026-01-01 Epub Date: 2025-08-28 DOI: 10.1016/j.xops.2025.100930
Takahiro Hisai MD , Sakurako Shimokawa MD , Masatoshi Fukushima MD, PhD , Kohta Fujiwara MD, PhD , Yoshito Koyanagi MD, PhD , Akie Hirata MD, PhD , Atsushi Takada PharmD , Fuyuka Miyahara , Naoki Nakashima MD, PhD , Yuko Kobayakawa MD, PhD , Go Mawatari CO, PhD , Masataka Ishizu MD, PhD , Naoki Toyama MD , Tomoko Kaida MD, PhD , Kazunori Miyata MD, PhD , Yasuhiro Ikeda MD, PhD , Koh-Hei Sonoda MD, PhD , Yusuke Murakami MD, PhD

Purpose

To analyze the association between visual function and inflammatory markers in the baseline data of a prospective natural history registry of patients with typical retinitis pigmentosa (RP) (Retinitis Pigmentosa Progression and Inflammatory Marker Registry Study [RP-PRIMARY Study]).

Design

A cross-sectional observational study using baseline data from the RP-PRIMARY study.

Participants

A total of 67 patients with moderate-stage typical RP who were treated between October 2021 and October 2022 in 1 of 3 participating hospitals consented to participate and met the inclusion criteria.

Methods

Visual functions were ETDRS best-corrected visual acuity (BCVA), Humphrey Field Analyzer 10-2 program (mean deviation value, and the mean sensitivity within the central 1° area [central 4 points, RS Cent 1’] and the 4° area [central 12 points, RS Cent 4’]), ellipsoid zone (EZ) length, central foveal thickness (CFT), hyper-autofluorescence (AF) ring area, and inflammatory markers were aqueous flare and blood test measurements.

Main Outcome Measures

Association between visual function and inflammatory markers.

Results

The median age of participants was 51 (interquartile range: 43–60) years. Spearman rank correlation coefficient demonstrated that aqueous flare values were negatively correlated with ETDRS BCVA (ρ = –0.35; P = 0.004), RS Cent 1’ (ρ = –0.32; P = 0.008), EZ length (ρ = –0.28; P = 0.023), and hyper-AF ring area (ρ = –0.31; P = 0.016). There was no significant correlation between systemic inflammatory markers and visual function. Eyes with intraocular lens (IOL) had significantly lower values of ETDRS BCVA (P = 0.004), RS Cent 1’ (P = 0.005), RS Cent 4’ (P = 0.010), CFT (P = 0.001), and EZ length (P = 0.011), in addition to higher values of aqueous flare (P < 0.001). Multiple linear regression analysis revealed that eyes with IOL (β = 0.262; P < 0.001) were significantly associated with aqueous flare.

Conclusions

In the baseline data of the RP-PRIMARY study, aqueous flare, an ocular inflammatory marker, was negatively associated with visual function, and IOL implantation was most strongly associated with an increase in aqueous flare in patients with moderate-stage RP. The association between inflammatory markers and disease progression will be evaluated in the ongoing RP-PRIMARY study.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
目的分析典型色素性视网膜炎(RP)患者的前瞻性自然病史登记基线数据中视觉功能与炎症标志物之间的关系(视网膜色素变性进展和炎症标志物登记研究[RP- primary Study])。设计一项横断面观察性研究,使用RP-PRIMARY研究的基线数据。参与者共67名中度典型RP患者,于2021年10月至2022年10月在3家参与医院中的1家接受治疗,同意参与并符合纳入标准。方法视觉功能采用ETDRS最佳矫正视力(BCVA)、Humphrey Field Analyzer 10-2程序(平均偏差值、中心1°区域[中心4点,RS Cent 1′]和4°区域[中心12点,RS Cent 4′]内的平均灵敏度)、椭球区(EZ)长度、中央中央凹厚度(CFT)、超自体荧光(AF)环面积、炎症标志物进行水斑和血液检测。主要观察指标:视觉功能与炎症标志物之间的关系。结果参与者年龄中位数为51岁(四分位数间距为43-60岁)。Spearman秩相关系数表明,水相耀斑值与ETDRS BCVA (ρ = -0.35; P = 0.004)、RS Cent 1′(ρ = -0.32; P = 0.008)、EZ长度(ρ = -0.28; P = 0.023)和超af环面积(ρ = -0.31; P = 0.016)呈负相关。全身炎症标志物与视觉功能无显著相关性。人工晶状体眼的ETDRS BCVA (P = 0.004)、RS Cent 1′(P = 0.005)、RS Cent 4′(P = 0.010)、CFT (P = 0.001)、EZ长度(P = 0.011)值显著低于人工晶状体眼(P < 0.001)。多元线性回归分析显示,人工晶状体眼(β = 0.262; P < 0.001)与水性耀斑显著相关。结论:在RP- primary研究的基线数据中,眼炎症标志物水性耀斑与视功能呈负相关,而在中度RP患者中,人工晶状体植入与水性耀斑的增加密切相关。正在进行的RP-PRIMARY研究将评估炎症标志物与疾病进展之间的关系。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。
{"title":"Baseline Relationships between Visual Function and Inflammatory Markers in the Registry of Moderated-Stage Retinitis Pigmentosa","authors":"Takahiro Hisai MD ,&nbsp;Sakurako Shimokawa MD ,&nbsp;Masatoshi Fukushima MD, PhD ,&nbsp;Kohta Fujiwara MD, PhD ,&nbsp;Yoshito Koyanagi MD, PhD ,&nbsp;Akie Hirata MD, PhD ,&nbsp;Atsushi Takada PharmD ,&nbsp;Fuyuka Miyahara ,&nbsp;Naoki Nakashima MD, PhD ,&nbsp;Yuko Kobayakawa MD, PhD ,&nbsp;Go Mawatari CO, PhD ,&nbsp;Masataka Ishizu MD, PhD ,&nbsp;Naoki Toyama MD ,&nbsp;Tomoko Kaida MD, PhD ,&nbsp;Kazunori Miyata MD, PhD ,&nbsp;Yasuhiro Ikeda MD, PhD ,&nbsp;Koh-Hei Sonoda MD, PhD ,&nbsp;Yusuke Murakami MD, PhD","doi":"10.1016/j.xops.2025.100930","DOIUrl":"10.1016/j.xops.2025.100930","url":null,"abstract":"<div><h3>Purpose</h3><div>To analyze the association between visual function and inflammatory markers in the baseline data of a prospective natural history registry of patients with typical retinitis pigmentosa (RP) (Retinitis Pigmentosa Progression and Inflammatory Marker Registry Study [RP-PRIMARY Study]).</div></div><div><h3>Design</h3><div>A cross-sectional observational study using baseline data from the RP-PRIMARY study.</div></div><div><h3>Participants</h3><div>A total of 67 patients with moderate-stage typical RP who were treated between October 2021 and October 2022 in 1 of 3 participating hospitals consented to participate and met the inclusion criteria.</div></div><div><h3>Methods</h3><div>Visual functions were ETDRS best-corrected visual acuity (BCVA), Humphrey Field Analyzer 10-2 program (mean deviation value, and the mean sensitivity within the central 1° area [central 4 points, RS Cent 1’] and the 4° area [central 12 points, RS Cent 4’]), ellipsoid zone (EZ) length, central foveal thickness (CFT), hyper-autofluorescence (AF) ring area, and inflammatory markers were aqueous flare and blood test measurements.</div></div><div><h3>Main Outcome Measures</h3><div>Association between visual function and inflammatory markers.</div></div><div><h3>Results</h3><div>The median age of participants was 51 (interquartile range: 43–60) years. Spearman rank correlation coefficient demonstrated that aqueous flare values were negatively correlated with ETDRS BCVA (ρ = –0.35; <em>P</em> = 0.004), RS Cent 1’ (ρ = –0.32; <em>P</em> = 0.008), EZ length (ρ = –0.28; <em>P</em> = 0.023), and hyper-AF ring area (ρ = –0.31; <em>P</em> = 0.016). There was no significant correlation between systemic inflammatory markers and visual function. Eyes with intraocular lens (IOL) had significantly lower values of ETDRS BCVA (<em>P</em> = 0.004), RS Cent 1’ (<em>P</em> = 0.005), RS Cent 4’ (<em>P</em> = 0.010), CFT (<em>P</em> = 0.001), and EZ length (<em>P</em> = 0.011), in addition to higher values of aqueous flare (<em>P</em> &lt; 0.001). Multiple linear regression analysis revealed that eyes with IOL (β = 0.262; <em>P</em> &lt; 0.001) were significantly associated with aqueous flare.</div></div><div><h3>Conclusions</h3><div>In the baseline data of the RP-PRIMARY study, aqueous flare, an ocular inflammatory marker, was negatively associated with visual function, and IOL implantation was most strongly associated with an increase in aqueous flare in patients with moderate-stage RP. The association between inflammatory markers and disease progression will be evaluated in the ongoing RP-PRIMARY study.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"6 1","pages":"Article 100930"},"PeriodicalIF":4.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145321056","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
Retinitis Pigmentosa GTPase regulator–Associated Retinal Degeneration: Integrating Patient-Reported Outcomes, Genetic, and Structural Biomarkers 色素性视网膜炎GTPase调节因子相关视网膜变性:整合患者报告的结果、遗传和结构生物标志物
IF 4.6 Q1 OPHTHALMOLOGY Pub Date : 2026-01-01 Epub Date: 2025-08-14 DOI: 10.1016/j.xops.2025.100915
Nuno Gouveia MD, MSc , Jessica Karuntu MD , Hind Almushattat MD , Rufino Silva MD, PhD , Camiel Boon MD, PhD , João Pedro Marques MD, PhD

Purpose

To characterize the genetic, structural, and patient-reported visual function features in a multicenter cohort of patients with retinitis pigmentosa GTPase regulator (RPGR)–associated retinal degeneration.

Design

A cross-sectional, exploratory, international, multicenter study conducted across 3 academic centers.

Subjects

The study included 102 eyes from 51 patients (37.3% female) with genetically confirmed RPGR-associated retinal degeneration. Only male and female patients with a retinitis pigmentosa (RP) phenotype were included, as well as female carriers from RP pedigrees with retinal degeneration.

Methods

Genetic variants were identified and visual acuity (VA) was recorded. Retinal phenotype was classified using fundus autofluorescence. Structural retinal features were assessed using spectral-domain OCT to measure ellipsoid zone (EZ) area and width, central subfield thickness (CST), central point thickness (CPT), subfoveal outer nuclear layer (ONL) thickness, photoreceptor outer segment length (PROS), foveal outer segment pigment epithelial thickness (FOSPET), and FOSPET-PROS ratio. Patient-reported visual function was measured via the Michigan Retinal Degeneration Questionnaire (MRDQ).

Main Outcome Measures

Associations between genetic variant location, retinal structural parameters, and VA, as well as correlations between structural measures and MRDQ domain scores.

Results

Structural endpoints, including EZ area, CPT, PROS, and FOSPET, correlated significantly with all MRDQ domains, and higher disability scores on MRDQ were associated with more advanced retinal degeneration. There were no significant differences in VA or structural features between RPGR variants located in the open reading frame 15 region compared to exons 1 to 13. Eyes from male patients and female patients with an RP phenotype showed significantly decreased VA and structural features compared with eyes of female carriers with focal or radial pattern. A mixed model analysis found that VA was associated with several OCT features including CST, CPT, ONL thickness, EZ area, PROS, and FOSPET.

Conclusions

This study underscores the value of combining genetic, structural, and patient-reported outcome measures in understanding RPGR-associated retinal degeneration. Structural biomarkers provide valuable insights into disease severity and visual impairment, aligning closely with patient-reported visual function. This approach supports further development of patient-centered outcome measures for clinical trials and therapeutic interventions.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
目的:研究色素性视网膜炎GTPase调节剂(RPGR)相关视网膜变性患者的遗传、结构和患者报告的视觉功能特征。设计一项跨3个学术中心进行的横断面、探索性、国际性、多中心研究。该研究包括来自51例遗传确诊的rgr相关视网膜变性患者的102只眼睛(37.3%为女性)。仅包括色素性视网膜炎(RP)表型的男性和女性患者,以及RP谱系中视网膜变性的女性携带者。方法鉴定遗传变异并记录视力(VA)。采用眼底自体荧光法对视网膜表型进行分类。使用光谱域OCT评估视网膜结构特征,测量椭球区(EZ)面积和宽度、中心亚场厚度(CST)、中心点厚度(CPT)、中央凹下外核层(ONL)厚度、光受体外段长度(PROS)、中央凹外段色素上皮厚度(FOSPET)和FOSPET-PROS比值。通过密歇根视网膜变性问卷(MRDQ)测量患者报告的视觉功能。主要结果测量基因变异位置、视网膜结构参数和VA之间的关联,以及结构测量和MRDQ结构域评分之间的相关性。结构终点,包括EZ区、CPT、PROS和FOSPET,与所有MRDQ域显著相关,MRDQ上的残疾评分越高,视网膜变性越严重。与外显子1至13相比,位于开放阅读框15区域的RPGR变体之间的VA或结构特征没有显著差异。男性和女性RP型患者的眼睛与女性病灶型或放射状型携带者的眼睛相比,VA和结构特征明显降低。混合模型分析发现,VA与多个OCT特征相关,包括CST、CPT、ONL厚度、EZ面积、PROS和fopet。结论:本研究强调了结合遗传、结构和患者报告的结果测量在理解rgr相关视网膜变性方面的价值。结构生物标志物为疾病严重程度和视力损害提供了有价值的见解,与患者报告的视觉功能密切相关。这种方法支持进一步发展以患者为中心的临床试验和治疗干预的结果测量。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
Longitudinal Changes in Peripapillary Retinal Nerve Fiber Layer Thickness in Patients with Retinitis Pigmentosa 色素性视网膜炎患者乳头周围视网膜神经纤维层厚度的纵向变化
IF 4.6 Q1 OPHTHALMOLOGY Pub Date : 2026-01-01 Epub Date: 2025-10-10 DOI: 10.1016/j.xops.2025.100966
Jae-Yun Sung MD, PhD , Jung-Tae Kim MD, PhD , Yun-Sang Roh MD , Min-Woo Lee MD, PhD

Purpose

To perform a longitudinal analysis of peripapillary retinal nerve fiber layer (pRNFL) thickness in retinitis pigmentosa (RP) patients.

Design

A retrospective, longitudinal study.

Subjects

We enrolled patients diagnosed with RP and normal controls.

Methods

After the baseline visit, 3 additional measurements of pRNFL thickness at 1-year intervals were analyzed.

Main Outcome Measures

Peripapillary retinal nerve fiber layer thickness.

Results

In total, 142 eyes were included in the study: 72 in the RP group and 70 in the control group. Global pRNFL thicknesses were 89.3 ± 38.9, 86.5 ± 35.2, 84.6 ± 31.8, and 81.6 ± 31.3 μm at baseline, 1 year, 2 years, and 3 years in the RP group (P = 0.022), and 100.9 ± 6.3, 100.8 ± 7.0, 100.0 ± 6.3, and 100.3 ± 6.9 μm in the control group ( = 0.079), respectively. The reduction rate of pRNFL thickness was –2.45 μm/y in the RP group and –0.25 μm/y in the control group. In multivariate analysis, age (estimate = –0.55, P = 0.021) and RP stage (estimate = –15.42, P = 0.005) were significant factors associated with changes in pRNFL thickness in RP patients.

Conclusions

Retinitis pigmentosa patients exhibited a thinner pRNFL and a faster rate of thinning over time compared with healthy controls. In RP patients, pRNFL thinning was significantly associated with age and disease stage, possibly reflecting accelerated damage with disease progression.

Financial Disclosure(s)

The authors have no proprietary or commercial interest in any materials discussed in this article.
目的对色素性视网膜炎(RP)患者乳头周围视网膜神经纤维层(pRNFL)厚度进行纵向分析。设计:回顾性、纵向研究。我们招募了诊断为RP的患者和正常对照。方法基线访视后,每隔1年进行3次额外的pRNFL厚度测量。主要观察指标:视网膜乳头状神经纤维层厚度。结果共纳入142只眼,RP组72只,对照组70只。RP组在基线、1年、2年和3年的pRNFL厚度分别为89.3±38.9、86.5±35.2、84.6±31.8和81.6±31.3 μm (P = 0.022),对照组为100.9±6.3、100.8±7.0、100.0±6.3和100.3±6.9 μm (P = 0.079)。RP组pRNFL厚度减少率为-2.45 μm/y,对照组pRNFL厚度减少率为-0.25 μm/y。在多因素分析中,年龄(估计= -0.55,P = 0.021)和RP分期(估计= -15.42,P = 0.005)是RP患者pRNFL厚度变化的重要影响因素。结论与健康对照相比,色素性视网膜炎患者的pRNFL更薄,随时间的推移变薄的速度更快。在RP患者中,pRNFL变薄与年龄和疾病分期显著相关,可能反映了随着疾病进展而加速的损伤。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
Age-related Eye Disease Studies Supplements and Genetic Risk Score Are Crucial Determinants of Intestinal Microbial Alterations in Advanced Age-Related Macular Degeneration 年龄相关性眼病研究补充剂和遗传风险评分是老年黄斑变性患者肠道微生物改变的关键决定因素
IF 4.6 Q1 OPHTHALMOLOGY Pub Date : 2026-01-01 Epub Date: 2025-08-28 DOI: 10.1016/j.xops.2025.100920
Neda Dadgar PhD , Kevin Fung MD , Scott McClintic MD , Christina Metea , Victor Llorenç MD, PhD , Mohamed Saleh MD, PhD , Yukiko K. Nakamura PhD , Cody Jahrig MD , Lee Kiang MD, PhD , Cathleen Janowitz MS , Sean Davin , Ariel Balter PhD , Kim-Anh Le Cao PhD , Lisa Karstens PhD , Tammy M. Martin PhD , Michael L. Klein MD , Phoebe Lin MD, PhD

Objective

Determine whether an intestinal microbial signature is associated with advanced age-related macular degeneration (AMD); investigate the relationship between the microbiota and AMD genetic risk, intestinal immunoglobulin-A (IgA), and Age-Related Eye Disease Studies (AREDS) supplementation.

Design

Case-control study.

Methods

Fecal 16S rRNA sequencing, DESeq2 differential abundance, and IgA-sequencing.

Subjects

Advanced AMD and age-similar non-AMD control subjects.

Main Outcome Measures

Differential abundance plots using DESeq2, α and β diversity, and impact of AREDS supplementation and genetic risk on AMD microbiota.

Results

In 85 advanced AMD compared with 49 healthy control subjects’ intestinal microbiota, exploratory partial least-squares-discriminant analysis (PLS-DA) showed that gut microbiome composition was able to predict AMD with moderate confidence (cross validation error rates, 0.28–0.36) with the potential for overfitting. A higher AMD genetic risk score was associated with lower gut microbial diversity (P = 0.0086; Spearman r = –0.3), a finding confirmed by multiple linear regression with confounding covariates, whereas AREDS supplementation was associated with increased gut bacterial diversity (coefficient, 2.64; P < 0.05). Differential abundance plots showed increased Proteobacteria and many differentially abundant genera (including Prevotella, Desulfovibrio, Oscillospira, and Ruminococcaceae) in AMD versus controls. Flow cytometry and IgA-sequencing suggested increased IgA-coating of gut bacteria in the age-related maculopathy susceptibility 2 (ARMS2) gene risk genotype, including higher IgA indices for Prevotella. These findings are hypothesis-generating and require functional validation. Predicted metabolic pathways (via piphillin) that differed between AMD and controls included lipid metabolism and xenobiotic processing by cytochrome P450; these findings are inferred and require confirmation by metabolomic studies.

Conclusions

The intestinal microbiome is able to predict advanced AMD via PLS-DA. AREDS supplementation and genetic risk are crucial determinants of the AMD microbiome, which interacts with gut immunity by increasing IgA binding to certain bacteria. Understanding how the gut microbiome and its metabolites interact with gut immunity and host genetics will allow us to further investigate the microbiome to find potentially novel therapeutic targets in AMD.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
目的确定肠道微生物特征是否与高龄黄斑变性(AMD)相关;研究微生物群与AMD遗传风险、肠道免疫球蛋白a (IgA)和年龄相关性眼病研究(AREDS)补充之间的关系。DesignCase-control研究。方法采用粪便16S rRNA测序、DESeq2差异丰度和iga测序。受试者:晚期AMD和年龄相近的非AMD对照受试者。主要结局指标:采用DESeq2、α和β多样性绘制差异丰度图,以及补充AREDS和遗传风险对AMD微生物群的影响。结果85例晚期AMD患者的肠道菌群与49例健康对照者的肠道菌群比较,探索性偏最小二乘判别分析(PLS-DA)显示,肠道菌群组成能够以中等信度预测AMD(交叉验证错误率为0.28-0.36),但存在过拟合的可能性。较高的AMD遗传风险评分与较低的肠道微生物多样性相关(P = 0.0086; Spearman r = -0.3),这一发现经混杂协变量的多元线性回归证实,而补充AREDS与肠道细菌多样性增加相关(系数为2.64;P < 0.05)。差异丰度图显示,与对照组相比,AMD中变形杆菌和许多差异丰度属(包括Prevotella, Desulfovibrio, Oscillospira和Ruminococcaceae)增加。流式细胞术和IgA测序显示,年龄相关性黄斑病变易感性2 (ARMS2)基因风险型肠道细菌IgA包被增加,包括普雷沃氏菌IgA指数升高。这些发现是假设产生的,需要功能验证。预测代谢途径(通过啡肽)在AMD和对照组之间的差异包括脂质代谢和细胞色素P450的异种加工;这些发现是推断出来的,需要代谢组学研究来证实。结论肠道微生物组可通过PLS-DA预测晚期AMD。AREDS补充和遗传风险是AMD微生物组的关键决定因素,AMD微生物组通过增加IgA与某些细菌的结合与肠道免疫相互作用。了解肠道微生物群及其代谢物如何与肠道免疫和宿主遗传学相互作用,将使我们能够进一步研究微生物群,以发现AMD的潜在新治疗靶点。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。
{"title":"Age-related Eye Disease Studies Supplements and Genetic Risk Score Are Crucial Determinants of Intestinal Microbial Alterations in Advanced Age-Related Macular Degeneration","authors":"Neda Dadgar PhD ,&nbsp;Kevin Fung MD ,&nbsp;Scott McClintic MD ,&nbsp;Christina Metea ,&nbsp;Victor Llorenç MD, PhD ,&nbsp;Mohamed Saleh MD, PhD ,&nbsp;Yukiko K. Nakamura PhD ,&nbsp;Cody Jahrig MD ,&nbsp;Lee Kiang MD, PhD ,&nbsp;Cathleen Janowitz MS ,&nbsp;Sean Davin ,&nbsp;Ariel Balter PhD ,&nbsp;Kim-Anh Le Cao PhD ,&nbsp;Lisa Karstens PhD ,&nbsp;Tammy M. Martin PhD ,&nbsp;Michael L. Klein MD ,&nbsp;Phoebe Lin MD, PhD","doi":"10.1016/j.xops.2025.100920","DOIUrl":"10.1016/j.xops.2025.100920","url":null,"abstract":"<div><h3>Objective</h3><div>Determine whether an intestinal microbial signature is associated with advanced age-related macular degeneration (AMD); investigate the relationship between the microbiota and AMD genetic risk, intestinal immunoglobulin-A (IgA), and Age-Related Eye Disease Studies (AREDS) supplementation.</div></div><div><h3>Design</h3><div>Case-control study.</div></div><div><h3>Methods</h3><div>Fecal 16S rRNA sequencing, DESeq2 differential abundance, and IgA-sequencing.</div></div><div><h3>Subjects</h3><div>Advanced AMD and age-similar non-AMD control subjects.</div></div><div><h3>Main Outcome Measures</h3><div>Differential abundance plots using DESeq2, α and β diversity, and impact of AREDS supplementation and genetic risk on AMD microbiota.</div></div><div><h3>Results</h3><div>In 85 advanced AMD compared with 49 healthy control subjects’ intestinal microbiota, exploratory partial least-squares-discriminant analysis (PLS-DA) showed that gut microbiome composition was able to predict AMD with moderate confidence (cross validation error rates, 0.28–0.36) with the potential for overfitting. A higher AMD genetic risk score was associated with lower gut microbial diversity (<em>P</em> = 0.0086; Spearman <em>r</em> = –0.3), a finding confirmed by multiple linear regression with confounding covariates, whereas AREDS supplementation was associated with increased gut bacterial diversity (coefficient, 2.64; <em>P</em> &lt; 0.05). Differential abundance plots showed increased <em>Proteobacteria</em> and many differentially abundant genera (including <em>Prevotella</em>, <em>Desulfovibrio</em>, <em>Oscillospira</em>, and <em>Ruminococcaceae</em>) in AMD versus controls. Flow cytometry and IgA-sequencing suggested increased IgA-coating of gut bacteria in the age-related maculopathy susceptibility 2 (ARMS2) gene risk genotype, including higher IgA indices for <em>Prevotella</em>. These findings are hypothesis-generating and require functional validation. Predicted metabolic pathways (via piphillin) that differed between AMD and controls included lipid metabolism and xenobiotic processing by cytochrome P450; these findings are inferred and require confirmation by metabolomic studies.</div></div><div><h3>Conclusions</h3><div>The intestinal microbiome is able to predict advanced AMD via PLS-DA. AREDS supplementation and genetic risk are crucial determinants of the AMD microbiome, which interacts with gut immunity by increasing IgA binding to certain bacteria. Understanding how the gut microbiome and its metabolites interact with gut immunity and host genetics will allow us to further investigate the microbiome to find potentially novel therapeutic targets in AMD.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":74363,"journal":{"name":"Ophthalmology science","volume":"6 1","pages":"Article 100920"},"PeriodicalIF":4.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145268145","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}
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Ophthalmology science
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