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A Randomized-Controlled Trial of the Efficacy, Safety and Tolerability of Intravitreal Brolucizumab in Patients With Chronic Central Serous Chorioretinopathy With Persistent Fluid in the Absence of Choroidal Neovascular Membrane—BRICS Trial Report II 一项随机对照试验:玻璃体内布卢珠单抗治疗慢性中枢性浆液性脉络膜视网膜病变伴脉络膜新血管膜持续性积液患者的疗效、安全性和耐受性——BRICS试验报告II
IF 4.2 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-12-11 DOI: 10.1016/j.ajo.2025.12.007
Srishti Raksheeth Ramamurthy , Saarang Hansraj , Ragu Kumar , Ritesh Narula , SriniVas R. Sadda , Sobha Sivaprasad , Jay K. Chhablani , Mudit Tyagi , Nikitha Gurram Reddy , Umesh Chandra Behera , Raja Narayanan

Objective

To study the efficacy of brolucizumab in chronic central serous chorioretinopathy (CSCR) with persistent fluid without choroidal neovascular membrane (CNVM).

Design

Prospective randomized-controlled trial with cross-over design.

Subjects

Patients with chronic CSCR (>3 months duration) without CNVM confirmed on optical coherence tomography angiography were enrolled and randomized (1:1) to treatment or control arms.

Methods

Block randomization with stratification for disease duration and central macular thickness (CMT) was done. Patients in the treatment arm received intravitreal brolucizumab at baseline and then PRN. At 3 months follow-up, patients in the control arm with persistent fluid were crossed over to the injection arm.

Main Outcome Measures

The primary outcome was a reduction of CMT on optical coherence tomography >20% compared to baseline. Secondary outcomes included proportion of eyes achieving complete fluid resolution at 1 and 3 months, mean change in CMT, subfoveal choroidal thickness (SFCT), best-corrected visual acuity, and NEI VFQ-25 scores.

Results

Of 42 patients (42 eyes), 3 were lost to follow-up. Final analysis included 22 patients in injection arm and 17 in control arm. Mean age was 52.3 ± 9.3 years; 92.3% were male. Greater than 20% CMT reduction at 1 month was noted in 17/22 (77.27%) in treatment arm and 6/16 eyes (37.5%) in the control arm (p = .01). At 1 month, 13/22 eyes (59%) achieved complete fluid resolution compared to 2/16 (12.5%) eyes in the control arm (p = .003). At 3 months follow-up, 12/20 eyes (60%) in the treatment arm achieved complete fluid resolution compared to 3/16 eyes (18.75%) in the control arm (p = .01). Mean CMT showed reduction in brolucizumab group compared to control at 1 month (158.16 ± 60 vs 318.22 ± 252.64 µm, p = .001) and 3 months (188.11 ± 78.83 vs 340.75.15 ± 264.52 µm, p = .016). Mean SFCT showed reduction in brolucizumab group compared to control at 1 month (419.53 ± 95.51 vs 472.40 ± 77.43 µm, p = .07) and 3 months (403.47 ± 127.36 vs 490.15 ± 105.50 µm, p = .05). 9 of 11 (81.82%) control eyes after crossover showed fluid resolution with brolucizumab. Change in best-corrected visual acuity and NEI VFQ-25 scores was not significant.

Conclusions

Brolucizumab resulted in rapid resolution of fluid in chronic CSCR without CNVM, associated with significant reduction in CMT and SFCT. Long-term studies will help understand recurrence patterns and adverse effect profile.
目的探讨布卢珠单抗治疗慢性中枢性浆液性脉络膜视网膜病变(CSCR)的疗效。前瞻性随机对照试验,交叉设计。受试者纳入经光学相干断层扫描血管造影证实无CNVM的慢性CSCR患者(持续3个月),并随机(1:1)分为治疗组或对照组。方法对病程和中央黄斑厚度(CMT)进行分组随机分层。治疗组患者在基线时接受玻璃体内布卢珠单抗,然后接受PRN。在3个月的随访中,对照组持续积液的患者被转移到注射组。主要结局指标:主要结局是光学相干断层扫描的CMT较基线降低20%。次要结果包括在1个月和3个月时实现完全液体溶解的眼睛比例、CMT的平均变化、中央窝下脉络膜厚度(SFCT)、最佳矫正视力和NEI VFQ-25评分。结果42例(42只眼)中3例失访。注射组22例,对照组17例。平均年龄52.3±9.3岁;92.3%为男性。治疗组17/22只眼(77.27%)和对照组6/16只眼(37.5%)在1个月时CMT下降超过20% (p = 0.01)。1个月时,13/22只眼(59%)获得完全的液体分辨,而对照组为2/16只眼(12.5%)(p = 0.003)。在3个月的随访中,治疗组有12/20只眼(60%)实现了完全的液体溶解,而对照组有3/16只眼(18.75%)实现了完全的液体溶解(p = 0.01)。与对照组相比,brolucizumab组的平均CMT在1个月(158.16±60 vs 318.22±252.64µm, p = 0.001)和3个月(188.11±78.83 vs 340.75.15±264.52µm, p = 0.016)时均有所降低。与对照组相比,brolucizumab组的平均SFCT在1个月(419.53±95.51 vs 472.40±77.43µm, p = 0.07)和3个月(403.47±127.36 vs 490.15±105.50µm, p = 0.05)时均有所下降。交叉治疗后11只对照眼中有9只(81.82%)使用brolucizumab后出现液体溶解。最佳矫正视力和NEI VFQ-25评分变化不显著。结论:在无CNVM的慢性CSCR患者中,brolucizumab可快速解决积液问题,与CMT和SFCT的显著降低相关。长期研究将有助于了解复发模式和不良反应概况。
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引用次数: 0
Comment on: Cellular-Level Assessment of Macular Development in Patients With FEVR Using Multimodal Imaging: A Prospective Cohort Study 评论:使用多模态成像技术评估feevr患者黄斑发展的细胞水平:一项前瞻性队列研究。
IF 4.2 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-12-08 DOI: 10.1016/j.ajo.2025.10.041
Gongpeng Sun , Meixia Zhang
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引用次数: 0
Tirzepatide is Associated With Reduced Risk of Primary Open-Angle Glaucoma and Ocular Hypertension in Patients With Type 2 Diabetes 替西肽与2型糖尿病患者原发性开角型青光眼和高眼压风险降低相关
IF 4.2 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-12-06 DOI: 10.1016/j.ajo.2025.12.003
Alexander T. Hong , Forest Lin , Sally Baxter , Robert N. Weinreb

Purpose

Tirzepatide, a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist (GLP-1 RA), has shown superior efficacy in glycemic control, weight loss, and cardiometabolic outcomes compared to GLP-1 RAs alone. While GLP-1 RAs may offer neuroprotective effects relevant to glaucoma, the impact of dual-incretin therapies like tirzepatide on glaucoma remains unknown. This study investigates the association between tirzepatide initiation and the risk of primary open-angle glaucoma (POAG), ocular hypertension (OHTN), and glaucoma treatment initiation in patients with type 2 diabetes mellitus (T2DM), compared to those initiating selective GLP-1 RAs.

Design

Retrospective clinical cohort study using a nationwide electronic health records network from June 2022 to May 2025.

Subjects

Adults with T2DM who initiated tirzepatide or selective GLP-1 RA therapy. Patients with prior exposure to either drug class, recent addition of second-line antihyperglycemic agents, previous glaucoma diagnosis or surgery, or ocular trauma were excluded.

Methods

Data from 71 U.S. healthcare organizations were analyzed. Propensity score matching (1:1) was conducted to balance cohorts for demographics, comorbidities, medication use, and ophthalmic encounters. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated for each outcome.

Main Outcome Measures

Incidence of POAG, OHTN, and first-line glaucoma treatments (medications or surgery).

Results

We identified 41,850 patients who initiated tirzepatide and 147,828 patients who initiated selective GLP-1 RAs. After matching, 41,849 patients remained in each cohort. Tirzepatide use was associated with a significantly lower risk of POAG (RR 0.50, 95% CI 0.34-0.74), OHTN (RR 0.59, 95% CI 0.40-0.88), and need for glaucoma treatment (RR 0.54, 95% CI 0.45-0.64) compared to selective GLP-1 RAs. Risk reductions persisted in subgroups with concomitant metformin or insulin use. Sensitivity analyses limited to patients aged ≥60 years and comparisons with individual GLP-1 RAs (semaglutide and dulaglutide) yielded consistent trends.

Conclusions

Tirzepatide use was associated with a significantly reduced risk of developing POAG, OHTN, and need for first-line glaucoma treatment compared to selective GLP-1 RAs in patients with T2DM. These findings suggest a potential additional ocular benefit of tirzepatide and support further investigation into its role in glaucoma management.
目的:tirzepatide是一种双重葡萄糖依赖性胰岛素性多肽和胰高血糖素样肽-1受体激动剂(GLP-1 RA),与单独GLP-1 RAs相比,在血糖控制、体重减轻和心脏代谢结果方面显示出更优越的疗效。虽然GLP-1 RAs可能提供与青光眼相关的神经保护作用,但像替西肽这样的双肠促胰岛素治疗对青光眼的影响尚不清楚。本研究探讨了替西肽起始与2型糖尿病(T2DM)患者原发性开角型青光眼(POAG)、高眼压(OHTN)和青光眼起始治疗风险之间的关系,并与那些起始选择性GLP-1 RAs的患者进行了比较。设计:回顾性临床队列研究,使用全国电子健康记录网络,时间为2022年6月至2025年5月。受试者:接受替西肽或选择性GLP-1 RA治疗的成人T2DM患者。既往使用过任何一类药物、近期使用过二线降糖药、既往青光眼诊断或手术或眼部创伤的患者均被排除在外。方法对美国71家医疗机构的数据进行分析。进行倾向评分匹配(1:1),以平衡人口统计学、合并症、药物使用和眼科就诊的队列。计算每个结局的风险比(rr)和95%置信区间(ci)。主要观察指标POAG、OHTN和一线青光眼治疗(药物或手术)的发生率。结果:41,850例患者接受替西帕肽治疗,147,828例患者接受选择性GLP-1 RAs治疗。配对后,每个队列中仍有41849名患者。与选择性GLP-1 RAs相比,使用替西帕肽与POAG (RR 0.50, 95% CI 0.34-0.74)、OHTN (RR 0.59, 95% CI 0.40-0.88)和青光眼治疗需求(RR 0.54, 95% CI 0.45-0.64)的风险显著降低相关。在同时使用二甲双胍或胰岛素的亚组中,风险持续降低。敏感性分析仅限于年龄≥60岁的患者,并与单个GLP-1 RAs (semaglutide和dulaglutide)进行比较,得出了一致的趋势。结论:与选择性GLP-1 RAs相比,在T2DM患者中使用stirzepatide可显著降低发生POAG、OHTN的风险和一线青光眼治疗的需求。这些发现提示替西肽可能有额外的眼部益处,并支持进一步研究其在青光眼治疗中的作用。
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引用次数: 0
Episcleral Osteoma Episcleral骨瘤
IF 4.2 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-12-05 DOI: 10.1016/j.ajo.2025.11.047
Liangyuan Xu , Jing Li , Jianmin Ma
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引用次数: 0
Capsular Tension Ring Use in High Myopic Eyes Undergoing Cataract Surgery: A Systematic Review and Meta-Analysis 白内障手术中高近视眼囊张力环的应用:系统回顾和meta分析
IF 4.2 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-12-05 DOI: 10.1016/j.ajo.2025.12.002
Yu-Min Chang , Ke-Hung Chien , Chi-Jung Wu

Purpose

To evaluate the impact of capsular tension ring (CTR) implantation on refractive outcomes, intraocular lens (IOL) stability, and postoperative complications in high myopic patients undergoing cataract surgery.

Design

Systematic review and meta-analysis.

Methods

A systematic search of PubMed, EMBASE, Cochrane Library, and Google Scholar through March 2025 identified studies comparing cataract surgery with and without CTR implantation in high myopic eyes. The primary outcome was prediction refractive error (PE). Secondary outcomes included absolute refractive error (AE), postoperative corrected distance visual acuity (CDVA), IOL decentration, anterior chamber depth (ACD), posterior capsular opacification (PCO), and Nd:YAG capsulotomy rates. Random-effects meta-analysis, sensitivity analysis, and meta-regression were performed.

Results

Nine studies (4 randomized controlled trials and 5 cohort studies; 846 eyes) were included. CTR implantation did not significantly affect PE (mean difference [MD], 0.00; 95% confidence interval [CI], −0.07 to 0.08; P = .93) or postoperative CDVA (MD, 0.00; 95% CI, −0.06 to 0.06; P = 1.00). However, CTR significantly reduced AE (MD, −0.12; 95% CI, −0.20 to −0.05; P = .001) and IOL decentration (MD, −0.04; 95% CI, −0.07 to −0.01; P = .004).No covariates significantly influenced PE in meta-regression.

Conclusions

CTR implantation appears to modestly improve refractive predictability and IOL stability in high myopic eyes without compromising postoperative visual acuity. However, given the limited evidence base and small effect sizes, these findings should be interpreted with caution. CTR implantation may be considered in selected myopic cases with suspected zonular weakness or large capsular bags where additional capsular stability is desired.
目的探讨人工晶状体张力环(CTR)植入术对高度近视白内障患者屈光效果、人工晶状体稳定性及术后并发症的影响。设计系统回顾和荟萃分析。方法系统检索PubMed、EMBASE、Cochrane Library和谷歌Scholar,检索到2025年3月前对高度近视眼白内障手术植入CTR和不植入CTR进行比较的研究。主要结果为预测屈光不正(PE)。次要结果包括绝对屈光不正(AE)、术后矫正距离视力(CDVA)、人工晶状体脱位、前房深度(ACD)、后囊膜混浊(PCO)和Nd:YAG囊切开率。进行随机效应meta分析、敏感性分析和meta回归分析。结果纳入9项研究(4项随机对照试验和5项队列研究,共846只眼)。CTR植入未显著影响PE(平均差异[MD], 0.00; 95%可信区间[CI], - 0.07 ~ 0.08; P = 0.93)或术后CDVA (MD, 0.00; 95% CI, - 0.06 ~ 0.06; P = 1.00)。然而,CTR显著降低AE (MD, - 0.12; 95% CI, - 0.20至- 0.05;P = .001)和IOL分散(MD, - 0.04; 95% CI, - 0.07至- 0.01;P = .004)。meta回归中没有协变量显著影响PE。结论sctr植入术在不影响术后视力的情况下,可适度改善高度近视患者的屈光可预测性和人工晶状体稳定性。然而,鉴于有限的证据基础和较小的效应量,这些发现应谨慎解释。CTR植入术可以考虑在疑似角膜带无力或大囊袋的近视病例,其中需要额外的囊稳定性。
{"title":"Capsular Tension Ring Use in High Myopic Eyes Undergoing Cataract Surgery: A Systematic Review and Meta-Analysis","authors":"Yu-Min Chang ,&nbsp;Ke-Hung Chien ,&nbsp;Chi-Jung Wu","doi":"10.1016/j.ajo.2025.12.002","DOIUrl":"10.1016/j.ajo.2025.12.002","url":null,"abstract":"<div><h3>Purpose</h3><div>To evaluate the impact of capsular tension ring (CTR) implantation on refractive outcomes, intraocular lens (IOL) stability, and postoperative complications in high myopic patients undergoing cataract surgery.</div></div><div><h3>Design</h3><div>Systematic review and meta-analysis.</div></div><div><h3>Methods</h3><div>A systematic search of PubMed, EMBASE, Cochrane Library, and Google Scholar through March 2025 identified studies comparing cataract surgery with and without CTR implantation in high myopic eyes. The primary outcome was prediction refractive error (PE). Secondary outcomes included absolute refractive error (AE), postoperative corrected distance visual acuity (CDVA), IOL decentration, anterior chamber depth (ACD), posterior capsular opacification (PCO), and Nd:YAG capsulotomy rates. Random-effects meta-analysis, sensitivity analysis, and meta-regression were performed.</div></div><div><h3>Results</h3><div>Nine studies (4 randomized controlled trials and 5 cohort studies; 846 eyes) were included. CTR implantation did not significantly affect PE (mean difference [MD], 0.00; 95% confidence interval [CI], −0.07 to 0.08; <em>P</em> = .93) or postoperative CDVA (MD, 0.00; 95% CI, −0.06 to 0.06; <em>P</em> = 1.00). However, CTR significantly reduced AE (MD, −0.12; 95% CI, −0.20 to −0.05; <em>P</em> = .001) and IOL decentration (MD, −0.04; 95% CI, −0.07 to −0.01; <em>P</em> = .004).No covariates significantly influenced PE in meta-regression.</div></div><div><h3>Conclusions</h3><div>CTR implantation appears to modestly improve refractive predictability and IOL stability in high myopic eyes without compromising postoperative visual acuity. However, given the limited evidence base and small effect sizes, these findings should be interpreted with caution. CTR implantation may be considered in selected myopic cases with suspected zonular weakness or large capsular bags where additional capsular stability is desired.</div></div>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":"283 ","pages":"Pages 109-119"},"PeriodicalIF":4.2,"publicationDate":"2025-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145689324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and Safety of SJP-0132 in Patients With Dry Eye Disease: A Phase 2b Randomized, Double-Masked, Dose-Finding Study SJP-0132治疗干眼病的疗效和安全性:一项2b期随机、双盲、剂量发现研究
IF 4.2 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-12-04 DOI: 10.1016/j.ajo.2025.11.036
Yuichi Hori , Tomoyuki Wada , Kazunori Omatsu

Objective

Evaluate the efficacy, safety, and optimal dose of the TRPV1 antagonist SJP-0132 ophthalmic suspension in patients with dry eye disease.

Design

Randomized, double-masked, multicenter, placebo-controlled, Phase 2b dose-response study in Japan.

Participants

Outpatients aged ≥20 years with dry eye-related subjective symptoms (eye dryness visual analog scale score ≥40; 5-item Dry Eye Questionnaire score ≥6), and objective signs (mean tear-breakup time ≤5 seconds in both eyes; corneal fluorescein staining [CFS] score using Baylor criteria: 2 to 4 for central zone of at least one eye, total score 4 to 20 for all zones, and ≥1 for at least one of the four peripheral corneal regions).

Methods

After a 2-week placebo run-in period, patients were randomized 1:1:1:1 to receive SJP-0132 ophthalmic suspension 0.1%, 0.3%, or 1.0%, or placebo, administered as 1 drop in each eye four times daily for 4 weeks.

Main Outcome Measures

The primary endpoint was the change from baseline to week 4 in CFS score for all zones with SJP-0132 0.3% vs placebo (primary analysis) and SJP-0132 0.1% or 1.0% vs placebo (secondary analysis).

Results

Total 344 patients were randomized and received at least one dose of SJP-0132 0.1% (n = 87), SJP-0132 0.3% (n = 87), SJP-0132 1.0% (n = 85), or placebo (n = 85). For the primary endpoint, there were no statistically significant differences between the SJP-0132 0.3% and placebo groups (between-group difference −0.8; 95% CI −1.7, 0.2; P = .1181), or between the SJP-0132 0.1% (−0.7; 95% CI −1.8, 0.4; P = .1990) or SJP-0132 1.0% (−0.1; 95% CI −1.3, 1.0; P = .8276) and placebo groups. Secondary endpoints showed generally dose-dependent efficacy and safety of SJP-0132. Improvements in subjective symptoms of dry eye, quality of life, and objective signs were observed after 1 week of SJP-0132 administration and maintained through to week 4, with statistically significant differences to placebo observed at some endpoints. Subgroup analyses suggested greater treatment benefits with SJP-0132 0.3% in subgroups based on baseline ocular characteristics. SJP-0132 was generally well tolerated across the dose groups.

Conclusions

SJP-0132 showed generally dose-dependent efficacy and safety. Based on safety and treatment benefits with SJP-0132 0.3% in the overall population and in subgroups, this dose was considered optimal for further development.
目的评价TRPV1拮抗剂SJP-0132眼液在干眼病患者中的疗效、安全性和最佳剂量。日本随机、双盲、多中心、安慰剂对照、2b期剂量反应研究。参与者年龄≥20岁,伴有干眼相关主观症状(眼睛干燥视觉模拟量表评分≥40分;干眼问卷5项评分≥6分)和客观体征(双眼平均泪液破裂时间≤5秒;采用贝勒标准的角膜荧光素染色[CFS]评分:至少一只眼睛中心区评分为2-4分,所有区域评分为4-20分,四个角膜周围区域中至少一个评分≥1分)的门诊患者。方法:在2周安慰剂磨合期后,患者按1:1:1:1:1随机接受SJP-0132眼液0.1%、0.3%或1.0%,或安慰剂,每天4次,每只眼滴1滴,持续4周。主要结局指标主要终点是所有区域从基线到第4周的CFS评分变化,其中SJP-0132与安慰剂相比为0.3%(主要分析),SJP-0132与安慰剂相比为0.1%或1.0%(次要分析)。结果344例患者随机接受至少一剂SJP-0132 0.1% (n=87)、SJP-0132 0.3% (n=87)、SJP-0132 1.0% (n=85)或安慰剂(n=85)治疗。对于主要终点,SJP-0132 0.3%组与安慰剂组之间无统计学差异(组间差异-0.8;95% CI -1.7, 0.2; p=0.1181), SJP-0132 0.1%组(-0.7;95% CI -1.8, 0.4; p=0.1990)或SJP-0132 1.0%组(-0.1;95% CI -1.3, 1.0; p=0.8276)与安慰剂组之间无统计学差异。次要终点显示SJP-0132的有效性和安全性普遍呈剂量依赖性。SJP-0132给药1周后,观察到干眼的主观症状、生活质量和客观体征的改善,并维持到第4周,在某些终点与安慰剂观察到的差异有统计学意义。亚组分析显示,基于基线眼部特征的亚组中,SJP-0132 0.3%的治疗效果更好。SJP-0132在各剂量组均具有良好的耐受性。结论ssjp -0132具有一定的剂量依赖性。基于SJP-0132在总体人群和亚组中的安全性和治疗益处,该剂量被认为是进一步开发的最佳剂量。
{"title":"Efficacy and Safety of SJP-0132 in Patients With Dry Eye Disease: A Phase 2b Randomized, Double-Masked, Dose-Finding Study","authors":"Yuichi Hori ,&nbsp;Tomoyuki Wada ,&nbsp;Kazunori Omatsu","doi":"10.1016/j.ajo.2025.11.036","DOIUrl":"10.1016/j.ajo.2025.11.036","url":null,"abstract":"<div><h3>Objective</h3><div>Evaluate the efficacy, safety, and optimal dose of the TRPV1 antagonist SJP-0132 ophthalmic suspension in patients with dry eye disease.</div></div><div><h3>Design</h3><div>Randomized, double-masked, multicenter, placebo-controlled, Phase 2b dose-response study in Japan.</div></div><div><h3>Participants</h3><div>Outpatients aged ≥20 years with dry eye-related subjective symptoms (eye dryness visual analog scale score ≥40; 5-item Dry Eye Questionnaire score ≥6), and objective signs (mean tear-breakup time ≤5 seconds in both eyes; corneal fluorescein staining [CFS] score using Baylor criteria: 2 to 4 for central zone of at least one eye, total score 4 to 20 for all zones, and ≥1 for at least one of the four peripheral corneal regions).</div></div><div><h3>Methods</h3><div>After a 2-week placebo run-in period, patients were randomized 1:1:1:1 to receive SJP-0132 ophthalmic suspension 0.1%, 0.3%, or 1.0%, or placebo, administered as 1 drop in each eye four times daily for 4 weeks.</div></div><div><h3>Main Outcome Measures</h3><div>The primary endpoint was the change from baseline to week 4 in CFS score for all zones with SJP-0132 0.3% vs placebo (primary analysis) and SJP-0132 0.1% or 1.0% vs placebo (secondary analysis).</div></div><div><h3>Results</h3><div>Total 344 patients were randomized and received at least one dose of SJP-0132 0.1% (<em>n</em> = 87), SJP-0132 0.3% (<em>n</em> = 87), SJP-0132 1.0% (<em>n</em> = 85), or placebo (<em>n</em> = 85). For the primary endpoint, there were no statistically significant differences between the SJP-0132 0.3% and placebo groups (between-group difference −0.8; 95% CI −1.7, 0.2; <em>P</em> = .1181), or between the SJP-0132 0.1% (−0.7; 95% CI −1.8, 0.4; <em>P</em> = .1990) or SJP-0132 1.0% (−0.1; 95% CI −1.3, 1.0; <em>P</em> = .8276) and placebo groups. Secondary endpoints showed generally dose-dependent efficacy and safety of SJP-0132. Improvements in subjective symptoms of dry eye, quality of life, and objective signs were observed after 1 week of SJP-0132 administration and maintained through to week 4, with statistically significant differences to placebo observed at some endpoints. Subgroup analyses suggested greater treatment benefits with SJP-0132 0.3% in subgroups based on baseline ocular characteristics. SJP-0132 was generally well tolerated across the dose groups.</div></div><div><h3>Conclusions</h3><div>SJP-0132 showed generally dose-dependent efficacy and safety. Based on safety and treatment benefits with SJP-0132 0.3% in the overall population and in subgroups, this dose was considered optimal for further development.</div></div>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":"283 ","pages":"Pages 163-175"},"PeriodicalIF":4.2,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145688968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Unilateral Superior Corneal Melts With Iris Prolapse After Retinal Surgery in Rheumatoid Arthritis 类风湿性关节炎视网膜手术后单侧上角膜融化伴虹膜脱垂。
IF 4.2 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-12-04 DOI: 10.1016/j.ajo.2025.11.048
Ritu Arora, Daraius Shroff, Sanat Kumar
{"title":"Unilateral Superior Corneal Melts With Iris Prolapse After Retinal Surgery in Rheumatoid Arthritis","authors":"Ritu Arora,&nbsp;Daraius Shroff,&nbsp;Sanat Kumar","doi":"10.1016/j.ajo.2025.11.048","DOIUrl":"10.1016/j.ajo.2025.11.048","url":null,"abstract":"","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":"282 ","pages":"Pages e10-e11"},"PeriodicalIF":4.2,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145688973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Isolated Haab Striae Point to a Pressured Past 孤立的哈伯条纹指向一个有压力的过去。
IF 4.2 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-12-03 DOI: 10.1016/j.ajo.2025.12.001
Ronak Singh , Wallace L.M. Alward , Erin A. Boese
{"title":"Isolated Haab Striae Point to a Pressured Past","authors":"Ronak Singh ,&nbsp;Wallace L.M. Alward ,&nbsp;Erin A. Boese","doi":"10.1016/j.ajo.2025.12.001","DOIUrl":"10.1016/j.ajo.2025.12.001","url":null,"abstract":"","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":"282 ","pages":"Page e9"},"PeriodicalIF":4.2,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145680586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Retinal Pigment Epithelium Disruption Lesions on Optical Coherence Tomography in Patients With Vitreoretinal Lymphoma 玻璃体视网膜淋巴瘤患者视网膜色素上皮破坏病变的光学相干断层扫描。
IF 4.2 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-12-03 DOI: 10.1016/j.ajo.2025.11.044
Wenwen Chen , Tingting Jiang , Junxiang Gu , Shixue Liu , Xinyi Zhou , Qing Chang

Purpose

To describe the imaging characteristics and clinical relevance of retinal pigment epithelium (RPE) disruption lesions observed on optical coherence tomography (OCT) of patients with biopsy-proven vitreoretinal lymphoma (VRL).

Design

Retrospective interventional case series.

Subjects

Patients diagnosed with VRL at the Eye and ENT Hospital of Fudan University between July 2017 and June 2024.

Methods

The clinical characteristics, outcomes, and multimodal retinal imaging findings of the eligible VRL patients were collected and studied. RPE disruption lesions were defined as full-thickness RPE discontinuities on OCT and were categorized as major (>300 µm) or minor (<300 µm) based on OCT-measured width.

Main Outcome Measures

The associated features of RPE disruption lesions on OCT.

Results

Totally 158 eyes of 81 patients were included in the analysis. RPE disruption lesions were detected in 51 of 65 affected eyes of 36 patients. Most of the lesions (47/51 eyes) were detected at initial presentation or disease onset. On OCT scans, 17 eyes had major RPE disruption lesions, and 34 eyes only had minor disruption lesions. The RPE disruption lesions were colocalized with intraretinal or subretinal infiltration. Among the eyes with full-thickness intraretinal infiltration, 14 eyes (14/24) exhibited perivascular infiltration. Major RPE disruption lesions showed a stronger association with subretinal infiltration (P = .041), while minor disruptions demonstrated preferential correlation with intraretinal infiltration (P = .036). On fundus autofluorescence, the RPE disruption lesions sometimes manifest as characteristic hypo-autofluorescent spots accompanied by hyper-autofluorescent rings. Eyes with minor RPE disruption lesions showed a better visual outcome compared to those with major lesions (P = .013), with statistically significant improvement from baseline after treatment (P = .00017). The median recovery time for the RPE disruption lesions was 2.0 months (IQR 1.5-4.0 months). The accompanied retinal infiltration vanished with the recovery of RPE disruption lesions.

Conclusions

RPE disruption lesions represent frequently occurring yet underrecognized OCT findings in VRL. Notably, the lesions provide diagnostic clues for VRL identification and may reveal a potential migration pathway for lymphocytic infiltrates between sub-RPE and subretinal/intraretinal spaces.
目的探讨经活检证实的玻璃体视网膜淋巴瘤(VRL)患者视网膜色素上皮(RPE)破坏病变的光学相干断层扫描(OCT)的影像学特征及其临床意义。设计回顾性介入病例系列。研究对象2017年7月至2024年6月在复旦大学眼科医院诊断为VRL的患者。方法收集符合条件的VRL患者的临床特点、转归及多模态视网膜影像学表现。RPE断裂病变被定义为OCT上的全层RPE不连续,并根据OCT测量的宽度分为严重(bbb300 μm)和轻微(<300 μm)。主要观察指标:10月RPE破裂病变的相关特征。结果81例患者共158眼纳入分析。36例患者65只眼中有51只发现RPE破坏病变。大多数病变(47/51眼)是在初次出现或发病时发现的。在OCT扫描中,17只眼睛有严重的RPE破坏病变,34只眼睛只有轻微的破坏病变。RPE破坏病变与视网膜内或视网膜下浸润共定位。在全层视网膜浸润的眼中,14眼(14/24)表现为血管周围浸润。严重的RPE破坏病变与视网膜下浸润的相关性更强(P=0.041),而轻微的RPE破坏病变与视网膜内浸润的相关性更强(P=0.036)。在眼底自体荧光中,RPE破坏病变有时表现为特征性的低自体荧光斑点伴超自体荧光环。RPE损伤较小的眼睛的视力结果优于大病变的眼睛(P=0.013),治疗后较基线有统计学意义的改善(P=0.00017)。RPE损伤的中位恢复时间为2.0个月(IQR为1.5-4.0个月)。伴视网膜浸润随RPE损伤恢复而消失。结论srpe断裂病变是VRL中常见但未被充分认识的OCT表现。值得注意的是,这些病变为VRL的识别提供了诊断线索,并可能揭示了rpe下和视网膜下/视网膜内间隙之间淋巴细胞浸润的潜在迁移途径。
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引用次数: 0
ChatGPT-Assisted Glaucoma Diagnosis: A Health-Equitable Multi-Ancestry Analysis Using Visual Field and Optical Coherence Tomography Data chatgpt辅助青光眼诊断:使用视野和光学相干断层扫描数据进行健康公平的多祖先分析。
IF 4.2 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-12-03 DOI: 10.1016/j.ajo.2025.11.046
ANDY S. HUANG , ANTHONY FAM , HETINCE ZHAO , NICOLE PAULESCU , ANNA FABCZAK-KUBICKA , JANEY L. WIGGS , NAZLEE ZEBARDAST , DAVID S. FRIEDMAN , RON DO , KANZA AZIZ , JAE HEE KANG , TOBIAS ELZE , MENGYU WANG , ALON HARRIS , TAK YEE TANIA TAI , JAMES C. TSAI , LOUIS R. PASQUALE

Purpose

Early glaucoma detection is challenging due to variable ocular anatomy, non-glaucomatous optic neuropathy impacting optical coherence tomography (OCT) results, and the subjective nature of visual field (VF) tests. Multimodal large language models may overcome these challenges to provide equitable and accurate screening diagnoses across ancestries and glaucoma genetic predispositions. We evaluated ChatGPT o1 Pro’s accuracy in identifying glaucoma using circumpapillary retinal nerve fiber layer (RNFL) OCT and VF data, and its consistency across ancestries and glaucoma polygenic risk scores (PRS).

Design

Cross-sectional diagnostic accuracy study.

Settings and Participants

We enrolled 204 participants from the Mount Sinai BioMe Biobank for a comprehensive ophthalmic examination from November 2022 to March 2025. This cross-sectional diagnostic accuracy study included 38% European (EUR) and 62% non-European (non-EUR) participants stratified by low/intermediate (n = 107) and high-risk glaucoma PRS (n = 97). Two glaucoma specialists masked to PRS status provided a consensus reference diagnosis. ChatGPT received only de-identified VFs and OCT-RNFL numerical outputs to determine glaucoma status. Performance metrics were compared with the reference diagnosis. Subgroup comparisons by ancestry (EUR versus non-EUR) and PRS (high versus low/intermediate) were conducted. We used logistic regression models to assess the impacts of ancestry, PRS and ocular parameters on classification accuracy.

Main Outcome Measures

ChatGPT o1 Pro’s diagnostic performance in detecting glaucoma compared to consensus specialist diagnoses, stratified by ancestry and genetic risk.

Results

ChatGPT o1 Pro exhibited 96.0% sensitivity (95% confidence interval (CI): 88.3%-100%), 83.7% specificity (95% CI: 78.3%-89.1%), 85.2% accuracy (95% CI: 80.3%-90.1%), an area under the receiver operator curve (AUC) of 0.899, a positive predictive value (PPV) of 45.3% (95% CI: 31.9%-58.7%), and a negative predictive value (NPV) of 99.3% (95% CI: 98.0%-100%); κ for agreement with the consensus reference was 0.538. No significant differences were observed between EUR and non-EUR subgroups (AUC: 0.894 vs 0.906, P = .79; accuracy: 88.3% vs 83.3%, P = .44) or high and low/intermediate-PRS subgroups (AUC: 0.889 vs 0.922, P = .45; accuracy: 85.4% vs 85.0%, P = .50). Global RNFL was the only determinant of reference disease classification (OR = 1.1 per micron, P < .001).

Conclusion

ChatGPT o1 Pro diagnosed glaucoma similarly to specialists using only VF and OCT data. The model performance was similar across ancestral groups and genetic predispositions to glaucoma.
目的青光眼的早期检测具有挑战性,因为不同的眼部解剖结构,非青光眼视神经病变影响光学相干断层扫描(OCT)结果,以及视野(VF)测试的主观性质。多模态大语言模型可以克服这些挑战,提供公平和准确的筛查诊断,跨越祖先和青光眼遗传易感性。我们使用乳头状视网膜神经纤维层(RNFL) OCT和VF数据评估ChatGPT o1 Pro识别青光眼的准确性,以及其在祖先和青光眼多基因风险评分(PRS)中的一致性。设计、环境和参与者我们从西奈山BioMe生物库招募了204名参与者,于2022年11月至2025年3月进行了全面的眼科检查。这项横断面诊断准确性研究包括38%的欧洲(EUR)和62%的非欧洲(non-EUR)参与者,按低/中(n=107)和高风险青光眼PRS (n=97)分层。两位青光眼专家隐瞒了PRS状态,提供了一致的参考诊断。ChatGPT仅接收去识别的VFs和OCT-RNFL数值输出来确定青光眼状态。将性能指标与参考诊断进行比较。按血统(欧元与非欧元)和PRS(高与低/中等)进行亚组比较。我们使用逻辑回归模型来评估祖先、PRS和眼部参数对分类精度的影响。主要结局指标:与公认的专家诊断相比,chatgpt o1pro在青光眼诊断方面的表现,按血统和遗传风险分层。结果schatgpt o1 Pro的敏感性为96.0%(95%置信区间(CI): 88.3 ~ 100%),特异性为83.7% (95% CI: 78.3 ~ 89.1%),准确性为85.2% (95% CI: 80.3 ~ 90.1%),接收者操作符曲线下面积(AUC)为0.899,阳性预测值(PPV)为45.3% (95% CI: 31.9 ~ 58.7%),阴性预测值(NPV)为99.3% (95% CI: 98.0 ~ 100%);与共识参考一致的κ为0.538。在EUR亚组和非EUR亚组(AUC: 0.894 vs 0.906, p=0.79;准确率:88.3% vs 83.3%, p=0.44)或高和低/中- prs亚组(AUC: 0.889 vs 0.922, p=0.45;准确率:85.4% vs 85.0%, p=0.50)之间未观察到显著差异。全局RNFL是参考疾病分类的唯一决定因素(OR=1.1 /微米,p<0.001)。结论chatgpt 01 Pro诊断青光眼与仅使用VF和OCT数据的专家相似。模型的表现在祖先群体和青光眼的遗传易感性之间是相似的。
{"title":"ChatGPT-Assisted Glaucoma Diagnosis: A Health-Equitable Multi-Ancestry Analysis Using Visual Field and Optical Coherence Tomography Data","authors":"ANDY S. HUANG ,&nbsp;ANTHONY FAM ,&nbsp;HETINCE ZHAO ,&nbsp;NICOLE PAULESCU ,&nbsp;ANNA FABCZAK-KUBICKA ,&nbsp;JANEY L. WIGGS ,&nbsp;NAZLEE ZEBARDAST ,&nbsp;DAVID S. FRIEDMAN ,&nbsp;RON DO ,&nbsp;KANZA AZIZ ,&nbsp;JAE HEE KANG ,&nbsp;TOBIAS ELZE ,&nbsp;MENGYU WANG ,&nbsp;ALON HARRIS ,&nbsp;TAK YEE TANIA TAI ,&nbsp;JAMES C. TSAI ,&nbsp;LOUIS R. PASQUALE","doi":"10.1016/j.ajo.2025.11.046","DOIUrl":"10.1016/j.ajo.2025.11.046","url":null,"abstract":"<div><h3>Purpose</h3><div>Early glaucoma detection is challenging due to variable ocular anatomy, non-glaucomatous optic neuropathy impacting optical coherence tomography (OCT) results, and the subjective nature of visual field (VF) tests. Multimodal large language models may overcome these challenges to provide equitable and accurate screening diagnoses across ancestries and glaucoma genetic predispositions. We evaluated ChatGPT o1 Pro’s accuracy in identifying glaucoma using circumpapillary retinal nerve fiber layer (RNFL) OCT and VF data, and its consistency across ancestries and glaucoma polygenic risk scores (PRS).</div></div><div><h3>Design</h3><div>Cross-sectional diagnostic accuracy study.</div></div><div><h3>Settings and Participants</h3><div>We enrolled 204 participants from the Mount Sinai BioMe Biobank for a comprehensive ophthalmic examination from November 2022 to March 2025. This cross-sectional diagnostic accuracy study included 38% European (EUR) and 62% non-European (non-EUR) participants stratified by low/intermediate (<em>n</em> = 107) and high-risk glaucoma PRS (<em>n</em> = 97). Two glaucoma specialists masked to PRS status provided a consensus reference diagnosis. ChatGPT received only de-identified VFs and OCT-RNFL numerical outputs to determine glaucoma status. Performance metrics were compared with the reference diagnosis. Subgroup comparisons by ancestry (EUR versus non-EUR) and PRS (high versus low/intermediate) were conducted. We used logistic regression models to assess the impacts of ancestry, PRS and ocular parameters on classification accuracy.</div></div><div><h3>Main Outcome Measures</h3><div>ChatGPT o1 Pro’s diagnostic performance in detecting glaucoma compared to consensus specialist diagnoses, stratified by ancestry and genetic risk.</div></div><div><h3>Results</h3><div>ChatGPT o1 Pro exhibited 96.0% sensitivity (95% confidence interval (CI): 88.3%-100%), 83.7% specificity (95% CI: 78.3%-89.1%), 85.2% accuracy (95% CI: 80.3%-90.1%), an area under the receiver operator curve (AUC) of 0.899, a positive predictive value (PPV) of 45.3% (95% CI: 31.9%-58.7%), and a negative predictive value (NPV) of 99.3% (95% CI: 98.0%-100%); κ for agreement with the consensus reference was 0.538. No significant differences were observed between EUR and non-EUR subgroups (AUC: 0.894 vs 0.906, <em>P</em> = .79; accuracy: 88.3% vs 83.3%, <em>P</em> = .44) or high and low/intermediate-PRS subgroups (AUC: 0.889 vs 0.922, <em>P</em> = .45; accuracy: 85.4% vs 85.0%, <em>P</em> = .50). Global RNFL was the only determinant of reference disease classification (OR = 1.1 per micron, <em>P</em> &lt; .001).</div></div><div><h3>Conclusion</h3><div>ChatGPT o1 Pro diagnosed glaucoma similarly to specialists using only VF and OCT data. The model performance was similar across ancestral groups and genetic predispositions to glaucoma.</div></div>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":"283 ","pages":"Pages 129-137"},"PeriodicalIF":4.2,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145680599","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
American Journal of Ophthalmology
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