Ophthalmology. Retina最新文献

英文中文

Litigation Involving Intravitreal Injections in Ophthalmology 涉及眼科玻璃体内注射的诉讼：法律索赔和结果的回顾。

IF 5.7 Q1 OPHTHALMOLOGY

Ophthalmology. Retina

Pub Date : 2026-03-01 Epub Date: 2025-10-09 DOI: 10.1016/j.oret.2025.09.014

Maria A. Bantounou MPharm, MBChB , Matthew R. Starr MD

Purpose

Intravitreal (IVT) injections are among the most commonly performed procedures in ophthalmology. Although generally safe, they do carry some risk. This study aimed to characterize lawsuits related to IVT injections and identify trends and actionable insights relevant to clinical practice and patient safety.

Design

Retrospective medicolegal case review.

Subjects

Sixty IVT injection-related lawsuits.

Methods

The Westlaw database was queried for lawsuits involving IVT injections from 2000 to 2025 using key search terms. Trial court documents, trial court orders, cases, verdicts, and settlements were reviewed. Because all data were publicly available, institutional review board review was not required.

Main Outcome Measures

Case characteristics and litigation outcomes cited in lawsuits.

Results

Sixty IVT-related lawsuits were identified. Louisiana (32%) and California (20%) were the most commonly involved states. The most frequently cited agents were triamcinolone (33.3%), brolucizumab (13.3%), and bevacizumab (13.3%). Male patients comprised the most common plaintiff group (43%). Lawsuits against physicians accounted for 13% (n = 8) of cases, often involving male attending physicians (75%), Veterans Affairs settings (63%), and residents (38%). Common allegations included injection-related injuries and delayed treatment. Outcomes were primarily in favor of the defendant (50%), followed by settlements (undisclosed) in 2 cases (25%): 1 in favor of the plaintiff with an award of $1 607 683 (12.5%) and 1 with an unknown outcome (12.5%). Lawsuits (n = 37) against manufacturers commonly cited product liability (97%) and failure to warn (94%) as the legal claims, and often involved contaminated injections (57%). Twenty-nine cases (78.4%) were settled, including 18 patient claims against manufacturers (median settlement: $193 563; interquartile range [IQR]: $109 118–$258 161), 7 cases (18.9%) were decided for the defendant, and 1 (2.7%) for the plaintiff. Fifteen cases involved fraud claims, primarily Medicare fraud (n = 8) and improper billing (n = 4); among these, 4 were settled, 4 decided for the plaintiff, 4 for the defendant, and 3 remain ongoing. Eight fraud cases included financial awards (median: $2 335 919; IQR: $366 169–$34 999 361).

Conclusions

Three key areas of vulnerability emerged: procedural lapses, inadequate informed consent, and regulatory failures. Addressing these issues may reduce litigation risk and enhance patient safety surrounding IVT injections.

Financial Disclosure(s)

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

目的：玻璃体内（IVT）注射是眼科最常用的手术之一。虽然总体上是安全的，但它们也有一定的风险。本研究旨在描述与IVT注射相关的诉讼，并确定与临床实践和患者安全相关的趋势和可操作的见解。设计：回顾性医学-法律案例回顾。对象：60例静脉注射相关诉讼。方法：使用关键词查询WestLaw数据库2000年至2025年涉及IVT注射的诉讼。审查了初审法院文件、初审法院命令、案件、判决和和解。由于所有数据都是公开的，因此不需要机构审查委员会的审查。主要衡量结果：案件特征和诉讼引用的诉讼结果。结果：共发现60起ivt相关诉讼。路易斯安那州（32%）和加利福尼亚州（20%）是最常见的州。最常被引用的药物是曲安奈德（33.3%）、brolucizumab（13.3%）和贝伐单抗（13.3%）。男性患者是最常见的原告组（43%）。针对医生的诉讼占13% (n=8)，通常涉及男性主治医生（75%）、退伍军人医院（63%）和住院医生（38%）。常见的指控包括与注射有关的伤害和延迟治疗。结果主要有利于被告（50%），其次是两起案件的和解（未披露）（25%），一起案件有利于原告，获得1,607,683美元的赔偿（12.5%），另一起案件结果未知（12.5%）。针对制造商的诉讼（n=37）通常以产品责任（97%）和未警告（94%）作为法律索赔，并且经常涉及污染注射剂（57%）。29起案件（78.4%）达成和解，包括18起患者对制造商的索赔（和解中位数：193,563美元；IQR: 109,118美元至258,161美元），7起案件（18.9%）被判被告胜诉，1起案件（2.7%）被判原告胜诉。15起案件涉及欺诈索赔，主要是医疗保险欺诈（n=8）和不当计费（n=4）；其中，4起已达成和解，4起判原告胜诉，4起判被告胜诉，3起仍在审理中。8起欺诈案件包括经济赔偿（中位数：2,335,919美元；平均金额：366,169美元至34,999,361美元）。结论：出现了三个关键的脆弱性领域：程序失误、知情同意不足和监管失灵。解决这些问题可以减少诉讼风险，并提高静脉注射患者的安全性。

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引用次数: 0

Risk Factors for 15-Letter Visual Acuity Loss from Geographic Atrophy Progression over 1 Year in the Age-Related Eye Disease Study 2 年龄相关性眼病研究中，一年内地理萎缩进展导致15个字母视力丧失的危险因素

IF 5.7 Q1 OPHTHALMOLOGY

Ophthalmology. Retina

Pub Date : 2026-03-01 Epub Date: 2025-09-10 DOI: 10.1016/j.oret.2025.09.003

Emily Vance MPH , Leon von der Emde MD , Souvick Mukherjee PhD , Jintong Hou PhD , Amitha Domalpally MD, PhD , Emily Y. Chew MD , Usha Chakravarthy MD, PhD , Tiarnán D.L. Keenan BM BCh, PhD , AREDS2 Research Group

Purpose

A change of ≥15 letters in best-corrected visual acuity (BCVA) is typically defined as clinically significant by regulatory agencies, but risk factors for rapid 15-letter loss in geographic atrophy (GA) are poorly understood. The purpose was to identify independent risk factors for 15-letter loss within 1 year in eyes with GA.

Design

Post hoc analysis of the Age-Related Eye Disease Study 2.

Participants

Nine hundred sixty-one eyes (743 participants).

Methods

Annual fundus photographs were graded for GA presence/morphology. Best-corrected visual acuity was measured using the ETDRS chart. Multivariable analyses comprised logistic regression for 15-letter loss within 1 year, based on (1) baseline variables (demographic, BCVA, and GA morphology variables, defined at first time point with GA), (2) genetic variables (CFH Y402H and ARMS2), and (3) GA enlargement rate (from first time point with GA).

Main Outcome Measures

Fifteen-letter loss in BCVA within 1 year.

Results

During 1-year follow-up, BCVA declined by ≥15 letters in 53 eyes (5.5%). In a model with baseline variables, the risk factors were as follows: age (adjusted odds ratio [aOR], 1.08; 95% confidence interval [CI], 1.04–1.14; P = 0.0005), closer GA proximity to fovea (aOR, 0.90 per 0.1 mm increase; 95% CI, 0.84–0.97; P = 0.005), current smoking (aOR, 3.85; 95% CI, 1.49–9.97; P = 0.005), and BCVA <20/40 (aOR, 2.09; 95% CI, 1.17–3.74; P = 0.013). In a model with baseline variables and genotype, CFH was a risk factor (aOR, 4.63; 95% CI, 1.27–16.9; P = 0.020; 2 vs. 0 risk alleles), whereas ARMS2 was not. In a model with baseline variables and GA enlargement rate, faster enlargement was a risk factor (aOR, 1.12 per 0.1 mm/year increase; 95% CI, 1.07–1.18; P < 0.0001).

Conclusions

We identified multiple independent risk factors for rapid, clinically significant BCVA loss in GA. We also developed clinically relevant models for different scenarios. These can guide the design and interpretation of interventional trials aimed at decreasing vision loss in GA and provide prognostic information in clinical practice. The risk factors for BCVA loss and faster GA enlargement overlap only partially, so that trial inclusion criteria, power calculations, and covariate adjustment should differ according to the choice of a functional versus structural measure as the primary end point.

Financial Disclosure(s)

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

目的：监管机构通常将最佳矫正视力（BCVA）变化≥15个字母定义为具有临床意义，但对地理萎缩（GA）快速15个字母丧失的危险因素知之甚少。目的是确定GA眼一年内15字母丢失的独立危险因素。设计：年龄相关性眼病研究2的事后分析。参与者：961只眼睛（743名参与者）。方法：对年度眼底照片进行GA存在/形态分级。BCVA采用糖尿病视网膜病变早期治疗研究图表进行测量。多变量分析包括一年内15个字母丢失的逻辑回归，基于(i)基线变量（人口统计学，BCVA和GA形态学变量，在GA的第一个时间点定义），（ii）遗传变量（CFH Y402H和ARMS2），以及（iii） GA扩大率（从GA的第一个时间点开始）。主要观察指标：一年内BCVA患者损失15个字母。结果：1年随访期间，53眼（5.5%）BCVA下降≥15个字母。在具有基线变量的模型中，危险因素为：年龄（校正优势比[aOR] 1.08, 95%置信区间[CI] 1.04-1.14, p=0.0005）、GA靠近中央凹（每增加0.1 mm aOR为0.90,95% CI为0.84-0.97,p=0.005）、当前吸烟（aOR为3.85,1.49-9.97,p=0.005）和BCVA。结论：我们确定了GA患者BCVA快速、临床显著丧失的多个独立危险因素。我们还针对不同的情况开发了临床相关的模型。这些可以指导旨在减少GA患者视力丧失的介入性试验的设计和解释，并为临床实践提供预后信息。BCVA丧失和GA快速扩大的危险因素仅部分重叠，因此根据选择功能性和结构性措施作为主要终点，试验纳入标准、功率计算和协变量调整应有所不同。

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引用次数: 0

Bilateral Retinal Whitening in Methanol Poisoning 甲醇中毒后双侧视网膜变白。

IF 5.7 Q1 OPHTHALMOLOGY

Ophthalmology. Retina

Pub Date : 2026-03-01 Epub Date: 2025-07-15 DOI: 10.1016/j.oret.2025.06.012

Vanaja Jain MD, Nawazish Shaikh MD, DNB, Tushar Sharma MD

引用次数: 0

Ultra-widefield Imaging and Peripheral OCT of a Retinal Tuft 视网膜丛的超宽视场成像和外周OCT。

IF 5.7 Q1 OPHTHALMOLOGY

Ophthalmology. Retina

Pub Date : 2026-03-01 Epub Date: 2025-07-23 DOI: 10.1016/j.oret.2025.06.015

Alessandro Feo MD , Shahin Faghihi MD , David Sarraf MD

引用次数: 0

Re: Szeto et al: Macular Hole Closure by Internal Limiting Membrane Flap without Gas Tamponade versus Conventional Surgery. Re: Szeto等：无气体填塞的内限制膜瓣封闭黄斑孔与常规手术的比较。

IF 5.7 Q1 OPHTHALMOLOGY

Ophthalmology. Retina

Pub Date : 2026-02-28 DOI: 10.1016/j.oret.2026.02.007

Lorenzo Iuliano, Daniele Veritti, Paolo Lanzetta

引用次数: 0

Re: Barresi et al: Surgical and Observational Outcomes in Optic Pit Maculopathy: A Comparative Analysis of Pediatric and Adult Populations (Ophthalmol Retina. 2026;10:445-454). Re: Barresi et al .：视网膜黄斑窝病的手术治疗和观察结果：儿童和成人人群的比较分析（眼视网膜杂志，2006;10:45 -454）。

IF 5.7 Q1 OPHTHALMOLOGY

Ophthalmology. Retina

Pub Date : 2026-02-26 DOI: 10.1016/j.oret.2026.02.005

Dhananjay Shukla

引用次数: 0

Capturing the Mizuo-Nakamura Phenomenon with Ultra-Widefield Fundus Photography. 用超广角眼底摄影捕捉水谷-中村现象。

IF 5.7 Q1 OPHTHALMOLOGY

Ophthalmology. Retina

Pub Date : 2026-02-26 DOI: 10.1016/j.oret.2026.02.010

Daniel Ferreira Cardoso, Pedro Moreira Martins, Carolina Madeira

引用次数: 0

Long Term Anatomic and Visual Outcomes of Surgery for Rhegmatogenous Retinal Detachment in Young Adult Patients. 年轻成人孔源性视网膜脱离手术的长期解剖学和视力结果。

IF 5.7 Q1 OPHTHALMOLOGY

Ophthalmology. Retina

Pub Date : 2026-02-26 DOI: 10.1016/j.oret.2026.02.015

Jin Kyun Oh, Michael Y Zhao, Jesse D Sengillo, Harry W Flynn

Objective: To evaluate long-term anatomic and visual outcomes of primary surgical repair for rhegmatogenous retinal detachment (RRD) in young adult patients and to identify factors associated with visual and anatomic success.

Design: Retrospective cohort study.

Participants: 238 patients (median age 26.6 years, 45.4% male, 54.6% female).

Methods: Patients from a single tertiary academic medical center undergoing primary RRD repair between January 1, 2010, and August 1, 2024, were reviewed. Demographic data, pre-operative risk factors and examination, surgical technique, post-operative visual outcomes, single surgery anatomic reattachment rates both at 12 months and at most recent evaluation, and fellow-eye outcomes were recorded. Continuous variables were compared using analysis of variance or independent t tests, and categorical variables were compared using chi-square testing. Kaplan-Meier survival analysis assessed durability of single-surgery success and cumulative risk of fellow-eye intervention.

Main outcome measures: Single-surgery anatomic success at 12 months, additional retinal reattachment surgery, and fellow-eye intervention.

Results: Among 238 eligible patients (median age, 26.6 years; median follow-up, 42.3 months), primary scleral buckle (SB) was performed in 71.8%, combined pars plana vitrectomy/scleral buckle (PPV/SB) in 25.6%, and primary vitrectomy (PPV) in 2.1%. Overall single-surgery success at 12 months was 80.3% (82.4% for SB, 75.4% for PPV/SB, 80.0% for PPV; p=0.45). Median BCVA improved from 0.301 logMAR (≈20/40) preoperatively to 0.176 logMAR (≈20/30) at both 12 months and at final follow-up (p<0.05). Primary scleral buckle (odds ratio 4.30; 95% CI 2.33-7.92) and macula-on status (odds ratio 9.31, 95% CI 4.99-17.36) were independently associated with achieving BCVA ≤20/40. Kaplan-Meier analysis demonstrated that most anatomic failures occurred within the first postoperative year, with sustained stability through 15 years. Fellow-eye intervention occurred in 26.9% of patients during follow-up.

Conclusions: In young adults with RRD, primary surgical repair yields favorable long-term anatomic and visual outcomes, with failures clustering early after surgery. Primary scleral buckling remains an effective approach in this population. Ongoing fellow-eye surveillance is warranted given the cumulative risk of subsequent intervention.

目的：评价年轻成人孔源性视网膜脱离（RRD）初级手术修复的长期解剖和视力结果，并确定影响视力和解剖成功的因素。设计：回顾性队列研究。参与者：238例患者（中位年龄26.6岁，45.4%男性，54.6%女性）。方法：对2010年1月1日至2024年8月1日在某三级学术医疗中心进行RRD初级修复的患者进行回顾性分析。记录人口统计资料、术前危险因素和检查、手术技术、术后视力结果、12个月和最近一次评估时的单次手术解剖再附着率以及其他视力结果。连续变量的比较采用方差分析或独立t检验，分类变量的比较采用卡方检验。Kaplan-Meier生存分析评估单次手术成功的持久性和同眼干预的累积风险。主要结局指标：12个月时单次手术解剖成功，额外的视网膜再植手术和同眼干预。结果：在238例符合条件的患者中（中位年龄26.6岁，中位随访42.3个月），行一期巩膜扣环（SB）的占71.8%，行玻璃体切割/巩膜扣环联合（PPV/SB）的占25.6%，行一期玻璃体切除（PPV）的占2.1%。12个月的总单次手术成功率为80.3% （SB为82.4%，PPV/SB为75.4%，PPV为80.0%,p=0.45）。中位BCVA从术前的0.301 logMAR（≈20/40）改善到12个月和最终随访时的0.176 logMAR（≈20/30）。结论：在年轻RRD患者中，初级手术修复可获得良好的长期解剖和视力结果，手术后早期出现失败。在这一人群中，初级巩膜屈曲仍然是有效的治疗方法。鉴于后续干预的累积风险，有必要进行同伴眼监测。

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引用次数: 0

Tomographic Biomarkers Differ by Progression Risk to Late Macular Degeneration. 层析成像生物标志物因晚期黄斑变性的进展风险而不同。

IF 5.7 Q1 OPHTHALMOLOGY

Ophthalmology. Retina

Pub Date : 2026-02-24 DOI: 10.1016/j.oret.2026.02.011

Enrico Bernardi, Usha Chakravarthy, Katherine A Muldrew, Ruth E Hogg, David M Wright, Martin Zinkernagel, Tunde Peto, Lajos Csincsik

引用次数: 0

Vertical Henle Fiber Hyperreflective Line and Angular Sign of Henle Fiber Layer Hyperreflectivity After Blunt Ocular Trauma. 钝性眼外伤后垂直Henle纤维高反射率线及Henle纤维层高反射率的角征。

IF 5.7 Q1 OPHTHALMOLOGY

Ophthalmology. Retina

Pub Date : 2026-02-24 DOI: 10.1016/j.oret.2026.01.021

Nicola Sagurski, Lorenzo Ferro Desideri, Martin Zinkernagel

引用次数: 0

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