Department of Ophthalmology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan.
Department of Health Services Research, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Ophthalmology. 2023 Mar;130(3):256-264. doi: 10.1016/j.ophtha.2022.10.017. Epub 2022 Oct 26.
To investigate the risk of ocular adverse events after Coronavirus Disease 2019 (COVID-19) mRNA vaccination.
Matched cohort and self-controlled case series (SCCS) studies.
We used a population-based database of medical claims and vaccination records in a large Japanese city. In the matched cohort study, we identified individuals who received COVID-19 vaccination (BNT162b2) from February 2021 to September 2021. One control was selected from nonvaccinated individuals by matching time, date of birth, sex, Charlson comorbidity index, and the enrollment period for health insurance. In the SCCS study, we analyzed individuals who developed ocular adverse events.
In the matched cohort study, we applied the Kaplan-Meier estimator to estimate the cumulative incidence of ocular adverse events over 21 days after the first dose and 84 days after the second dose. In the SCCS method, we used conditional Poisson regression to estimate the incidence rate ratio (IRR) of ocular adverse events during the risk periods (0-21 days after the first dose and 0-84 days after the second dose) compared with the remaining periods.
Composite outcome of uveitis, scleritis, retinal vein occlusion (RVO), and optic neuritis.
There were 99 718 pairs eligible for the matched cohort study after the first dose (mean age, 69.3 years; male, 44%). The vaccinated and control groups developed 29 and 21 events, respectively, over 21 days after the first dose, and 79 and 28 events, respectively, over 84 days after the second dose. The differences in cumulative incidence (reference, the control group) were 2.9 (95% confidence interval, -14.5 to 19.1) events/100 000 persons and 51.3 (16.2-84.3) events/100 000 persons, respectively, for the first and second doses. The SCCS study showed the IRRs of 0.89 (0.62-1.28) and 0.89 (0.71-1.11) for the first and second doses, respectively.
The matched cohort analysis found an increased risk for the composite outcome after the second dose; however, the SCCS analysis showed no increased risk. Considering that the SCCS can cancel out time-invariant confounders, the current results suggest that COVID-19 vaccination is unlikely to causally increase the risk of ocular adverse events.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
调查 2019 年冠状病毒病（COVID-19）mRNA 疫苗接种后眼部不良事件的风险。
匹配队列研究和自身对照病例系列研究（SCCS）。
我们使用了日本一个大城市基于人群的医疗索赔和疫苗接种记录数据库。在匹配队列研究中，我们确定了 2021 年 2 月至 9 月期间接种 COVID-19 疫苗（BNT162b2）的个体。通过匹配时间、出生日期、性别、Charlson 合并症指数和医疗保险登记期，从未接种疫苗的个体中选择一名对照。在 SCCS 研究中，我们分析了发生眼部不良事件的个体。
在匹配队列研究中，我们应用 Kaplan-Meier 估计来估计第一剂后 21 天和第二剂后 84 天眼部不良事件的累积发生率。在 SCCS 方法中，我们使用条件泊松回归来估计风险期（第一剂后 0-21 天和第二剂后 0-84 天）与剩余期相比眼部不良事件的发病率比值（IRR）。
葡萄膜炎、巩膜炎、视网膜静脉阻塞（RVO）和视神经炎的复合结局。
第一剂后有 99718 对符合匹配队列研究条件（平均年龄 69.3 岁；男性 44%）。接种组和对照组在第一剂后 21 天分别发生 29 例和 21 例事件，在第二剂后 84 天分别发生 79 例和 28 例事件。累积发病率（参考，对照组）的差异分别为 2.9（95%置信区间，-14.5 至 19.1）/100000 人和 51.3（16.2-84.3）/100000 人，分别为第一剂和第二剂。SCCS 研究显示第一剂和第二剂的 IRR 分别为 0.89（0.62-1.28）和 0.89（0.71-1.11）。
匹配队列分析发现第二剂后复合结局的风险增加；然而，SCCS 分析并未显示风险增加。考虑到 SCCS 可以消除时间不变的混杂因素，目前的结果表明 COVID-19 疫苗接种不太可能导致眼部不良事件的风险增加。
参考文献后可能有专有或商业披露。
