Lee Daniel J, Scruggs Brittni A, Sánchez Erik, Thomas Merina, Faridi Ambar
Casey Eye Institute, Department of Ophthalmology, Oregon Health & Science University, Portland, OR, USA.
Present address: Department of Ophthalmology, Mayo Clinic, Rochester, MN, USA.
Ophthalmol Sci. 2022 Jun;2(2). doi: 10.1016/j.xops.2022.100115. Epub 2022 Jan 21.
To describe cases of significant vision loss following intravitreal aflibercept using pre-filled syringes (PFS) and to study the relationship between syringe design, injection speed, and injection force.
Retrospective case series and experimental study.
12 patients who received intravitreal aflibercept PFS.
All retina specialists (N=13) at Oregon Health & Science University and the Veterans Affairs Portland Medical Center were queried in December 2020 to report episodes of significant vision loss following aflibercept PFS use. Chart review was completed for all affected patients for demographics and pertinent ocular history. Using a commercially available force measuring system, injection force was measured for aflibercept PFS, ranibizumab PFS, and a tuberculin syringe at various injection speeds.
Number of significant vision loss episodes following aflibercept PFS use; average injection force (Newton, N) at various injection speeds across different syringes.
Ten specialists (76.9%) reported a perceived increase in post-injection vision loss with aflibercept PFS. Three specialists had no cases of vision loss. 16 events of light perception or worse vision immediately following aflibercept PFS use were reported. Chart review was available for 12 of these events. The indication for aflibercept was exudative age-related macular degeneration (N=8), diabetic macular edema (N=3), and central serous chorioretinopathy (N=1). The median age of affected patients was 71 years (range 49-94). Two patients were being treated for glaucoma (N=1) or ocular hypertension (N=1); one patient was a glaucoma suspect. Anterior chamber paracentesis was performed in four patients to normalize intraocular pressure (IOP) promptly. Laboratory experiments demonstrated that higher injection speeds were associated with higher injection forces for all syringe types. Injection forces were consistently greater with aflibercept PFS than with the ranibizumab PFS or tuberculin syringes (p < 0.0001).
Retina specialists within our institutions have noted numerous cases of severe transient vision loss with aflibercept PFS use. Some affected patients have reported increased injection-related anxiety. The average injection force may be greater with the aflibercept PFS when compared to other intravitreal anti-VEGF options. Additional clinical studies are needed to better understand how syringe design and fluid dynamics may contribute to post-injection vision loss.
描述使用预填充注射器（PFS）玻璃体内注射阿柏西普后出现严重视力丧失的病例，并研究注射器设计、注射速度和注射力之间的关系。
回顾性病例系列研究和实验研究。
12例接受玻璃体内注射阿柏西普PFS的患者。
2020年12月，对俄勒冈健康与科学大学以及波特兰退伍军人事务医疗中心的所有视网膜专科医生（共13人）进行询问，以报告使用阿柏西普PFS后出现严重视力丧失的情况。对所有受影响患者的病历进行回顾，以获取人口统计学信息和相关眼部病史。使用市售的测力系统，在不同注射速度下测量阿柏西普PFS、雷珠单抗PFS和结核菌素注射器的注射力。
使用阿柏西普PFS后严重视力丧失事件的数量；不同注射器在不同注射速度下的平均注射力（牛顿，N）。
10名专科医生（76.9%）报告使用阿柏西普PFS后注射后视力丧失有明显增加。3名专科医生没有视力丧失的病例。报告了16例在使用阿柏西普PFS后立即出现光感或更差视力的事件。其中12例事件有病历回顾资料。阿柏西普的适应证为渗出性年龄相关性黄斑变性（8例）、糖尿病性黄斑水肿（3例）和中心性浆液性脉络膜视网膜病变（1例）。受影响患者的中位年龄为71岁（范围49 - 94岁）。2例患者正在接受青光眼（1例）或高眼压症（1例）治疗；1例患者为青光眼可疑患者。4例患者进行了前房穿刺以迅速使眼压正常化。实验室实验表明，所有注射器类型中，较高的注射速度与较高的注射力相关。阿柏西普PFS的注射力始终大于雷珠单抗PFS或结核菌素注射器（p < 0.0001）。
我们机构内的视网膜专科医生注意到使用阿柏西普PFS后出现大量严重短暂视力丧失的病例。一些受影响的患者报告注射相关焦虑增加。与其他玻璃体内抗VEGF药物相比，阿柏西普PFS的平均注射力可能更大。需要进一步的临床研究，以更好地了解注射器设计和流体动力学如何导致注射后视力丧失。
