随机试验评估纳米滴器装置对儿童瞳孔散大及睫状肌麻痹的疗效。
Randomized Trial to Evaluate the Efficacy of the Nanodropper Device for Pupillary Dilation and Cycloplegia in Children.
机构信息
Department of Ophthalmology, University of California, San Francisco, San Francisco, California.
Department of Ophthalmology, University of California, San Francisco, San Francisco, California.
出版信息
Ophthalmology. 2023 Mar;130(3):324-330. doi: 10.1016/j.ophtha.2022.10.016. Epub 2022 Oct 22.
PURPOSE
We evaluated the noninferiority of 10.4 μl of eye drops eluted with a commercially available eye drop adapter, the Nanodropper (Nanodropper, Inc), on pupillary dilation and cycloplegia in children compared with the standard of care (SOC), 50 μl of eye drops.
DESIGN
Prospective randomized trial.
PARTICIPANTS
Pediatric patients scheduled for routine pupillary dilation at the University of California, San Francisco, at the Pediatric Ophthalmology Clinic were enrolled. Each participant provided 1 eye for the intervention group (Nanodropper) and 1 eye for the control group (SOC).
METHODS
Participants were randomized to receive small-volume dilating drops in 1 eye (Nanodropper) and SOC dilating drops in the other eye. Dilation was performed using 1 drop each of 1% cyclopentolate, 1% tropicamide, and 2.5% phenylephrine. Refraction and pupillometry were obtained before and 30 minutes after dilation. A noninferiority analysis was performed to assess change from before to after dilation in spherical equivalent and in pupil constriction percentage and maximum pupil diameter after dilation.
MAIN OUTCOME MEASURES
Spherical equivalent, maximum pupil diameter, and pupil constriction percentage.
RESULTS
One hundred eyes of 50 patients were included, with a mean ± standard deviation age of 9 ± 3 years. After controlling for baseline measurements, the spherical equivalent after dilation was 0.05 diopter (D) more (95% confidence interval [CI], -0.28 to 0.37 D) in the Nanodropper arm, which did not achieve noninferiority. Maximum pupil diameter after dilation was lower in the Nanodropper group (mean, -0.01 mm; 95% CI, -0.20 to -0.03), which did achieve noninferiority. Constriction percentage after dilation was 0.57 percentage points more (95% CI, -1.38 to 2.51 percentage points) in the Nanodropper group, which did not achieve noninferiority.
CONCLUSIONS
Administration of eye drops using a small-volume adapter demonstrated similar efficacy to SOC in a pediatric population. Strict noninferiority was met only for pupillary dilation and not for cycloplegia or constriction percentage; however, the small differences in the effect of the Nanodropper versus SOC on all primary outcomes were not clinically significant. We conclude that small-volume eye drops have the potential to decrease unnecessary medical waste and medication toxicity while maintaining therapeutic effect.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
目的
我们评估了使用市售滴眼器适配器 Nanodropper（Nanodropper，Inc.）洗脱的 10.4μl 滴眼液与标准护理（SOC）相比，在儿童瞳孔散大及睫状肌麻痹方面的非劣效性，SOC 为 50μl 滴眼液。
设计
前瞻性随机试验。
参与者
在加利福尼亚大学旧金山分校小儿眼科诊所，我们招募了计划进行常规瞳孔扩张的儿科患者。每位参与者的 1 只眼接受干预组（Nanodropper），另 1 只眼接受对照组（SOC）。
方法
参与者被随机分配至 1 只眼接受小体积散瞳滴剂（Nanodropper），另 1 只眼接受 SOC 散瞳滴剂。散瞳使用 1%环戊通、1%托吡卡胺和 2.5%苯肾上腺素各 1 滴。散瞳前和散瞳后 30 分钟分别进行屈光和瞳孔测量。进行非劣效性分析以评估散瞳前后等效球镜度数、瞳孔收缩百分比和散瞳后最大瞳孔直径的变化。
主要观察指标
等效球镜度数、最大瞳孔直径、瞳孔收缩百分比。
结果
共纳入 50 例患者的 100 只眼，平均年龄±标准差为 9±3 岁。在控制基线测量值后，Nanodropper 组散瞳后等效球镜度数增加 0.05 屈光度（95%置信区间，-0.28 至 0.37 D），未达到非劣效性。Nanodropper 组散瞳后最大瞳孔直径较低（平均，-0.01mm；95%置信区间，-0.20 至 -0.03），达到非劣效性。散瞳后瞳孔收缩百分比增加 0.57 个百分点（95%置信区间，-1.38 至 2.51 个百分点），未达到非劣效性。
结论
在儿科人群中，使用小体积适配器滴眼与 SOC 相比具有相似的疗效。仅在瞳孔散大方面严格达到非劣效性，而在睫状肌麻痹或收缩百分比方面未达到非劣效性；然而，Nanodropper 与 SOC 对所有主要结局的影响差异较小，无临床意义。我们的结论是，小体积滴眼液具有减少不必要的医疗废物和药物毒性的潜力，同时保持治疗效果。
金融披露（Financial Disclosure）：参考文献后可能存在专有或商业披露。
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