Randomized Trial to Evaluate the Efficacy of the Nanodropper Device for Pupillary Dilation and Cycloplegia in Children

Ophthalmology Volume 130, Number 3, March 2023

中文摘要

本研究旨在評估一種新型小容量滴眼器套件「Nanodropper」對於幼童瞳孔擴張和消除調節反應的有效性。本研究將患者分為兩組，隨機將小容量擴瞳滴眼液和標準滴眼液分別注入兩只眼睛，之後進行檢查，並以三個指標評估治療效果：spherical equivalent、瞳孔收縮百分比和散瞳後最大瞳孔直徑。結果顯示，使用「Nanodropper」治療組的最大瞳孔直徑達到非劣效，但瞳孔收縮百分比和spherical equivalent等效度在統計上沒有達到非劣效，但無臨床意義。本研究認為，小容量滴眼液具有減少不必要的醫療浪費和藥物毒性的潛力，且有效性與標準滴眼液相近。

English Abstract

The article discusses a study conducted at the Pediatric Ophthalmology Clinic of the University of California, San Francisco, which aimed to evaluate the effectiveness of small-volume eye drops for pediatric pupillary dilation and cycloplegia using the Nanodropper. Participants were randomized to receive small-volume dilating drops in one eye and standard of care dilating drops in the other eye. A non-inferiority analysis was performed to assess changes from before to after dilation in spherical equivalent, pupil constriction percentage, and maximum pupil diameter after dilation. The Nanodropper achieved non-inferiority for maximum pupil diameter after dilation, but not for spherical equivalent or constriction percentage. However, the small differences in the effect of the Nanodropper versus standard of care on all primary outcomes were not clinically significant. The study concludes that small-volume eye drops have the potential to decrease unnecessary medical waste and medication toxicity while maintaining therapeutic effect. The article notes that larger eye-drop volumes may increase the likelihood of adverse medication effects, especially because topical medications that reach the nasolacrimal duct and nasopharynx can be absorbed systemically through the mucosa, avoiding first-pass metabolism. The study demonstrates that small-volume eye drops are similar to standard of care eye drops for pupillary dilation and cycloplegia in pediatric patients. Using smaller-volume eye drops has economic and health care system advantages, as it could result in cost savings for patients, health care providers, and the medical system.