دورية أكاديمية
أعرض في EDS

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

التفاصيل البيبلوغرافية
العنوان: Randomized Trial to Evaluate the Efficacy of the Nanodropper Device for Pupillary Dilation and Cycloplegia in Children.
المؤلفون: Hoppe CB; Department of Ophthalmology, University of California, San Francisco, San Francisco, California., Yonamine S; Department of Ophthalmology, University of California, San Francisco, San Francisco, California., Kao BW; Department of Ophthalmology, University of California, San Francisco, San Francisco, California., Turner ML; Department of Ophthalmology, University of California, San Francisco, San Francisco, California., Ou Y; Department of Ophthalmology, University of California, San Francisco, San Francisco, California., Han Y; Department of Ophthalmology, University of California, San Francisco, San Francisco, California., Keenan JD; Department of Ophthalmology, University of California, San Francisco, San Francisco, California., Oatts JT; Department of Ophthalmology, University of California, San Francisco, San Francisco, California. Electronic address: Julius.Oatts@ucsf.edu.
المصدر: Ophthalmology [Ophthalmology] 2023 Mar; Vol. 130 (3), pp. 324-330. Date of Electronic Publication: 2022 Oct 22.
نوع المنشور: Randomized Controlled Trial; Journal Article; Research Support, N.I.H., Extramural
اللغة: English
بيانات الدورية: Publisher: Elsevier Country of Publication: United States NLM ID: 7802443 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1549-4713 (Electronic) Linking ISSN: 01616420 NLM ISO Abbreviation: Ophthalmology Subsets: MEDLINE
أسماء مطبوعة: Publication: 2000- : New York : Elsevier
Original Publication: Rochester, Minn., American Academy of Ophthalmology.
مواضيع طبية MeSH: Mydriatics* , Presbyopia*, Humans ; Child ; Prospective Studies ; Dilatation ; Pupil ; Tropicamide ; Phenylephrine/pharmacology ; Ophthalmic Solutions
مستخلص: 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.
(Copyright © 2022 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
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معلومات مُعتمدة: K12 EY031372 United States EY NEI NIH HHS; P30 EY002162 United States EY NEI NIH HHS
فهرسة مساهمة: Keywords: Cycloplegia; Dilation; Eye drops; Health care utilization
المشرفين على المادة: 0 (Mydriatics)
N0A3Z5XTC6 (Tropicamide)
1WS297W6MV (Phenylephrine)
0 (Ophthalmic Solutions)
تواريخ الأحداث: Date Created: 20221024 Date Completed: 20230227 Latest Revision: 20240607
رمز التحديث: 20240607
مُعرف محوري في PubMed: PMC10108985
DOI: 10.1016/j.ophtha.2022.10.016
PMID: 36280185
قاعدة البيانات: MEDLINE
الوصف
تدمد:1549-4713
DOI:10.1016/j.ophtha.2022.10.016