دورية أكاديمية
Randomized Trial to Evaluate the Efficacy of the Nanodropper Device for Pupillary Dilation and Cycloplegia in Children.
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.) |
References: | BMC Ophthalmol. 2017 May 22;17(1):78. (PMID: 28532424) Ophthalmology. 2020 Dec;127(12):1600-1602. (PMID: 32682622) Clin Ophthalmol. 2020 Jan 20;14:139-147. (PMID: 32021079) BMC Ophthalmol. 2014 Jun 13;14:79. (PMID: 24927769) J AAPOS. 2019 Feb;23(1):30.e1-30.e5. (PMID: 30641136) J Ocul Pharmacol Ther. 2006 Dec;22(6):477-82. (PMID: 17238816) Arch Ophthalmol. 1980 Jan;98(1):112-5. (PMID: 7352857) Expert Opin Drug Metab Toxicol. 2016 Nov;12(11):1279-1289. (PMID: 27398637) Ann Pharmacother. 2001 Dec;35(12):1633-7. (PMID: 11793633) Acta Ophthalmol Scand. 1997 Apr;75(2):178-80. (PMID: 9197568) Clin Ophthalmol. 2018 Nov 28;12:2451-2457. (PMID: 30568423) J Ocul Pharmacol Ther. 2014 Mar-Apr;30(2-3):163-9. (PMID: 24205938) Ophthalmology. 2020 Jun;127(6):724-730. (PMID: 31619358) Eye (Lond). 1991;5 ( Pt 5):615-9. (PMID: 1794430) Eur J Ophthalmol. 2007 May-Jun;17(3):341-9. (PMID: 17534814) Clin Ophthalmol. 2016 Dec 07;10:2433-2441. (PMID: 27994437) Surv Ophthalmol. 1982 Jan-Feb;26(4):207-18. (PMID: 7041308) J Cataract Refract Surg. 2020 Aug;46(8):1200-1201. (PMID: 32818332) Am J Ophthalmol. 1992 Feb 15;113(2):154-60. (PMID: 1347973) |
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 |
تدمد: | 1549-4713 |
---|---|
DOI: | 10.1016/j.ophtha.2022.10.016 |