Incidence of side effects of topical atropine sulfate and cyclopentolate hydrochloride for cycloplegia in Japanese children: a multicenter study.

ABSTRACT

PURPOSE: To investigate the incidence rate and side effects of topical atropine sulfate and cyclopentolate hydrochloride for cycloplegia in children aged 15 years or under. METHODS: This prospective study had been conducted at 9 institutions between April 1, 2016 and March 31, 2017 in patients 15 years old or younger who received either atropine or cyclopentolate for refraction assessment. The investigation included patient's age, symptoms, and whether patients with side effects had any systemic diseases. RESULTS: A total of 811 patients (mean age ± SD, 4.6 ± 2.2 years) received atropine and 71 (8.8%) patients had side effects. Except in patients under two years old, 1% eye drops showed higher incidence rate of side effects than 0.5% and 0.25% eye drops. Side effects most frequently occurred following the initiation of the instillation on the first day. The symptoms included flush (29/71, 40.8%), fever (21/71, 30.0%), and both (11/71, 15.5%). A total of 2238 patients (5.7 ± 3.0 years) used cyclopentolate and 27 (1.2%) (4.0 ± 2.2 years) patients had side effects. The symptoms included drowsiness (10/27, 37.0%), red eye (4/27, 14.8%), fever (3/27, 11.1%), and flush (3/27, 11.1%). CONCLUSIONS: Atropine has a side effect incidence rate 7 times higher than the incidence rate of cyclopentolate. Flush and fever are the most common side effects of atropine and drowsiness is the main side effect of cyclopentolate. These findings should be noted when examining cycloplegic refraction to manage amblyopia and strabismus in children.