Tropicamide Versus Cyclopentolate For Cycloplegic Refraction in Pediatric Patients with Brown Irides: A Randomized Clinical Trial

•Cycloplegic refraction remains the gold standard for determination of refractive errors in children and it is achieved by the use of pharmacological agents that temporarily paralyze the ciliary muscle.•In this study, we aim to compare the final cycloplegic refraction for the same patient using both cyclopentolate 1% and tropicamide 1% on two separate visits to assess whether tropicamide can be as effective and helpful to get a reliable refraction in children 3 to 16 years of age with brown irides.•To the best of our knowledge, only a few studies have compared the two agents. Some of these studies showed that cyclopentolate may reveal +0.11 to +0.39 diopters more hyperopia or less myopia than tropicamide, which is not of clinical significance.•We conclude that tropicamide can be considered a reliable and effective substitute to cyclopentolate for cycloplegic refraction in non-strabismic children. We believe it can make a great relief for busy clinical practices, increase patient and parent satisfaction, and have less effects on school attendance and performance. : To compare the final cycloplegic refraction of tropicamide 1% and cyclopentolate 1% in children 3 to 16 years of age with brown irides. : Randomized, controlled, multicenter prospective clinical trial. : Included patients were randomized to either cyclopentolate 1% or tropicamide 1% in the first visit with autorefraction measurements. Each subject underwent a second cycloplegic refraction using the other agent on a separate visit with a minimum of one-week interval and a maximum of 12 weeks. We measured the change in SE (ΔSE) for each eye by deducting the SE before cycloplegia from the SE after cycloplegia : A total of 185 eyes from 94 children aged 3 to 16 years old (average= 8.79 ±3.11 years) were included. The average SE of both eyes before cycloplegia was -0.082±4.8 diopter. The SE after instillation of cyclopentolate and tropicamide in both eyes was 1.07±5.2 and 0.96±5.1 respectively (P-value= 0.000). The average ΔSE after cycloplegia was 1.15±1.2 for cyclopentolate and 1.04±1.2 for tropicamide (P-value= 0.000). The difference between ΔSE of cyclopentolate and tropicamide was found statistically significant at 0.11±1.2 (P-value= 0.000), however clinically insignificant. The ΔSE between the two drops before and after cycloplegia in both eyes for all refractive error groups was clinically insignificant. The greatest effect of cyclopentolate and tropicamide was in hyperopic eyes with ΔSE of 1.