Comparison of tropicamide and cyclopentolate for cycloplegic refraction in children: A randomized clinical trial

Abstract

Background: Cycloplegic refraction is essential in pediatric ophthalmic practice to prevent underestimation of hyperopia and overestimation of myopia due to active accommodation. Although cyclopentolate 1% is commonly used for this purpose, it is associated with prolonged mydriasis and potential systemic side effects. Tropicamide 1%, with a shorter duration of action and better tolerability, may offer a practical alternative. This study aimed to compare the cycloplegic refractive outcomes of tropicamide 1% and cyclopentolate 1% in children. Materials and Methods: A prospective, randomized, two-period crossover study was conducted in 250 children (250 eyes) aged 6–18 years at a tertiary care center in Eastern India. Each participant underwent cycloplegic refraction with cyclopentolate 1% and tropicamide 1% in alternate sequence, separated by a one-week washout period. Spherical equivalent (SE) was recorded using automated refraction and retinoscopy. Carryover and period effects were assessed prior to treatment comparison. Paired t-tests were used to compare SE between agents, and agreement was evaluated using Bland–Altman analysis. Results: The mean spherical equivalent with cyclopentolate was −1.39 ± 2.83 D, compared with −1.41 ± 2.82 D with tropicamide. The mean within-subject difference (cyclopentolate − tropicamide) was +0.02 ± 0.18 D (p = 0.080), with a 95% confidence interval of −0.002 to +0.043 D. No significant carryover or period effects were observed. Age-wise analysis revealed no significant inter-agent differences. In refractive subgroup analysis, a statistically significant but clinically small difference was observed in hyperopic eyes. Bland–Altman analysis demonstrated a mean bias of +0.02 D, with 95% limits of agreement from −0.335 D to +0.375 D, indicating close agreement between the two agents. Conclusion: Tropicamide 1% provides spherical equivalent measurements that are closely comparable to those obtained with cyclopentolate 1% in children aged 6–18 years. Given its shorter duration of action and favorable safety profile, tropicamide may be considered a useful alternative for routine pediatric cycloplegic refraction, while cyclopentolate remains preferable when maximal cycloplegia is required.