Comparative Effectiveness of Tropicamide 1% Versus Cyclopentolate 1% in Cycloplegic Refraction: A Randomized Clinical Study

Abstract

Background: Accurate cycloplegic refraction is essential in children because active accommodation can mask true refractive error and influence spectacle prescription. Tropicamide 1% and Cyclopentolate 1% are commonly used cycloplegic agents, but they differ in cycloplegic strength, duration of action, recovery profile, and tolerability. Objective: To compare the cycloplegic effectiveness and adverse-effect profile of Tropicamide 1% versus Cyclopentolate 1% in children aged 5–15 years undergoing cycloplegic refraction. Methods: This randomized, parallel-group clinical study included 50 children with suspected refractive error, allocated equally to receive either Tropicamide 1% or Cyclopentolate 1%. Each participant received two drops of the assigned agent in each eye, five minutes apart. Baseline visual acuity and pre-cycloplegic objective refraction were recorded, followed by post-cycloplegic refraction after adequate dilation. Spherical equivalent was calculated, and the change from pre- to post-cycloplegic refraction was compared between groups. Ocular and systemic adverse effects were also recorded. Results: Baseline spherical equivalent values were comparable between groups. Cyclopentolate 1% produced a greater mean change in spherical equivalent than Tropicamide 1% in both eyes, with OD change of 1.164 ± 0.182 D versus 0.452 ± 0.130 D and OS change of 1.163 ± 0.182 D versus 0.452 ± 0.132 D, respectively (p < 0.001). Systemic symptoms were more frequent with Cyclopentolate 1% than Tropicamide 1% (100.0% vs 52.0%, p < 0.001). Conclusion: Both agents were effective for cycloplegic refraction, but Cyclopentolate 1% produced stronger cycloplegia, while Tropicamide 1% showed better tolerability. Agent selection should balance refractive accuracy with safety, comfort, and clinical context.