A randomized clinical trial using cyclopentolate and tropicamide to compare cycloplegic refraction in Chinese young adults with dark irises

BACKGROUND: To evaluate the necessity of cycloplegia for epidemiological studies of refraction in Chinese young adults (aged 17-22 years) with dark irises, and to compare the cycloplegic effects of 1% cyclopentolate and 0.5% tropicamide in them. METHODS: A total of 300 young adults (108 males and 192 females) aged 17 to 22 years (mean 19.03 ± 1.01) were recruited from Tianjin Medical University from November 2019 to January 2020. Participants were randomly divided into two groups. In the cyclopentolate group, two drops of 1% cyclopentolate eye drop were administrated (one drop every 5 min), followed by autorefraction and subjective refraction 30 to 45 min later. In the tropicamide group, four drops of 1% Mydrin P (Tropicamide 0.5%, phenylephrine HCl 0.5%) eye drop were given (one drop every 5 min), followed by autorefraction and subjective refraction 20 to 30 min later. The participants and the examiners were masked to the medication. Distance visual acuity, intraocular pressure (IOP), non-cycloplegic and cycloplegic autorefraction (Topcon KR-800, Topcon Co. Tokyo, Japan), non-cycloplegic and cycloplegic subjective refraction and ocular biometry (Lenstar LS-900) were performed. RESULTS: The values of spherical equivalent (SE) and sphere component were significantly different before and after cycloplegia in the cyclopentolate group and the tropicamide group (p < 0.05). The mean difference between noncycloplegic and cycloplegic autorefraction SE was 0.39 D (±0.66 D) in the cyclopentolate group and 0.39 D (±0.34 D) in the tropicamide group. There was no significant difference in the change of SE and sphere component after cycloplegia between the cyclopentolate group and the tropicamide group (p > 0.05). In each group, no significant difference was found between autorefraction and subjective refraction after cycloplegia (p > 0.05). We also found that more positive or less negative cycloplegic refraction was associated with the higher difference in SE in each group. CONCLUSIONS: Cycloplegic refractions were generally more positive or less negative than non-cycloplegic refractions. It is necessary to perform cycloplegia for Chinese young adults with dark irises to obtain accurate refractive errors. We suggest that cycloplegic autorefraction using tropicamide may be considered as a reliable method for epidemiological studies of refraction in Chinese young adults with dark irises. TRIAL REGISTRATION: The study was registered on September 7, 2019 (Registration number: ChiCTR1900025774 ).