Efficacy and Safety of Bendazol Eye Drop Atomization in Slowing Myopia Progression in Children: A Randomized, Double-Blind, Placebo-Controlled Trial.

Abstract

Objective: This study aimed to assess the efficacy and safety of bendazol eye drop atomization in controlling the progression of myopia in children through a randomized, double-blind, placebo-controlled clinical trial.

Methods: From May 2022 to August 2023, children aged 8 to 12 years with myopia were recruited from the outpatient clinic at Ineye Hospital, Chengdu University of Traditional Chinese Medicine. Participants were randomly assigned to either the intervention group or the control group. All participants wore standard monofocal spectacles. The intervention group received ultrasonic atomization of bendazol eye drops for 10 minutes daily, while the control group received atomization of a placebo solution (identical in appearance but without bendazol) following the same protocol. The intervention period lasted for 24 weeks.

Results: When compared with the placebo group, the intervention group demonstrated a significantly slower increase in spherical equivalent at both 12 and 24 weeks, in addition to a significantly smaller increase in axial length at 24 weeks (all p < 0.05)..The tear film break-up time significantly increased post-intervention compared to baseline values in both groups (p < 0.05).

Conclusions: Bendazol eye drop atomization effectively delayed the progression of myopia in children, as evidenced by inhibition of spherical equivalent progression and axial elongation. The treatment improved tear film stability without affecting pupil diameter and demonstrated a favorable safety profile for clinical use.