Behavioral Intervention with Eye-Use Monitoring to Delay Myopia Onset and Progression in Children: A Cluster Randomized Trial

Purpose: To assess the efficacy of a behavioral intervention using Eye-Use Monitoring technology to delay the onset and progression of myopia in children. Design: A prospective, cluster-randomized, parallel-groups, examiner-masked, clinical trial (Chinese Clinical Trial Registry, ChiCTR2100052101). Participants: A total of 413 children from grades 2 to 4 in Shandong, China, from October 2021 to December 2023 were randomized by class into 3 groups: reminder and feedback (6 classes, 156 children), reminder-only (5 classes, 147 children), and control (3 classes, 110 children). Children with prior myopia control interventions, significant eye conditions, or a history of eye diseases were excluded. Methods: The reminder-only group received simultaneous vibration alerts for prolonged near work, close proximity, head tilt, or inadequate lighting. The reminder and feedback group received these alerts plus behavioral feedback, including praise, rewards, and weekly reports. The control group received no intervention. The intervention lasted 49 weeks, followed by a 49-week observation period without intervention. Main Outcome Measures: The primary outcome was the mean change in cycloplegic spherical equivalent (SE) at 49 weeks. Secondary outcomes included changes in axial length (AL), myopia incidence, rates of rapid myopic shift, participant compliance, and eye-use behaviors. Results: At 49 weeks, changes in SE and AL were least in the reminder and feedback group (SE: 0.52 ± 0.35 diopters [D] vs. 0.59 ± 0.43 D vs. 0.73 ± 0.48 D, AL: 0.30 ± 0.14 mm vs. 0.33 ± 0.16 mm vs. 0.40 ± 0.20 mm, in reminder and feedback group, reminder only group, and control group, respectively, both P < 0.001). Myopia incidence was lowest in the reminder and feedback group (13.3% vs. 21.6% vs. 27.8%, in reminder and feedback group, reminder only group, and control group, respectively, P < 0.05). However, differences diminished by the 98-week follow-up. Conclusions: This study demonstrated that the combination of Eye-Use Monitoring reminders and feedback on eye-use behaviors can effectively delay the onset and progression of myopia in children. However, sustained intervention may be necessary to maintain long-term benefits. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.