Flowchart of the Study
MAY
Because of the COVID-19 pandemic and the associated sudden lockdown in Shanghai from March to May 2022, the number of participants at the 9-month visit and compliance with the treatment during the last 3 months in the intervention group were affected significantly when the children did not bring the devices home from school. A total of 65 of 139 children (46.8%) in the intervention group and 73 of 139 children (52.5%) in the control group did not attend the 9-month follow-up visit. For the last 3 months of the study, 32 of 139 children (23.0%) in the intervention group were able to continue the RLRL treatment. Despite this, we continued the trial and tried our best to complete the examination at the 12-month visit. Of 278 included children, 248 (89.2%) participated in the 12-month visit, consisting of 126 children (90.6%) in the intervention group and 122 children (87.8%) in the control group. The median compliance rate in the intervention group was 60.0% (IQR, 54.2%-64.8%).