Discontinuation criteria
Diabetic Retinopathy
ADVERSE EVENTS, SECONDARY, DIABETIC RETINOPATHY, COMPLICATIONS
When the subject offers to decline participation in the clinical trial or withdraws consent.When the subject is found to be ineligible for the subject after enrollment in the clinical trial.When it is difficult to continue the clinical trial due to exacerbation of complications.When it is difficult to continue the clinical trial due to adverse events.If pregnancy is found.If the entire clinical trial is discontinued.When other serious violations of the clinical trial protocol are found.When the necessity of discontinuation is recognized at the discretion of the investigator.The primary endpoint was the logarithm of the minimum angle of resolution (logMAR) visual acuity, and the secondary endpoints were changes in logMAR visual acuity, Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity, mean deviation value of HFA 10–2, and score of HFA monocular Esterman test scores. The incidence of adverse events (AEs; type, frequency, and severity) was investigated for evaluation of safety.Electrical stimulation was performed every 2 weeks for six sessions, and patients were assessed before TdES (baseline), 1 h after the end of treatment, and at 2 weeks after TdES. TdES treatment and examination schedule for this trial are shown in 