Table 1.
Visit | Preobservation | Treatment | Postobservation | Drop-out | |||||||||||||
Week | 0 | 2 | 4 | 6 | 8 | 10 | 12 | 14 | 16 | 18 | 20 | 22 | 24 | 36 | 48 | ||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | ||
Allowable range (days) | 0–31 | 0 | ±4 | ±4 | ±4 | ±4 | ±4 | ±4 | ±4 | ±4 | ±4 | ±4 | ±4 | ±4 | ±14 | ±14 | +7 |
Informed consent | ● | ||||||||||||||||
Registration/randomisation | ● | ||||||||||||||||
Patient information | ● | ||||||||||||||||
TdES | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | |||||
Subjective symptoms review | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | |
Blood pressure measurement | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | 〇 | |
Blood test | ● | 〇 | |||||||||||||||
logMAR VA | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● |
ETDRS VA | ● | ● | ● | ● | ● | ● | ● | ||||||||||
HFA 10–2 | ● | ● | ● | ● | ● | ||||||||||||
HFA esterman | ● | ● | ● | ● | ● | ||||||||||||
OCT | ● | ● | ● | ● | ● | ● | |||||||||||
NEI VFQ-25 | ● | ● | ● | ● | ● | ||||||||||||
Slit lamp microscopy | ● | ● | ● | ● | ● | ● | ● | ||||||||||
IOP/fds | ● | ● | ● | ● | ● | ● | ● | ||||||||||
Pregnancy test | ● | 〇 | |||||||||||||||
Adverse event observation |
Black circles are items that must be performed. White circles are items to be performed only when the investigator deems it necessary.
ETDRS, Early Treatment Diabetic Retinopathy Study; fds, fundus examination; HFA, Humphrey field analyser; IOP, intraocular pressure; LogMAR, logarithm of the minimum angle of resolution; NEI VFQ-25, 25-item National Eye Institute Visual Function Questionnaire; OCT, optical coherence tomography; TdES, transdermal electrical stimulation; VA, visual acuity.