Table 2 Evaluation schedule
Visit no | Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 |
|---|---|---|---|---|---|---|---|
Screening | Baseline | EOS | |||||
Visit weeks | M-1 | 0 | W2 ± 7D | W12 ± 14D | W24 ± 14D | W36 ± 14D | W48 ± 14D |
Informed consent/assignment of screening number | ○ | ||||||
Demographic information | ○ | ||||||
Height/weight measurement | ○ | ○ | ○ | ||||
Physical examination | ○ | ○ | ○ | ○ | ○ | ||
Medical/medication history | ○ | ○ | |||||
Inclusion/exclusion criteria review | ○ | ○ | |||||
Randomization | ○ | ||||||
Investigational device training | ○ | ○ | |||||
Prescription of investigational device | ○ | ○ | ○ | ○ | |||
Lifestyle questionnaire | ○ | ○ | ○ | ○ | ○ | ||
Myopia history of parents | ○ | ||||||
Spherical equivalent refractive error | ○ | ○ | ○ | ○ | |||
Axial length | ○ | ○ | ○ | ○ | ○ | ○ | |
Best-corrected visual acuity | ○ | ○ | △ | △ | |||
Ophthalmic examination (fundus examination; slit lamp examination) | ○ | ○ | △ | △ | △ | △ | |
Strabismus | ○ | ○ | △ | △ | △ | △ | |
Intraocular pressure | ○ | ○ | △ | △ | △ | △ | |
Adverse events | ○ | ○ | ○ | ○ | ○ | ○ | |
Concomitant medications/therapies | ○ | ○ | ○ | ○ | ○ | ○ | |
Adherence | ○ | ○ | ○ | ○ |