Study period | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Enrollment | Allocation | Post-allocation | Close-out | ||||||||
Time point | T1 | 0 | T0 | T*1(1d) | T*2(1w) | T3(1 m) | T**4(2 m) | T5(3 m) | T6(6 m) | T7(12 m) | Tx |
Enrollment: | |||||||||||
Eligibility screen | X | ||||||||||
Informed consent | X | ||||||||||
Allocation | X | ||||||||||
Interventions: | |||||||||||
PPV | X | ||||||||||
IVC | X | X | X | ||||||||
Assessments: | |||||||||||
Demographics data | X | ||||||||||
Medical history | X | ||||||||||
Laboratory examination | X | ||||||||||
Eye examination | X | X | X | X | X | X | X | X | |||
BCVA | X | X | X | X | X | ||||||
IOP | X | X | X | X | X | X | X | X | |||
OCT | X | X | X | X | X | ||||||
OCTA | X | X | X | X | |||||||
Direct medical cost | X | ||||||||||
NEI-VFQ-25 | X | X | X | ||||||||
Adverse events | X | X | X | X | X | X | X | X |