Table 1.
Overview of the Study Design and When Specific Diagnostic Occurred During the Screening, Study Period, and 1-Week Follow-up Visits
| Screening | Baseline/Day 0 | Week 1 | ||||
|---|---|---|---|---|---|---|
| Procedure | MPD Off | MPD Off | MPD On, Negative Pressure off | MPD on, Negative Pressure on | MPD Off | MPD Off |
| MPD check and sensitivity to pneumatonometry | X | |||||
| Informed consent | X | |||||
| Manifest refraction | OU | OU | ||||
| BCVA | OU | OU | ||||
| SLE | OU | OU | ||||
| OPTIC nerve assessment (OCT RNFL) | OU | OU | ||||
| Reichert model 30 pneumatonometry | OU1 | OU | OU | OU | OU2 | |
| CH via ORA | OU | OU | ||||
| Visual field | OU | OU | ||||
| Subjective assessment | X | X | X | |||
| Adverse event assessment | X | X | X | X | ||
1
Control eyes will not receive application of negative pressure.
2
Measured with MPD off only, one measurement.
Abbreviations: X = action performed; blank spaces = not performed; BCVA = best-corrected visual acuity; SLE = slit lamp examination; OCT RNFL = optical coherence tomography retinal nerve fiber layer; ORA = ocular response analyzer; OU = both eyes.