Table 4.
The Nature and Incidence of Adverse Events
| N (%) | Seriousa | Device Related | Status | |
|---|---|---|---|---|
| Layered hyphema ≥1mm | 7 (4.6%) | No | Yes | Recovered spontaneously without sequel |
| IOP increase ≥10 mmHg above baseline at ≥1 month | 3 (2.0%) | No | Yes | Recovered without sequel with hypotensive medication added |
| Blepharitis | 2 (1.3%) | No | No | Recovered spontaneously without sequel |
| Clinically significant cystoid macular edema | 1 (0.7%) | No | No | Ongoing, on topical steroid |
| Internal hordeolum | 1 (0.7%) | No | No | Ongoing with treatment |
| Keratoconjunctivitis sicca | 1 (0.7%) | No | No | Ongoing with treatment |
| Vitreous hemorrhage | 1 (0.7%) | No | No | Recovered spontaneously without sequel |
Notes: aAn adverse event that results in death, is life-threatening, requires in-patient hospitalization or prolongs existing hospitalization, necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, or is sight threatening.
Abbreviation: IOP, intraocular pressure.