Table 3

Number of patients in the safety population experiencing adverse ocular events in the study eye from post-surgery until study completion

Adverse eventn (%)
Anterior chamber inflammation8 (30.8)
Visual acuity reduced8 (30.8)
Visual field defect7 (26.9)
Intraocular pressure increased*5 (19.2)
Lenticular opacities5 (19.2)
Hyphaema3 (11.5)
Conjunctival haemorrhage2 (7.7)
Eye pain2 (7.7)
Eye pruritus2 (7.7)
Cataract1 (3.8)
Cataract subcapsular1 (3.8)
Conjunctival oedema1 (3.8)
Corneal disorder1 (3.8)
Corneal oedema1 (3.8)
Cystoid macular oedema1 (3.8)
Detached Descemet’s membrane1 (3.8)
Glare1 (3.8)
Hypotony of eye1 (3.8)
Iatrogenic corectopia1 (3.8)
Macular fibrosis1 (3.8)
Posterior capsular opacification1 (3.8)
Punctate keratitis1 (3.8)
Vitreous haemorrhage1 (3.8)
Corneal abrasion1 (3.8)
Conjunctival foreign body1 (3.8)
  • *Only one patient had a mean intraocular pressure (IOP) increase, which fulfilled the protocol definition of substantial IOP increase (≥10 mmHg higher than screening IOP after the 1-month postoperative visit).

  • n= number of patients.