Table 3

Expected adverse events

Visual acuity loss of vision (any of the following):
  • Irreversible loss of 10 ETDRS letters of logarithm of the mean angle of resolution visual acuity

  • Loss of two or more stages of categorical visual acuity measurement (count fingers, hand motion, light perception, no light perception)

  • Any loss to no light perception

Intervention 1
Medical treatment*
Intervention 2
Trabeculectomy with mitomycin C
Redness, stinging, itching, transient blurred vision, eyes watering, ocular discomfort, allergy, eyelash growth, change in skin colour around eye, change in iris colour, shortness of breath, unpleasant taste in mouth, dry mouth, fatigue, kidney stones, skin rash, cataract formation and retinal detachment*Discomfort, blurred vision, corneal epithelial defect, conjunctival button-hole, flap dehiscence, intraocular pressure too low, transient choroidal effusion, suprachoroidal haemorrhage, hyphema, early bleb leak, late bleb leak, shallow anterior chamber (grades 1–3), iris incarceration, persistent uveitis, transient or permanent ptosis, macular oedema, malignant glaucoma, corneal decompensation, cataract formation and retinal detachment, bleb infection, bleb related endophthalmitis, permanent severe loss of vision at time of surgery (<1/500), bleeding in the eye, broad complex tachycardia while under general anaesthetic, postoperative dizziness
  • *In some case, these symptoms may be due to preservatives in the drops—if this is the case, preservative free drops can be used.

  • These are based on knowledge of adverse events associated with augmented trabeculectomy and the relevant product information documented in the summary of product characteristics (SmPC). The latest online version of the appropriate SmPC will be considered in the assessment of an adverse event.