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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A case series described four patients (three men and one woman) aged 55−78 years, who experienced intraocular hypertension following treatment with dexamethasone for macular telangiectasia type I oedema as an off-label use, or for diabetic macular oedema [dosages not stated].
Case 1: A 72-year-old man, who had a baseline intraocular pressure (IOP) of 12mm Hg without treatment, was administered an intravitreal injection of dexamethasone in his left eye for diabetic macular oedema. Two months later, his IOP increased to 37mm Hg. He was treated with brinzolamide/brimonidine and bimatoprost/timolol eye drops, as well as oral acetazolamide for his elevated IOP. His IOP decreased to 16mm Hg a month later; however, in the meantime, he presented asthenia and paraesthesia due to...