Outcomes
cataract, hemorrhage
CATARACT, HEMORRHAGE, BACTERIAL ENDOPHTHALMITIS, ADVERSE EVENTS
The superior efficacy of the combination of SCTA and IVB compared to that of IVB alone, was the primary outcome of this three-months, randomized pilot study which will be achieved through between group analysis of the mean BCVA changes after the study was completed. Secondary outcomes were obtained from comparing the following between the study arms: (1) mean changes in BCVA, 4 weeks after baseline (2) proportion of patients with at least 15 ETDRS letter scores improvement in BCVA after twelve weeks (3) mean changes in CST and MV, four and twelve weeks after baseline (4) proportion of participants requiring additional treatments such as continuing monthly IVB injections, intravitreal corticosteroid injections and focal/grid laser photocoagulation based on expert diagnoses owing to persistent DME after three monthly injections. Persistent DME respectively defined as CST of at least 320 and 305 μm in the males and females was diagnosed through SD-OCT (Heidelberg, Spectralis) [Incidence of acute bacterial endophthalmitis, mean changes in IOP, four and twelve weeks after baseline, incidence of cataract progression and incidence of sub-conjunctival hemorrhage, were considered the possible adverse events.