Rathika Kandasamy1,2, Marios Constantinou1, Sophie Rogers1, Sukhpal S Sandhu1,2, Sanjeewa S Wickremasinghe1,2, Salmaan Al-Qureshi1,2, Lyndell L Lim1,2
Purpose: This trial aimed to compare the differences in visual and anatomical outcomes when either intravitreous bevacizumab (BVB) 1.25mg or triam- cinolone acetonide (TA) 4 mg was administered during cataract surgery to patients with diabetic macula oedema (DME). Method: Prospective, double-masked clinical trial. Patients with visually signiﬁcant cataracts and centre- involving DME (either concurrent or prior) were ran- domized (1:1) to receive either intravitreous BVB or TA at the time of cataract surgery and as required at subsequent review. Primary end-points were changes in best corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline. The 6-month results of this trial are presented here.
Results: 58 patients (61 eyes) were recruited from the Royal Victorian Eye and Ear Hospital, Melbourne. BCVA and CMT were not signiﬁcantly different between groups at baseline (P > 0.2). Both groups demonstrated improved visual outcomes at 6 months, with the TA group gaining +21.4 letters (95% conﬁ- dence interval [CI] +14.5, +28.4) versus +17.3 (CI +12.1, +22.6) in BVB group, despite there being no signiﬁcant difference between groups (P = 0.035). At 6 months, a signiﬁcant anatomical improvement was noted in the TA group with reduction in CMT (-51.4μm [CI −98.2, −4.7]) versus thickening in BVB group (+15.6μm [CI −26.4, +57.7]) (P = 0.035).
Conclusion: Intraoperative use of both BVB and TA
improved post-operative visual outcomes in patients with DME. However, a sustained anatomic improve- ment was only demonstrated in the TA group. Micro- structural variations between the groups may partially account for these ﬁndings.