Diabetic Macular Edema at the time of Cataract Surgery trial: a prospective, randomized clinical trial of intravitreous bevacizumab versus triamcinolone in patients with diabetic macular oedema at the time of cataract surgery - preliminary 6 month results

作者：Lim Lyndell L^*; Morrison Julie L; Constantinou Marios; Rogers Sophie; Sandhu Sukhpal S; Wickremasinghe Sanjeewa S; Kawasaki Ryo; Al Qureshi Salmaan

来源：Clinical and Experimental Ophthalmology, 2016, 44(4): 233-242.

DOI：10.1111/ceo.12720

• bevacizumab
• cataract surgery
• diabetic macular oedema
• randomized clinical trial
• triamcinolone

BackgroundTo compare visual and anatomical outcomes between intravitreous bevacizumab (BVB, Avastin) and triamcinolone (TA, Triesence) when administered at the time of cataract surgery in patients with diabetic macular oedema (DME).
DesignProspective, single-masked, randomized clinical trial at The Royal Victorian Eye and Ear Hospital, Melbourne.
ParticipantsPatients with clinically significant cataract and either centre-involving DME or DME treated within the previous 24months.
MethodsParticipants were randomized 1:1 to receive intravitreous BVB 1.25mg or TA 4mg during cataract surgery, and at subsequent review if required over 6months.
Main Outcome MeasuresChange in central macular thickness (CMT) and best corrected visual acuity at 6months.
ResultsForty-one patients (mean age 66.4years, 73.2% male) were recruited. Visual acuity and CMT were similar between groups at baseline (P>0.2).After six months, both groups gained vision (mean +21.4 letters in TA group P<0.0001, +12.5 letters in BVB, P=0.002), with no significant difference between groups (P=0.085). In addition, 60.9% of eyes receiving TA achieved a VA of 6/12 compared to 73.3% in the BVB group (P=0.501). However, only TA was associated with a sustained reduction in CMT (-43.8-mu m reduction TA vs. +37.3-mu m increase BVB, P=0.006 over 6months). Following surgery, additional injections were required in 70.6% of participants in the BVB group, compared to 16.7% in the TA group (P<0.0001). Three patients in the TA group experienced a rise of IOP over 21mmHg (12.5%) during the 6-month follow-up; BVB had no cases (P=0.130). There were no cases of endophthalmitis in either group.
ConclusionsWhen administered at the time of cataract surgery in patients with DME, at 6months both TA and BVB improve visual acuity; however, only TA results in a sustained reduction in CMT. Further follow-up will determine whether this translates into better long-term visual outcomes in the TA group.

• 出版日期2016-6