title: 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.
abstract: BACKGROUND
  To 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).
  
  
  METHODS
  Prospective, single-masked, randomized clinical trial at The Royal Victorian Eye and Ear Hospital, Melbourne.
  
  
  METHODS
  Patients with clinically significant cataract and either centre-involving DME or DME treated within the previous 24 months.
  
  
  METHODS
  Participants were randomized 1:1 to receive intravitreous BVB 1.25 mg or TA 4 mg during cataract surgery, and at subsequent review if required over 6 months.
  
  
  METHODS
  Change in central macular thickness (CMT) and best corrected visual acuity at 6 months.
  
  
  RESULTS
  Forty-one patients (mean age 66.4 years, 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-µm reduction TA vs. +37.3-µm increase BVB, P = 0.006 over 6 months). 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 21 mmHg (12.5%) during the 6-month follow-up; BVB had no cases (P = 0.130). There were no cases of endophthalmitis in either group.
  
  
  CONCLUSIONS
  When administered at the time of cataract surgery in patients with DME, at 6 months 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.
authors.affiliation: Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital; Ophthalmology, University of Melbourne, Department of Surgery, Melbourne, Victoria, Australia.|Medical Retina Clinic, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.
authors.forename: Lyndell L
authors.initials: LL
authors.lastname: Lim
authors.affiliation: Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital; Ophthalmology, University of Melbourne, Department of Surgery, Melbourne, Victoria, Australia.
authors.forename: Julie L
authors.initials: JL
authors.lastname: Morrison
authors.affiliation: Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital; Ophthalmology, University of Melbourne, Department of Surgery, Melbourne, Victoria, Australia.
authors.forename: Marios
authors.initials: M
authors.lastname: Constantinou
authors.affiliation: Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital; Ophthalmology, University of Melbourne, Department of Surgery, Melbourne, Victoria, Australia.
authors.forename: Sophie
authors.initials: S
authors.lastname: Rogers
authors.affiliation: Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital; Ophthalmology, University of Melbourne, Department of Surgery, Melbourne, Victoria, Australia.|Medical Retina Clinic, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.
authors.forename: Sukhpal S
authors.initials: SS
authors.lastname: Sandhu
authors.affiliation: Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital; Ophthalmology, University of Melbourne, Department of Surgery, Melbourne, Victoria, Australia.|Medical Retina Clinic, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.
authors.forename: Sanjeewa S
authors.initials: SS
authors.lastname: Wickremasinghe
authors.affiliation: Yamagata University Faculty of Medicine, Yamagata, Japan.
authors.forename: Ryo
authors.initials: R
authors.lastname: Kawasaki
authors.affiliation: Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital; Ophthalmology, University of Melbourne, Department of Surgery, Melbourne, Victoria, Australia.|Medical Retina Clinic, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.
authors.forename: Salmaan
authors.initials: S
authors.lastname: Al-Qureshi
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000627:therapeutic use*; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D058449:Intravitreal Injections; D019654:Lens Implantation, Intraocular; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D018918:Phacoemulsification; D011446:Prospective Studies; D016037:Single-Blind Method; D014222:Triamcinolone Acetonide / Q000627:therapeutic use*; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000502:physiology
chemical_list: D020533:Angiogenesis Inhibitors; D005938:Glucocorticoids; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000068258:Bevacizumab; D014222:Triamcinolone Acetonide
keywords: bevacizumab; cataract surgery; diabetic macular oedema; randomized clinical trial; triamcinolone