A prospective multicentre randomized placebo-controlled superiority trial in patients with suspected bacterial endophthalmitis after cataract surgery on the adjuvant use of intravitreal dexamethasone to intravitreal antibiotics

作者：Manning Sonia; Ugahary Luana C.; Lindstedt Eric W.; Wubbels Rene J.; van Dissel Jaap T.; Jansen Jan T. . G.; Gan Ivan; van Goor Arnoud T.; Bennebroek Carlien A.; van der Werf Dymph J.; Ossewaarde-van Norel Annette; Nielsen Chris C. Mayland; Tilanus Mauk; van den Biesen Pieter R.; Schellekens Peter A.; La Heij Ellen; Faridpooya Koorosh; van Overdam Koen; Veckeneer Marc; van Meurs Jan C.^*

来源：Acta Ophthalmologica, 2018, 96(4): 348-355.

DOI：10.1111/aos.13610

• adjuvant intravitreal dexamethasone
• cataract surgery
• postoperative bacterial endophthalmitis
• randomized controlled trial

PurposeWe aimed to determine whether intravitreal dexamethasone as an adjuvant to intravitreal antibiotics is beneficial in the treatment of suspected bacterial endophthalmitis after cataract surgery.
MethodsRandomized, placebo-controlled superiority trial in three tertiary referral centres in the Netherlands. Patients with suspected bacterial endophthalmitis within 6weeks after cataract surgery were eligible. A diagnostic vitreous biopsy was taken for culture, and patients received intravitreal injections of 400g dexamethasone (without preservatives) or placebo, in addition to 0.2mg vancomycin and 0.05mg gentamicin. The vancomycin and dexamethasone or placebo injections were repeated once at day 3 or 4. Primary outcome measure was best-corrected visual acuity (BCVA) at 1year.
ResultsBetween 1 November 2004 and 1 March 2014 (excluding two interruptions totalling 20months), 324 eligible patients presented. A total of 167 patients (81 dexamethasone, 86 placebo) were available for the intention-to-treat analysis. Biopsies of 114 patients (68%) were culture-positive. Final BCVA did not differ between the dexamethasone and the placebo group (logMAR 0.310.58 versus 0.27 +/- 0.50; p=0.90), nor did the number of patients with final vision of no light perception (LP, 7 versus 13). Pain, corneal oedema, the absence of a red fundus reflex on presentation, LP on presentation and culture of virulent pathogens from biopsy were statistically significantly associated with an unfavourable visual outcome.
ConclusionIntravitreal dexamethasone without preservatives as an adjuvant to intravitreal antibiotics does not improve visual acuity (VA) in patients treated for suspected bacterial endophthalmitis after cataract surgery.

• 出版日期2018-6