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.

PURPOSE: We aimed to determine whether intravitreal dexamethasone as an adjuvant to intravitreal antibiotics is beneficial in the treatment of suspected bacterial endophthalmitis after cataract surgery. METHODS: Randomized, placebo-controlled superiority trial in three tertiary referral centres in the Netherlands. Patients with suspected bacterial endophthalmitis within 6 weeks after cataract surgery were eligible. A diagnostic vitreous biopsy was taken for culture, and patients received intravitreal injections of 400 µg dexamethasone (without preservatives) or placebo, in addition to 0.2 mg vancomycin and 0.05 mg 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 1 year. RESULTS: Between 1 November 2004 and 1 March 2014 (excluding two interruptions totalling 20 months), 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 0.31 ± 0.58 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. CONCLUSION: Intravitreal 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.

Intravitreal dexamethasone as adjuvant in the treatment of postoperative endophthalmitis: a prospective randomized trial.

PURPOSE: To study whether intravitreal dexamethasone as adjuvant to intravitreal antibiotics improves the outcome in patients with suspected postoperative bacterial endophthalmitis. DESIGN: Prospective randomized clinical trial. SETTING: Tertiary referral center. PATIENT POPULATION: Twenty-nine consecutive patients with suspected postoperative bacterial endophthalmitis within 6 weeks of cataract surgery. INTERVENTION: Patients underwent a vitreous biopsy followed by intravitreal injection of antibiotics (0.2 mg vancomycin and 0.05 mg gentamicin) and 400 microg dexamethasone or placebo. After 3-4 days the intravitreal injection of antibiotics and dexamethasone or placebo was repeated. PRIMARY OUTCOME MEASURE: Snellen visual acuity at 3 and 12 months after treatment. RESULTS: In 20/29 patients (69%) the vitreous cultures were positive. 13/29 patients received dexamethasone. Seven patients had a functionally lost eye (final vision of hand movements or less), in four due to retinal detachment. Visual acuity tended to be better in the dexamethasone treated patients than in those given placebo, at both 3 months (P=0.055) and 12 months (P=0.080). CONCLUSION: This small prospective, placebo-controlled series showed a trend towards a better visual outcome in patients with suspected bacterial endophthalmitis when treatment with intravitreal antibiotics was combined with intravitreal dexamethasone. Our findings justify a larger multicenter randomized study.

Effect of intravitreal dexamethasone on vitreous vancomycin concentrations in patients with suspected postoperative bacterial endophthalmitis.

PURPOSE: To study intravitreal dexamethasone and vancomycin concentrations, when used together in patients with suspected postoperative bacterial endophthalmitis. Animal studies had suggested that dexamethasone might decrease the concentration of vancomycin. DESIGN: Prospective randomized clinical trial in a tertiary referral center. METHODS: Twenty-nine consecutive patients with suspected postoperative bacterial endophthalmitis underwent a vitreous biopsy followed by intravitreal injection of antibiotics (0.2 mg vancomycin, 0.05 mg gentamicin) and 400 mug dexamethasone or placebo. After 3-4 days, the intravitreal injection of antibiotics and dexamethasone or placebo was repeated. In 18 patients, a second biopsy was taken for repeat culture and measurement of vancomycin and dexamethasone concentrations. RESULTS: In 20/29 patients (69%) the first vitreous cultures were positive; the second culture was negative in all cases. Thirteen out of 29 patients received dexamethasone. Dexamethasone concentrations showed an average of 25 ng/ml 3 days after injection, with an estimated half-life of 5.5 h. Vancomycin concentrations in patients given dexamethasone tended to be higher compared with those in the placebo group (P=0.061). CONCLUSION: Intravitreal dexamethasone does not lead to decreased vancomycin concentrations, when given simultaneously in the treatment of patients with suspected bacterial endophthalmitis.