Abstract
Purpose :
In an prospective multicenter randomised placebo-controlled trial we studied if the adjuvant use of intravitreal dexamethasone in the treatment of patients with suspected bacterial endophthalmitis after phacoemulsification would lead to a better functional outcome.
Methods :
Patients with a suspected bacterial endophthalmitis after phacoemulsification were asked to participate in this study. A diagnostic vitreous biopsy was taken and the patients received intravitreal injections of 400 microgram dexamethasone without preservatives or placebo, plus 0.2 mg vancomycin and 0.05 mg gentamicin. Injections of Vancomycin and either placebo or dexamethasone were repeated after 3 or 4 days. Primary outcome was best corrected visual acuity converted to LogMAR at one year. Logistical regression analysis was performed with several variables: treatment center, interval after fako, pain, presenting visual acuity, presence of hypopion and cultured pathogen.
Results :
We performed an intention to treat analysis of 138 patients (71 placebo, 67 dexamethasone) with last observation carried forward (LOCF). Patients with presenting vision of Light Perception only (LP+): 16 in the placebo group, 17 in the dexametasone group. 100 patients (73%) were culture-positive, with 9 gram-negatives, and as grampositives 4 enterococci faecalis, 5 pneumococci, 3 hemolytic streptococci, 9 staph aureaus, 9 miscelleneous and 61 coagulase-negative staphs. 15 patients had a protocol violation: first injection dexamethasone, second injection placebo: n=2; second injection missing: n=7 (placebo: 2; dexa: 5); follow up less than 3 months with LOCF : n=8. Evisceration/enucleation in 9 patients (6 placebo, 3 dexa); LP negative in 4 patients (4 placebo, 4 dexa). Mean final BCVA in patients receiving dexamethasone (0.34 ± 0.63) did not differ statistically significantly (p= 0.72, Mann-Whitney U test) with the mean final BCVA of patients receiving placebo (LogMAR 0.23 ± 0.44). None of the variables had a statistically significant effect on the (lack of) difference in visual outcome between the groups.
Conclusions :
The adjuvant use of intravitreal dexamethasone to intravitreal antibiotics did not lead to a better functional outcome in patients treated for suspected bacterial postfako endophthalmitis.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.