Endophthalmitis Management Study- a prospective randomized clinical trial on postoperative endophthalmitis management in India: An interim analysis. EMS Report # 3

Abstract Purpose An interim analysis of Endophthalmitis Management Study - a multi-center study of acute postoperative endophthalmitis to examine the outcome of inflammation score (IS)- based treatment and identify an antibiotic alternate to ceftazidime with higher susceptibility to gram-negative bacilli. Methods Inflammation Score was measured on a 0 to 4 scale from presenting signs in four cardinal ocular tissues. The eyes with IS < 10 received vitreous biopsy + intravitreal antibiotics; eyes with IS ≥ 10 received vitrectomy + intravitreal antibiotics. These eyes were randomized to two intravitreal antibiotics combinations: vancomycin + ceftazidime and vancomycin + imipenem. Microbiology workup of undiluted vitreous included microscopy, culture-susceptibility, Sangers, and targeted next-generation sequencing. Results In three years, the EMS recruited 56.85% (248 of 436) patients, microbiology work-up was completed in 54.6% (238 of 436) people, and 94.4% (n = 234 of 248) had received cataract surgery. A 90-day follow-up was completed in 90.8% (168 of 185) of eligible people. In eyes with IS ≥ 20, the time to symptoms was shorter (5.8 ± 6.7 vs. 8.5 ± 9.1 days; p = 0.015), the need for additional treatment was higher (95.8% vs. 53.1%; p = 0.0267) and more often included vitreous procedures (44% vs. 6%; p = 0.012). Microbiology positivity was 55.9%; eyes with IS < 10 had a higher yield of gram-positive cocci (33.9% vs. 4.8%; p = 0.013). Vancomycin had good susceptibility to gram-positive cocci (95.7%); colistin had a better susceptibility to gram-negative bacilli (89.2%) than ceftazidime or imipenem (62.2% each). Conclusion Inflammation score could be a better guide to acute postoperative endophthalmitis treatment. Clinical Trial Registration. Clinical Trial Registry of India (CTRI/2019/02/017876)