European Society of Cataract and Refractive Surgeons’ Antibiotic Prophylaxis Study in Cataract Surgery

Inclusion criteria

Exclusion criteria

Phacoemulsification cataract surgery with IOL implantation as a single procedure without any additional surgery

Patients under 18 years of age

Patients allergic to penicillin and cephalosporins

Patients in long-term nursing homes

Pregnant patients

Treatment Assignment

The study was planned as 2 × 2 factorial design to test for the effects of two prophylactic antibiotics: (1) intracameral antibiotic injected at the conclusion of incident-free phacoemulsification cataract surgery and (2) topical levofloxacin in perioperative period (Fig. 33.1).

Fig. 33.1

Treatment assignment in ESCRS antibiotic prophylaxis study in cataract surgery.

The study medications are listed in Table 33.2.

Table 33.2

Study medications

Medication	Preoperative	Intraoperative	Postoperative
Povidone iodine. Topical	Povidone iodine 5%. Onto conjunctival sac and onto cornea for 1 min, 3 min before surgery	×	×
Levofloxacin Topical	Levofloxacin 0.5% One drop at 60 min and 30 min before surgery	×	Levofloxacin 0.5% One drop at 5 min interval commencing immediately after surgery One drop every 6 h for 6 days starting a day after the surgery
Cefuroxime Intracameral	x	Cefuroxime intracameral 1 mg in normal saline	×

Case Definition

A diagnosis of presumed endophthalmitis was made for any patient presenting with pain or loss of vision thought to be due to infection. Samples of aqueous and vitreous were collected from these patients and investigated using three microbiology methods—microscopy (Gram stain), culture, and molecular method (Polymerase Chain Reaction (PCR) using nonspecific microbial primers). Infective endophthalmitis was labeled if one of the three methods was positive. Each unproven case was reviewed for evidence of toxic anterior segment syndrome (TASS).

Results [2]

A total of 16,603 patients were recruited to the study, and the intent to treat (ITT) was 16,211 patients. This consisted of the following (Table 33.3).

Table 33.3

ITT in the ESCRS study

Group	Treatment	n
Group A	Placebo topical + no intracameral antibiotic	4050
Group B	Placebo topical + yes Intracameral antibiotic	4056
Group C	Levofloxacin topical + no intracameral antibiotic	4049
Group D	Levofloxacin topical + yes intracameral antibiotic	4052

Twenty-nine patients in the ESCRS study developed clinical endophthalmitis; 20 (69%) were microbiology positive, and they grew 23 microorganisms including two patients who developed polybacterial infection (Fig. 33.2). The highest incidence of endophthalmitis was seen in Group A (placebo topical; no intracameral antibiotic)—total endophthalmitis, 0.345% (95% CI, 0.119–0.579%), and proven endophthalmitis: 0.247% (95% CI, 0.118–0.453%). The lowest incidence of endophthalmitis was in group D (perioperative topical levofloxacin + intracameral cefuroxime)—total, 0.049% (95% CI, 0.006–0.181); proven: 0.025% (95% CI, 0.001–0.139).