Skip to main content
. 2017 Feb 13;2017(2):CD006364. doi: 10.1002/14651858.CD006364.pub3

Sobaci 2003.

Methods Study design: randomized controlled trial
Exclusions and loss to follow‐up: eyes for which the surgical procedure was modified due to physician discretion at time of surgery were excluded from the study
Study follow‐up: 6 weeks
Participants Setting: Gülhane Military Medical Academy and Medical School Hospital, Ankara, Turkey
Enrolment: 644 eyes of 640 participants undergoing phacoemulsification cataract surgery
Age: group 1: 64.2 ± 14.3 years (range 43 to 87); group 2: 61.2 ± 14.2 years (range 40 to 81)
Gender: not reported
Inclusion criteria: people scheduled to undergo phacoemulsification surgery
Exclusion criteria: people with previous history of immunosuppressive treatment, diabetes mellitus, ocular surgery, recent infection, or inflammation
Interventions Intervention 1: balanced salt solution‐only irrigating infusion fluid (n = 322 eyes)
Intervention 2: balanced salt solution with antibiotics (vancomycin 20 mg/mL and gentamicin 8 mg/mL; 322 eyes)
General: interventions were given intraoperatively. Preoperative treatment, postoperative treatment, and follow‐up were identical for both groups.
Preoperative treatment: 1‐day course of topical ofloxacin 0.3% and diclofenac sodium 1 mg/mL 4 times a day; conjunctival smears were obtained just before povidone iodine instillation at time of surgery.
Surgical technique: phacoemulsification with a standard 3.2‐mm clear corneal incision, circular capsulotomy, and stop‐chop technique followed by foldable hydrophobic acrylic intraocular lens implantation; no sutures, subconjunctival antibiotics, or steroid injections were used.
Postoperative treatment: eyes were treated with ofloxacin 0.3%, dexamethasone 1 mg/mL, and indomethacin 0.1% drops with a 4‐week tapering dose; participants were discharged the day after surgery.
Outcomes Primary outcomes: 
 risk of postoperative endophthalmitis; 
 aqueous humor contamination during phacoemulsification
Participants were seen on days 2, 5, 10, 15, 30, and 45
Unit of analysis: the eye (both eyes of 4 participants were included separately in the analysis)
Notes Study dates: May 2000 to June 2002
Funding source: not reported
Publication language: English
The study authors reported the rate of postoperative endophthalmitis at their institution was 0.109%, but only 644 eyes were included in the study.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Patients were randomly allocated to irrigating infusion fluid containing either balanced salt solution (BSS)‐only (group 1; 322 eyes of 320 patients) or BSS with antibiotics (20 mg/ml vancomycin and 8 mg/ml gentamicin) (group 2; 322 eyes of 320 patients), according to the scheduled day of surgery, which was performed one after another. (1:1)."
Allocation concealment (selection bias) Unclear risk Method of allocation concealment not reported.
Masking of participants (performance bias) Unclear risk Masking of participants was not reported.
Masking of physicians and clinical care providers (performance bias) Unclear risk Masking of physicians was not reported.
Masking of outcome assessment (detection bias) Unclear risk Masking of outcome assessors was not reported.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Eyes for which the surgical procedure was modified due to physician discretion at time of surgery were excluded from the study. The number of excluded participants was not reported.
Selective reporting (reporting bias) Low risk Results were reported for both primary outcomes.
Other bias Low risk No other potential sources of bias identified.