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 |
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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 |
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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. |
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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) |
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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. |
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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. |