Entezari 2007.
| Methods | Randomised double‐masked placebo controlled 3 months follow‐up Emmam Hossein Medical Center, Iran | |
| Participants | 31 participants; all men
Age: average age of 29.0±10.2 years (8 to 48)
Treatment group: 30.2±10.6 years
Control group: 28.0±10.9 years Treatment group: 16 participants Control group: 15 participants Inclusion criteria: 1. interval between trauma and admission less than 7 days; 2. eyes with normal fundus; and 3. indirect TON. Exclusion criteria: 1. penetrating trauma; 2. other accompanying ocular lesions that cause low visual acuity; 3. media haziness; 4. optic nerve avulsion and direct injuries; 5. eyes with TON that needed optic‐nerve decompression surgery; and 6. TON with blow‐out fracture. |
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| Interventions | Treatment group: 250 mg methylprednisolone intravenously every 6 hours for 3 days, then 1 mg/kg prednisolone orally for 14 days. Placebo group: 50 ml normal saline intravenously every 6 hours for 3 days, then placebo for 14 days. | |
| Outcomes | Primary outcome: final BCVA (LogMAR) Secondary outcome: 0.4 LogMAR decrease in final BCVA with respect to initial BCVA | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote p. 1268: " . . the patients were randomly assigned to the control and case groups . . " |
| Allocation concealment (selection bias) | Unclear risk | Quote p. 1268: " . . the patients were randomly assigned to the control and case groups according to simple randomization." |
| Blinding (performance bias and detection bias) Co‐investigators | Low risk | Quote p. 1268: "Complete eye examinations were done 1, 2, 3 days, 2 weeks, and 1 and 3 months by another co‐investigator, who was blinded to the codes. Another investigator had ordered the treatments." |
| Blinding (performance bias and detection bias) Participants | Low risk | Quote p. 1268: "The patients also did not know the type of treatment they were receiving." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote p. 1269: "All the patients were followed‐up for 3 months, and there were no missing data." |
| Selective reporting (reporting bias) | Low risk | The published report includes all the expected outcome measures for a trial of this nature. |
BCVA: best corrected visual acuity LogMAR: Logarithm of the Minimum Angle of Resolution TON: traumatic optic neuropathy