Liu 2009.
| Methods |
Study design: parallel‐group randomized controlled trial Number randomized: 35 eyes of 35 participants total; not reported by intervention group Exclusions after randomization: none reported Losses to follow‐up: 3 participants (abstract stated no losses to follow‐up, but main text reported 32 participants had follow‐up) Unit of analysis: individual (1 eye per participant) Number analyzed: 32 participants total; 16 participants in trabeculectomy + MMC + AMT group; 16 participants in trabeculectomy + MMC group How were missing data handled?: 3 participants excluded from analysis Power calculation: not reported |
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| Participants |
Country: China Age: not reported Gender: not reported Inclusion criteria: refractory glaucoma Exclusion criteria: not reported Equivalence of baseline characteristics: yes |
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| Interventions |
Intervention 1: trabeculectomy + MMC + AMT Intervention 2: trabeculectomy + MMC Length of follow‐up: Planned: not reported Actual: 12 months |
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| Outcomes | Primary and secondary outcomes not distinguished Outcomes, as reported: postoperative IOP, number of antiglaucoma medications, bleb morphology, and complications Intervals at which outcomes assessed: 1 day, 1 week, and 1, 3, 6, 9, and 12 months |
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| Notes |
Publication type: published article Funding sources: not reported Disclosures of interest: not reported Trial registry: not registered Study period: not reported Subgroup analyses: none reported Publication language: Chinese Authors contacted for the number of participants lost to follow‐up at different follow‐up time points, but no response received |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Random sequence generation was not reported |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not reported |
| Masking of participants and personnel (performance bias) | Low risk | The study mentioned "double blinded". Because surgeons could not be masked, participants should have been masked |
| Masking of outcome assessment (detection bias) | High risk | It is not possible to mask outcome assessors, as devices can be seen during eye examination |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 3/35 participants were lost to follow‐up |
| Selective reporting (reporting bias) | High risk | Protocol was not available. Number of antiglaucoma medication and complications reported in the Results section were not mentioned in the Methods section |
| Other bias | Unclear risk | Did not report source of funding or conflict of interest. The study included 1 eye for each participant. No other potential bias identified |