El‐Saied 2021.
Study characteristics | ||
Methods |
Study design: parallel‐group randomized controlled trial (2 participants both eyes included) Country: Egypt Number randomized: 20 eyes of 20 participants total; 10 eyes in each group Exclusions after randomization: not reported Losses to follow‐up: not reported Unit of analysis: eye Number analyzed: 20 eyes total; 10 eyes in trabeculectomy + Ex‐PRESS mini shunt + MMC group; 10 eyes in trabeculectomy + MMC group How were missing data handled? not reported Power calculation: the sample size was calculated using MedCalc 10.2.0.0, by referring to success rates of glaucoma surgeries for NVG from literature. The power and alpha were not reported. |
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Participants |
Mean age: 55.7(SD 5.6) years 55.4 (SD 5.8) years for trabeculectomy + Ex‐PRESS mini shunt group 56 (SD 5.3) years for trabeculectomy group Gender 5/10 (50%) men and 5/10 (50%) women in trabeculectomy + Ex‐PRESS mini shunt group; 4/10 (40%) men and 6/10 (60%) women in trabeculectomy group Inclusion criteria: IOP > 21 mmHg on maximum tolerated topical antiglaucoma medication (medication score 3 for all the eyes); had secondary angle‐closure NVG, as confirmed by gonioscopy. Exclusion criteria: not reported Equivalence of baseline characteristics: yes |
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Interventions |
Intervention 1: trabeculectomy + Ex‐PRESS mini shunt Intervention 2: trabeculectomy Length of follow‐up Planned: 1 year Actual: 1 year |
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Outcomes |
Primary outcomes, as defined: IOP, BCVA, central foveal thickness, intraoperative bleeding, postoperative complications, and secondary intervention: needling or diode‐cyclo photocoagulation Secondary outcomes, as defined: postoperative hypotony, surgical success rate Intervals at which outcomes assessed: 1 day; 1 week; 1, 3, and 6 months; 1 year |
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Notes |
Publication type: published article Funding sources: none Disclosures of interest: authors declared that they had no conflict of interest Trial registry: not reported Study period: October 2016 to November 2017 Subgroup analyses: none reported Publication language: English |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Study authors clearly reported that randomization was performed using computer‐generated numbers. Baseline characteristics in both groups were similar, suggesting effective randomization. |
Allocation concealment (selection bias) | Unclear risk | Study authors did not mention how the allocation concealment was performed. |
Masking of participants and personnel (performance bias) | Low risk | There was no description about masking study participants and personnel. However, as the IOP was an objective measurement for participants and personnel, it was unlikely that the unmasking of participants and personnel would affect the outcome. |
Masking of outcome assessment (detection bias) | High risk | Outcome assessors were not masked to the participant's group assignment. As the IOP measurement using Goldmann applanation could be subjective, there were some possibilities that the unmasking of outcome assessors would affect the outcome. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Study authors did not explicitly report the number of losses to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | No statistical analysis plan was available, so it was unclear if the reported approach to analyzing this outcome was prespecified or influenced by the results. |
Other bias | Low risk | Study authors had no financial or proprietary interest in this paper. |