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. 2023 Mar 13;2023(3):CD010472. doi: 10.1002/14651858.CD010472.pub3

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.
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
Interventions Intervention 1: trabeculectomy + Ex‐PRESS mini shunt
Intervention 2: trabeculectomy
Length of follow‐up
Planned: 1 year
Actual: 1 year
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
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
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.