Elsheikha 2015.
Study characteristics | ||
Methods |
Study design: RCT (10 bilateral and 21 unilateral participants) Number randomized (total and per group): 41 eyes of 31 children; 21 eyes for viscotrabeculotomy and 20 for conventional trabeculotomy Number analyzed (total and per group): 14 eyes in viscotrabeculotomy and 12 eyes in conventional trabeculotomy Losses to follow‐up: 7 eyes in viscotrabeculotomy and 8 eyes in conventional trabeculotomy Length of follow‐up: Planned: 6 months Actual: 6 months Sample size calculation (Y/N): N |
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Participants |
Country: Egypt Age: viscotrabeculotomy: 6.8 ± 6.5 months; conventional trabeculotomy: 6.9 ± 5.65 months Gender: viscotrabeculotomy: 14/21 boys (66.6%) and 7/21 (33.4%) girls; conventional trabeculotomy: 8/20 (40%) boys and 12/20 (60%) girls Inclusion criteria: primary congenital glaucoma in the first two years of life or primary congenital glaucoma with a previous single failure of goniotomy surgery Exclusion criteria: secondary glaucoma, patients previously operated for trabeculotomy or combined trabeculotomy–trabeculectomy, and those with anterior segment dysgenesis syndrome Equivalence of baseline characteristics: comparable |
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Interventions |
Intervention 1: viscotrabeculotomy Intervention 2: conventional trabeculotomy |
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Outcomes |
Outcomes:
Intervals at which outcome assessed: week 1, 2, 3, month 1, 2, 3, 4, 5, and 6 Issues with outcome assessment: for some participants, both eyes of the same child were included, but study did not consider intraperson correlation Adverse effects: intraoperative complication reported |
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Notes |
Type of study: published Funding: "This research received no specific grant from any funding agency in the public, commercial or not‐for‐profit sectors." Declaration of interest: "The authors report no competing interest." Study period: not specified Clinical trial registry: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of random sequence generation was not reported: "Patients were randomly allocated to either one of two groups: group A undergoing viscotrabeculotomy and group B (control group) undergoing conventional trabeculotomy." |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not reported. |
Masking of participants and personnel (performance bias) | Unclear risk | Masking of participants and investigators to treatment was not described. |
Masking of outcome assessment (detection bias) | Unclear risk | Masking of outcome assessor was not described. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Seven (33.3%) eyes in viscotrabeculotomy group and eight (40%) eyes in conventional trabeculotomy group were not included in the analysis. |
Selective reporting (reporting bias) | Unclear risk | Neither protocol nor clinical trial registry was found. |
Other bias | Low risk | None identified. |