Bayoumi 2012.
| Study characteristics | ||
| Methods |
Study design: RCT, parallel‐group design with one study eye per child Number randomized (total and per group): 20 eyes of 20 children; 10 for combined trabeculectomy‐trabeculotomy with MMC alone and 10 for combined trabeculectomy‐trabeculotomy with MMC with deep sclerectomy Number analyzed (total and per group): all children completed at least 6 months follow‐up; children analyzed at 1 year were not reported Losses to follow‐up: all children completed at least 6 months follow‐up Length of follow‐up: Planned: not reported Actual: 18.5 ± 9.2 (range 8 to 35) months for the combined trabeculectomy‐trabeculotomy with MMC group; 14.6 ± 4.3 (range 6 to 20) for the deep sclerectomy group Sample size calculation (Y/N): N |
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| Participants |
Country: Egypt Age: combined trabeculectomy‐trabeculotomy with MMC group: 4.7 ± 2.0 months; deep sclerectomy group: 7.0 ± 3.8 months Gender: combined trabeculectomy‐trabeculotomy with MMC group: 6/10 (60%) boys and 4/10 (40%) girls; deep sclerectomy group: 8/10 (80%) boys and 2/10 (20%) girls Inclusion criteria: diagnosis of primary congenital glaucoma Equivalence of baseline characteristics: "There were no statistically significant differences between the two groups of participants as regards the preoperative variables, including age, IOP, corneal diameter, cup/disc ratio, and axial length" |
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| Interventions |
Intervention 1: combined trabeculectomy‐trabeculotomy with MMC Intervention 2: combined trabeculectomy‐trabeculotomy with MMC plus deep sclerectomy |
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| Outcomes |
Outcomes:
Intervals at which outcome assessed: 1, 2, 3, 6, 9, and 12 months Issues with outcome assessment: none Adverse effects: yes |
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| Notes |
Type of study: published Funding: not reported Declaration of interest: "The author declares no conflict of interest" Study period: not reported Clinical trial registry: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | “A CTTM (combined trabeculectomy‐trabeculotomy with MMC) was conducted in all the patients. Intraoperatively, eyes were randomized for the procedure of CTTM alone or with the addition of a deep sclerectomy. Randomization was carried out by a flip coin choice by an attending assistant nurse. Randomization was not carried out preoperatively in order to avoid surgeon bias in changing the thickness of the scleral flap created during the initial part of the surgery, tending to make it thinner in cases in which deep sclerectomy was planned and thicker (deeper dissection) in cases without deep sclerectomy.” |
| Allocation concealment (selection bias) | Low risk | Since the randomization was done intraoperatively, and was determined by flip of coin, the next allocation was not known. |
| Masking of participants and personnel (performance bias) | Low risk | The surgeon could not be masked. However, the study carried out randomization intraoperatively in order to avoid surgeon bias in changing the thickness of the scleral flap created during the initial part of the surgery, e.g. making it thinner in cases in which deep sclerectomy was planned and thicker (deeper dissection) in cases without deep sclerectomy. Not masking young children/infants is unlikely to introduce bias. |
| Masking of outcome assessment (detection bias) | Unclear risk | The measurements of IOP, optic nerve cupping, corneal diameter, and axial length were all done by an ophthalmologist (rather than the surgeon who performed the procedure). We are not aware if this person was masked. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | All children completed at least six months follow‐up; the number of children analyzed at one year was not reported. |
| Selective reporting (reporting bias) | Unclear risk | The protocol was not available. Outcomes prespecified in the Methods section matched the outcomes reported in the Results section. |
| Other bias | Unclear risk | Source of funding was not reported. |