Bayoumi 2017.
Study characteristics | ||
Methods |
Study design: RCT, parallel‐group design with one study eye per child Number randomized (total and per group): 39 eyes of 39 children; 20 for regular suture and 19 for releaseable suture Number analyzed (total and per group): 39 eyes of 39 children; 20 for regular suture and 19 for releaseable suture Losses to follow‐up: none Length of follow‐up: 24 months Study period: Planned: 24 months Actual: 24 months Sample size calculation (Y/N): N |
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Participants |
Country: Egypt Age: regular suture group: 6.7 ± 5.8 months; releaseable suture group: 5.3 ± 2.8 months Gender: regular suture group: 11/20 (55%) boys and 9/20 (45%) girls; releaseable suture group: 9/19 (47.4%) boys and 10/19 (52.6%) girls Included criteria: primary congenital glaucoma on no medications preoperatively Excluded criteria: secondary glaucoma and/or associated ocular or systemic anomaly prior medical treatment Equivalence of baseline characteristics: "There were no statistically significant differences between groups with regard to age, gender, laterality or preoperative clinical characteristics" |
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Interventions |
Intervention 1: combined trabeculotomy‐trabeculectomy with MMC with regular suture Scleral flap closure by one apical suture and suture on either side of the scleral flap Intervention 2: combined trabeculotomy‐trabeculectomy with MMC with releaseable suture Scleral flap closure by releaseable suture. Releaseable sutures, made of 10‐0 nylon, consisted of an initial corneal tunnel, an astride limbus short tunnel, a scleral flap bite, and a scleral bed edge bite. Releaseable sutures were tied with four throw knots without locking, and tension was adjusted to the same endpoint as the regular sutures. |
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Outcomes |
Outcomes:
Intervals at which outcome assessed: days 1,4, and 7, and weeks 2 and 3, followed by postoperative examinations under anesthesia conducted at 1, 3, 6, 9, 12, and 24 months Issues with outcome assessment: none Adverse effects: yes |
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Notes |
Type of study: published Funding: "The author has no financial or proprietary interest in the materials presented herein." Declaration of interest: "The author has no financial or proprietary interest in the materials presented herein." 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 | "During closure of the scleral flap, eyes were randomized (by a coin flip by an attending assistant nurse) to closure by either regular or releasable sutures." |
Allocation concealment (selection bias) | Low risk | Participants could not foresee the assignment: "During closure of the scleral flap, eyes were randomized (by a coin flip by an attending assistant nurse) to closure by either regular or releasable sutures" |
Masking of participants and personnel (performance bias) | Unclear risk | Masking of participant and surgeon was not described. |
Masking of outcome assessment (detection bias) | Unclear risk | Masking of outcome assessors was not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition or exclusions reported in Figure 2. All eyes followed up: "All patients completed 24 months of follow‐up." |
Selective reporting (reporting bias) | Unclear risk | Neither protocol nor clinical trial registry was available. |
Other bias | Low risk | No interest was declared, although source of funding was not mentioned. |