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. 2020 Aug 27;2020(8):CD008213. doi: 10.1002/14651858.CD008213.pub3

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
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"
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.
Outcomes Outcomes:
  • Surgical success defined as an IOP less than the presenting IOP for each eye and less than 16 mmHg under general anesthesia without any IOP‐lowering medications or hypotony‐related complications, lack of IOP‐related progression of the disease, or worsening of the ocular biometric characteristics beyond the usual for the age group studied

  • Mean IOP

  • Corneal diameter

  • C/D ratio

  • Axial length

  • Adverse events


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
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
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.