Skip to main content
. 2020 Aug 27;2020(8):CD008213. doi: 10.1002/14651858.CD008213.pub3

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
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
Interventions Intervention 1: viscotrabeculotomy
Intervention 2: conventional trabeculotomy
Outcomes Outcomes:
  • Mean IOP

  • Complete success defined as IOP of 18 mmHg or less, under chloral hydrate sedation or general anesthesia, without the need for medication or reoperation, with no progression of disc cupping or corneal diameter, and no devastating visual complications

  • Corneal diameter

  • C/D ratio


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
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
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.