Khalil 2016.

Study characteristics
Methods	Study design: RCT, parallel‐group design with one study eye per child Number randomized (total and per group): 28 eyes of 28 children; 14 in each group Number analyzed (total and per group): 28 eyes of 28 children; 14 in each group Losses to follow‐up: not reported Length of follow‐up: Planned: 3 years Actual: 3 years Sample size calculation (Y/N): Y (details of sample size and power not reported)
Participants	Country: Egypt Age: trabeculotomy: 6.52 ± 3.89 months; combined trabeculotomy–trabeculectomy with mitomycin C: 5.62 ± 3.96 months Gender: trabeculotomy: 11/14 (78.6%) boys and 3/14 (21.4%) girls; combined trabeculotomy–trabeculectomy with mitomycin C: 11/14 (78.6%) boys and 3/14 (21.4%) girls Inclusion criteria: primary congenital glaucoma in the first two years of life with no previous ocular surgeries Exclusion criteria: any childhood glaucoma other than primary congenital glaucoma Equivalence of baseline characteristics: "There was no significant difference between both groups regarding age and gender"
Interventions	Intervention 1: trabeculotomy Standard trabeculotomy Intervention 2: combined trabeculotomy–trabeculectomy with mitomycin C Trabeculotomy‐trabeculectomy with mitomycin C (0.2 mg/mL)‐soaked pieces of microsponge 494 mm2 were applied under the scleral flap and the conjunctiva for four minutes.
Outcomes	Outcomes: Mean IOP Surgical success defined as resolution of corneal edema, reversal of disc cupping, and an IOP measurement of 18 mmHg or less on no IOP‐lowering medical treatment C/D ratio Adverse events Intervals at which outcome assessed: month 1 and 6, year 1, 2, and 3. Issues with outcome assessment: none Adverse effects: yes
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: not reported Study period: between January 2012 and September 2012 Clinical trial registry: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Infants with proved congenital glaucoma were randomly (using random computer‐generated numbers) allocated to either group A (trabeculotomy) or group B (combined trabeculotomy–trabeculectomy with mitomycin C) under general anaesthesia."
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment was not described.
Masking of participants and personnel (performance bias)	Unclear risk	Masking of participants and study personnel was not reported.
Masking of outcome assessment (detection bias)	Unclear risk	Masking of outcome assessors was not reported.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Numbers of participants who were excluded or lost to follow‐up were not reported.
Selective reporting (reporting bias)	Unclear risk	Neither protocol nor clinical registry was available.
Other bias	Unclear risk	Conflicts of interest were not reported.