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

Biedner 1998.

Study characteristics
Methods Study design: controlled clinical trial, paired‐eye design
Number randomized (total and per group): 7 children with 14 eyes; 7 right eyes underwent combined trabeculotomy‐trabeculectomy, and 7 left eyes underwent trabeculotomy alone
Number analyzed (total and per group): all children completed 6 months follow‐up; 6/7 children completed at least 1 year follow‐up
Losses to follow‐up: not reported
Length of follow‐up:
Planned: a minimum of 6 months
Actual: 40.29 ± 27.96 months
Sample size calculation (Y/N): N
Participants Country: Israel
Age: trabeculotomy‐trabeculectomy combined group: 3.43 ± 3.31 weeks; trabeculotomy‐alone group: 4.86 ± 3.89 weeks
Gender: not reported
Inclusion criteria: bilateral congenital glaucoma, younger than 3 months of age
Equivalence of baseline characteristics: each surgery was performed on the two eyes of the same participant. Ages at time of surgery differed by design (the right eye was always operated on first; the average time interval between the two procedures was 1.43 ± 1.62 weeks).
Interventions Intervention 1: trabeculotomy‐trabeculectomy combined procedure
Intervention 2: trabeculotomy alone
Outcomes Outcomes:
  • IOP before surgery and at the end of follow‐up

  • Complications during follow‐up


Intervals at which outcome assessed: IOP was measured at the last follow‐up of each participant
Issues with outcome assessment: none
Adverse effects: choroidal detachment, hyphema, shallow anterior chambers, corneal opacities, flat, diffuse filtering blebs
Notes Type of study: published
Funding: not reported
Declaration of interest: not reported
Study period: 1988 to 1995
Clinical trial registry: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk "The right eye underwent the trabeculotomy‐trabeculectomy combined procedure, and the left eye underwent trabeculotomy alone, regardless of the IOP recorded."
Allocation concealment (selection bias) High risk Allocation was not concealed.
Masking of participants and personnel (performance bias) Unclear risk The surgeon could not be masked. Not masking young children/infants is unlikely to introduce bias.
Masking of outcome assessment (detection bias) Unclear risk We do not know whether outcome assessors were masked.
Incomplete outcome data (attrition bias)
All outcomes Low risk Six out of seven children completed one‐year follow‐up.
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 and conflicts of interest were not reported.