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 |
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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). |
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Interventions |
Intervention 1: trabeculotomy‐trabeculectomy combined procedure Intervention 2: trabeculotomy alone |
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Outcomes |
Outcomes:
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 |
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Notes |
Type of study: published Funding: not reported Declaration of interest: not reported Study period: 1988 to 1995 Clinical trial registry: not reported |
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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. |