Edwards 1973.
Methods | Study design: Quasi‐randomized controlled series. Exclusions after allocation: Individuals over 20 years old were excluded from the study because of the small number enrolled. Losses to follow‐up: None. Intention‐to‐treat: Participants aged 20 years and younger were analyzed in the group to which they had been assigned. Sample size calculations: Not reported. |
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Participants | Country: USA. Dates: 1969 to 1971. Number allocated: 64 consecutive patients alternately assigned to treatment group. Age: Mean 10 years (up to 20 years). Sex: 61 (95%) men and 3 (5%) women. Race: Not reported. Sickle cell disease: Not reported. Participants appeared to be balanced with respect to baseline characteristics. Inclusion criteria: Traumatic hyphema. Exclusion criteria: Individuals over 20 years of age. |
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Interventions | Treatment: Monocular patching (n = 35) Control: Binocular patching (n = 29) Treatment for both groups included:
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Outcomes | Primary and secondary outcomes not specified. Measured outcomes:
Follow‐up: Days 1 to 7. |
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Notes | Funded by Research to Prevent Blindness Inc, Public Health Service Training Grant, and the National Institutes of Health | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Allocation was not randomized: an independent study director assigned participants to treatment groups on an alternate basis by turning a card. Occasionally the card was not turned each time, which led to an uneven number of participants in each group. |
Allocation concealment (selection bias) | High risk | Allocation was assigned on an alternate basis. |
Blinding (performance bias and detection bias) Participants | High risk | Masking of participants was not possible given the interventions being studied. |
Blinding (performance bias and detection bias) Personnel and outcome assessors | Unclear risk | The authors reported that the study was double‐masked, although this statement was not clear. The study investigators seldom participated in participant care to allow other examiners with less experience in monocular patching to collect data in hopes of minimizing observation bias. |
Incomplete outcome data (attrition bias) Primary outcome | Unclear risk | Individuals over 20 years of age were excluded after allocation to treatment group. |
Incomplete outcome data (attrition bias) Secondary outcomes | Unclear risk | Individuals over 20 years of age were excluded after allocation to treatment group. |
Selective reporting (reporting bias) | Low risk | Reported results for all outcomes |
Other bias | Low risk | No other sources of potential bias were identified. |