Read 1974.
Methods | Study design: Quasi‐randomized controlled series. Exclusions after allocation: None. Losses to follow‐up: None. Intention‐to‐treat: All participants were analyzed in the groups to which they had been assigned. Sample size calculations: Not reported. |
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Participants | Country: USA. Dates: February 1970 to July 1972. Number allocated: 137 consecutive patients. Age: Mean 15.9 years. Sex: 108 men and 29 women; 79% male. Race: 101 (74%) African‐American. Sickle cell disease: Not reported. Participants were similar with respect to baseline characteristics. Inclusion criteria: Traumatic hyphema. Exclusion criteria:
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Interventions | Medical treatment #1 (n = 66): Bed rest with elevation of head to 30°, bilateral ocular patches and shield over injured eye, and sedation. Medical treatment #2 (n = 71): Moderate ambulatory activity in the hospital, patching and shielding of the traumatized eye only, and no sedation. Eyedrops were not administered in either medical treatment regimen. On day 5, participants with remaining major primary or secondary hyphemas (n = 16) were alternately assigned to continue with medical treatment or to receive surgical intervention (ab externo corneal section with clot expression). |
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Outcomes | Primary and secondary outcomes not specified. Measured outcomes:
Follow‐up: 1 week, 1, 3, and 6 months (range 3 months to 2.5 years; mean 16.5 months). |
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Notes | Funded by a grant from Research to Prevent Blindness, Inc | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Allocation was not randomized; alternately assigned patients to treatment groups at time of admission. Imbalance in number assigned to each group (66 vs 71) suggests alternation was not systematic. |
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 under study. |
Blinding (performance bias and detection bias) Personnel and outcome assessors | High risk | All participants were treated by the primary investigator in order to standardize therapy and to record results as accurately as possible. |
Incomplete outcome data (attrition bias) Primary outcome | Low risk | All participants were analyzed in the group to which they had been assigned. |
Incomplete outcome data (attrition bias) Secondary outcomes | Low risk | All participants were analyzed in the group to which they had been assigned. |
Selective reporting (reporting bias) | Low risk | Reported results for all outcomes |
Other bias | High risk | A subset of participants with major hyphema on day 5 were alternately allocated to either continue with medical treatment as originally assigned or to undergo surgical intervention. The participants that had surgery were thus censored on day 5 from their medical treatment outcomes. |