Rakusin 1972.
Methods | Study design: Quasi‐randomized controlled series. Exclusions after allocation: 59 patients in the series with large hyphemas underwent surgery and were not included in the analysis. Losses to follow‐up: 20. Intention‐to‐treat: Not all participants were accounted for in the final analyses, thus intention‐to‐treat analysis was not performed. Sample size calculations: Not reported. |
|
Participants | Country: South Africa. Dates: 1966‐69. Number allocated: 390 consecutive patients. Age: Not reported. Sex: Not reported. Sickle cell disease: Not reported. Race: 90% African origin, 10% Asiatic origin. Inclusion criteria: Traumatic hyphema. Exclusion criteria: Surgical treatment indicated. |
|
Interventions | Series of comparisons based on 6 variable factors:
Treatment and control groups followed the same regimen, except even‐numbered participants received the variable factor, and odd‐numbered participants did not. Excluding the variable factor for each series, all participants received bed rest, single pad over the injured eye, and topical chloramphenicol. |
|
Outcomes | Primary outcomes:
Follow‐up: Range 1 to 2 weeks to 3 years. |
|
Notes | Funded by the University of Witwatersrand, the South African Medical Research Council, Leo Laboratories, Mer‐National, and Warner Pharmaceutical Co. In the third comparison group, antibiotics versus corticosteroids, 3 participants were assigned to receive neither treatment, but this group was discontinued after all 3 participants developed a mucous conjunctival discharge. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Method of allocation unclear, not all patients in the series were allocated to the 6 comparisons under study; 59 patients were selected for surgery. Also, even and odd patient number allocation is not applicable to comparison with 3 treatment groups. |
Allocation concealment (selection bias) | High risk | Method of allocation concealment not reported, not randomized. |
Blinding (performance bias and detection bias) Participants | High risk | Masking of participants was not possible for some variables (i.e. bed rest and eye patching). Use of placebo for other variables was not mentioned. |
Blinding (performance bias and detection bias) Personnel and outcome assessors | Unclear risk | Masking was not reported. |
Incomplete outcome data (attrition bias) Primary outcome | Unclear risk | 79 participants were not included in the analyses, and the intention‐to‐treat principle was not followed. |
Incomplete outcome data (attrition bias) Secondary outcomes | Unclear risk | 79 participants were not included in the analyses, and the intention‐to‐treat principle was not followed. |
Selective reporting (reporting bias) | Low risk | Reported results for primary and secondary outcomes |
Other bias | Unclear risk | The primary interventions of interest for this study were not clear. Although the majority of the patients in the series were assigned to 1 of 6 conservative‐treatment comparison groups, 59 recruited patients were selected for surgery. |