Table 3.
Risk of bias in included studies
| Bias | Judgement | Justification |
| Donnenfeld, 2011 | ||
| Random sequence generation (selection bias) | Low risk | ‘patients were assigned randomly to receive either difluprednate or prednisolone for treatment of the first eye; the second eye was assigned the alternative medication’ |
| Allocation concealment (selection bias) | Low risk | ‘Allocation of the medication was concealed from the investigators based on a random number list generated using randomizer.org’ |
| Blinding of participants and personnel (performance bias) | Low risk | ‘Both investigators and patients were masked to the treatment condition. Study medication (obtained from commercial sources) was relabeled in a manner so as to obscure the bottle shape and contents’ |
| Blinding of outcome assessment | Unclear risk | Not reported |
| Incomplete outcome data | Low risk | All relevant outcomes were reported in detail |
| Selective reporting (reporting bias) | Low risk | All study patients were included in the analysis |
| Other bias | High risk | ‘Publication of this article was supported with an unrestricted grant from Sirion Therapeutics, Tampa, Florida’. Donnenfeld, Holland and Solomon have received consulting fees, honoraria and research support from Alcon Laboratories, Allergan, Bausch and Lomb, and Sirion |
| Manna, 2016 | ||
| Random sequence generation (selection bias) | High risk | ‘odd number patients were included in group -A (Difluprednate) and the even number patients were included in group -B (Prednisolone)’ |
| Allocation concealment (selection bias) | High risk | ‘odd number patients were included in group -A (Difluprednate) and the even number patients were included in group -B (Prednisolone)’ |
| Blinding of participants and personnel (performance bias) | High risk | ‘It is a single-blinded study’ |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) | Low risk | All enrolled patients were included in the analysis |
| Selective reporting (reporting bias) | Low risk | All relevant outcomes were reported |
| Other bias | Low risk | Not detected |
| Wilson, 2016 | ||
| Random sequence generation (selection bias) | Low risk | ‘Patients were randomly assigned to treatment groups in accordance to a planned ratio of 1:1. Randomisation numbers were generated using computer software (PROC PLAN, SAS Institute, Cary, North Carolina, USA)” |
| Allocation concealment (selection bias) | Unclear risk | No specified method reported |
| Blinding of participants and personnel (performance bias) | Low risk | ‘Patients, caregivers, and investigators were masked to the medication being instilled. Because prednisolone acetate 1% is a suspension that needs to be shaken before instillation, parents or legal guardians of patients were instructed to shake the assigned medication bottle before instillation to preserve masking’ |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) | Low risk | All enrolled patients were included |
| Selective reporting (reporting bias) | Low risk | All specified outcomes are reported |
| Other bias | High risk | ‘The study was sponsored and supported, in part, by a grant from Alcon Laboratories, Inc. (Fort Worth, TX, USA). Alcon Laboratories, Inc. participated in the design and conduct of the study, data collection, data management, data analysis, interpretation of the data, preparation, review, and approval of the manuscript’ |
| Garg, 2016 | ||
| Random sequence generation (selection bias) | Low risk | ‘They were randomly divided into two groups’ |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not reported |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) | Low risk | All enrolled patients were followed for the study duration |
| Selective reporting (reporting bias) | Low risk | Main outcomes were reported |
| Other bias | Low risk | No other bias could be detected |
| Gundakalle; ‘A 1 year randomised controlled trial to compare the effectiveness and safety of difluprednate ophthalmic emulsion 0.05% with topical prednisolone acetate 0.1% ophthalmic suspension in the control of postoperative inflammation following cataract surgery’ | ||
| Random sequence generation (selection bias) | Unclear risk | Randomisation method wasn't specified |
| Allocation concealment (selection bias) | Unclear risk | Concealment method wasn’t reported |
| Blinding of participants and personnel (performance bias) | Unclear risk | Authors didn’t report if blinding was applied or not |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) | Low risk | All study personnel were followed, and the master data sheet was included in the online supplementary appendix |
| Selective reporting (reporting bias) | Low risk | All relevant outcomes were reported and analysed |
| Other bias | Low risk | No other form of bias could be detected |
| Devi, 2014 | ||
| Random sequence generation (selection bias) | Unclear risk | Authors reported that ‘100 patients were randomised 1:1 into two groups’, however, randomisation method wasn't specified |
| Allocation concealment (selection bias) | Unclear risk | Concealment method wasn’t reported |
| Blinding of participants and personnel (performance bias) | High risk | ‘open-labelled study’ |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) | Unclear risk | The authors didn’t report the proportion of patients assessed at each follow-up visit |
| Selective reporting (reporting bias) | Low risk | All relevant outcomes were reported |
| Other bias | Low risk | No other form of bias could be detected |