| Study |
Bias |
| Randomisation process |
Deviations from intended interventions |
Missing outcome data |
Measurement of the outcome |
Selection of the reported results |
Overall |
| Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
| Subgroup 1.2.1 At one week, VAS 0 to 5 (higher is better) |
| Hall 2009 |
Some concerns |
The authors did not describe details about the process of allocation concealment was performed if any at all. |
Some concerns |
Trial registration listed the trial as 'single‐blind (participants)'. The analyses were per protocol and excluded those with incomplete data. The reasons for missing data were not described. No information available to determine whether there were potential deviations from the intervention. |
Low risk of bias |
Data of this outcome were available for nearly all participants (240/248 = 97%). |
Some concerns |
Single questionnaire of VAS of 0 to 5 scale was used for assessing overall comfort. Although not uncommon, the instrutment was not previously validated. Outcome assessment was based on participants' self‐reporting and the participants were masked (single‐blinded). |
High risk of bias |
There was no prespecified analysis plan provided. There were differences in the reported mean difference and its associated 97.5% confidence intervals between the conference abstract and the trial registry record online. We collected data from the trial registry website for the current meta‐analysis. |
High risk of bias |
The trial was judged as high risk in selective outcome reporting. Some concerns also existed in the randomization process, risks of potential deviations from the intervention, and biased outcome measurement. |
| Subgroup 1.2.2 At three months, VAS 0 to 100 (higher is better) |
| Diec 2012 |
Some concerns |
"Randomisation list will be generated from simple randomisation using randomisation computer software." The method of allocation concealment is not detailed. The authors reported no statistical differences in baseline characteristics. Neophytes were split equally across arms. It is not clear how they accounted for this in randomization. |
Low risk of bias |
The study was an open‐label, prospective clinical trial that included experienced and neophyte myopic participants randomized to one of three lens types, worn bilaterally. There do not appear to be deviations. Linear mixed models included multiple measurements. Appears to be an intention‐to‐treat analysis. |
Low risk of bias |
7/140 participants are missing. There are 6 discontinuations in Narafilcon A and 1 in Senofilcon A. The timepoint and impact on outcome are not described. |
High risk of bias |
A numeric scale of 0 to 100 was not inappropriate. The outcome was measured in the same manner across groups. The participant was not masked (open‐label) and it was possible that observers were influenced by the knowledge of the lens type. |
Some concerns |
There was no statistical analysis plan available for evaluation. Data of this outcome were analyzed based on repeated measure analysis (averaged over all follow‐up visits) to take advantage of the multiple measurements. It was unclear whether this analytic approach was defined apriori or based on resutls of signigicance testing. |
High risk of bias |
The trial was judged to be at high risk in biased outcome measurement as well as some concerns in allocation concealment, the randomization process, and selective outcome reporting. |
