Alañón 2006.
| Methods |
Study design: randomized controlled trial, parallel group Unit of analysis: participants Number randomized: 200 total, 150 in the MMC group, 50 in the endonasal and endocanalicular DCR by diode laser (TLA‐ELA DCR) group Number of arms: 2 Enrollment start year: 2002 Length of follow‐up: 6 months Sample size calculations: not reported Losses to follow‐up: not reported |
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| Participants |
Country: Spain Age (mean (SD)): 59.51 (NR) in the TLA‐ELA DCR alone group, 62.33 (NR) in the MMC group Females (n (%)): 162 (88.5%) in total Inclusion criteria: not reported Exclusion criteria: not reported Study group differences: no statistically significant differences in age, sex, laterality, or follow‐up between groups |
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| Interventions |
Intervention: TLA‐ELA DCR with application of 0.4 mg/mL MMC Comparison intervention: TLA‐ELA DCR alone |
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| Outcomes |
Measured outcomes:
Adverse events: excessive scarring of the nasal mucosa in the form of scabs, granulomas and synechia |
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| Identification |
Author name: Miguel Ángel Alañón Fernández Institution: Instituto Internacional de Vías Nasolagrimales Email: miguelaaf@msn.com |
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| Notes |
Funding source: not reported Declarations of interest: not reported Trial registration number: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | How random sequence was generated is not described. |
| Allocation concealment (selection bias) | Unclear risk | No details are provided regarding allocation concealment. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Masking of participants or study personnel is not reported. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Masking of outcome assessors is not reported. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Missing data were not reported, unclear whether participants were analyzed in the group to which they were randomized. |
| Selective reporting (reporting bias) | Unclear risk | No mention of functional or anatomic success, and no prior registered trial to be used as comparison. |
| Other bias | Unclear risk | There was insufficient information to permit a judgement of 'low risk' or 'high risk'. |