Roozitalab 2004.
Methods |
Study design: randomized controlled trial, parallel group Unit of analysis: participants Number randomized: 130 in total, 65 per group Number of arms: 2 Enrollment start year: 2001 Length of follow‐up: 6 months Sample size calculations: not reported Losses to follow‐up: none |
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Participants |
Country: Iran Age (mean (SD)): 40 (15) in the MMC group, 42 (16) in the EX‐DCR group Females (n (%)): 89 (68.5) in total, 49 (75) in the MMC group, 40 (62) in the EX‐DCR group Inclusion criteria: diagnosis of nasolacrimal duct obstruction (congenital and acquired) Exclusion criteria: not reported Study group differences: no significant difference in age |
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Interventions |
Intervention: EX‐DCR with application of 0.2 mg/mL MMC Comparison intervention: EX‐DCR alone |
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Outcomes |
Measured outcomes:
Adverse events: none |
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Identification |
Author name: MR Namazi Institution: Shiraz University of Medical Sciences Email: Namazi_mr@yahoo.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 | Method of random sequence generation was not reported. |
Allocation concealment (selection bias) | Unclear risk | Method of treatment allocation concealment was not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Masking of participants and personnel was not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All the examinations were done by the second author, who was masked to the procedures. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no missing outcome data. |
Selective reporting (reporting bias) | Unclear risk | No trial or protocol registration available for comparison to ascertain selective outcome reporting. |
Other bias | Unclear risk | There was insufficient information to permit a judgement of 'low risk' or 'high risk'. |