Yalaz 1999.
Methods |
Study design: randomized controlled trial, parallel group Unit of analysis: participants Number randomized: 60 in total, 10 per group Number of arms: 5 Enrollment start year: 1995 Length of follow‐up: 12 months Sample size calculations: not reported Losses to follow‐up: none |
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Participants |
Country: Turkey Age (mean (SD)): 35 (13.81) in total Females (n (%)): 47 (78.3) in total Inclusion criteria: primary acquired idiopathic nasolacrimal duct obstruction Exclusion criteria: secondary nasolacrimal duct obstruction due to factors such as trauma, facial surgery, sinus disease, and revision DCR Study group differences: no difference |
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Interventions |
Intervention 1: EX‐DCR with application of 0.5 mg/mL MMC Intervention 2: EX‐DCR with application of 1 mg/mL MMC Intervention 3: EX‐DCR with application of 2.5 mg/mL 5‐FU Intervention 4: EX‐DCR with application of 5 mg/mL 5‐FU Comparison intervention: EX‐DCR alone |
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Outcomes |
Measured outcomes:
Adverse events: none |
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Identification |
Author name: Müslime Yalaz Institution: Çukurova University Medical Faculty Email: not reported |
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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 | "The patients were randomly divided into three groups". 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 | Unclear risk | Masking of outcome assessors was not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no missing outcome data at 12 months. |
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'. |