Yildirim 2007.
Methods |
Study design: randomized controlled trial, parallel group Unit of analysis: eyes Number randomized: 35 participants (40 eyes), 20 eyes per group Number of arms: 2 Enrollment start year: not reported Length of follow‐up: 19 months Sample size calculations: “The power calculation of the study was found to be 0.45 for the satisfaction rates and was 0.08 for success rates, both of which were underpowered." Losses to follow‐up: not reported |
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Participants |
Country: Turkey Age (mean (SD)): 41.2 (11.5) in the MMC group, 39 (7.5) in the EX‐DCR alone group Females (n (%)): not reported Inclusion criteria: diagnosis of primary acquired nasolacrimal duct obstruction Exclusion criteria: previous DCR surgery Study group differences: no significant differences |
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Interventions |
Intervention: EX‐DCR with application of 1 mL of 0.02 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: Cem Yildirim Institution: Pamukkale University Email: yildirimc@hotmail.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 the random sequence was generated is not described. |
Allocation concealment (selection bias) | Unclear risk | How allocation was concealed is not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Whether participants and personnel were masked is not described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The same physician, who did not know whether the participant had received MMC application during surgery, documented subjective symptoms and objective findings. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Number randomized was analyzed. |
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'. |