Kao 1997.
Methods |
Study design: randomized controlled trial, parallel group Unit of analysis: eyes Number randomized: 15 eyes (of 14 participants), 7 eyes in the MMC group, 8 eyes in EX‐DCR alone group Number of arms: 2 Enrollment start year: 1994 Length of follow‐up: 6 months Sample size calculations: not reported Losses to follow‐up: none |
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Participants |
Country: Taiwan Age (mean (SD)): 55 (9.5) in the MMC group, 52 (14.7) in the EX‐DCR alone group Females (n (%)): not reported Inclusion criteria: patients with primary acquired nasolacrimal duct obstruction Exclusion criteria: not reported Study group differences: not reported |
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Interventions |
Intervention: EX‐DCR with 0.2 mg/mL MMC application during surgery Comparison intervention: EX‐DCR alone |
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Outcomes |
Measured outcomes:
Adverse events: septo‐osteotomy adhesion |
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Identification |
Author name: Shine CS Kao Institution: National Taiwan University Hospital 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 | Method of random sequence generation was not reported. |
Allocation concealment (selection bias) | Unclear risk | 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 calculations were done by one of our staff members who did not know whether he was looking at a photograph of a mitomycin C group or a control group patient." Masking of other outcome assessors was not reported. |
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'. |