Kim 2002.
Methods |
Study design: randomized controlled trial, parallel group Unit of analysis: eyes Number randomized: 100 participants in total, 50 participants (59 eyes) in Group A, 50 participants (62 eyes) in Group B Number of arms: 2 Enrollment start year: 1993 Length of follow‐up: average of 10.2 months (range 6 to 24 months) Sample size calculations: not reported Losses to follow‐up: none |
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Participants |
Country: South Korea Age (mean (SD)): 52 (NR) in total Females (n (%)): 89 (89) in total, 45 (90) in Group A, 44 (88) in Group B Inclusion criteria: diagnosis of nasolacrimal duct obstruction Exclusion criteria: not reported Study group differences: not reported |
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Interventions |
Intervention: Group A: endonasal DCR with 0.2 mg/mL MMC application during surgery Comparison intervention: Group B: endonasal DCR |
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Outcomes |
Measured outcomes:
Adverse events: granulation tissue, membranous obstruction, protrusion of silicone tube, prolapse of orbital fat, canaliculitis, nasal mucosal erosion |
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Identification |
Author name: Kim Yt Institution: Yeungnam University Hospital Email: chungwha@med.yu.ac.kr |
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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) | Low risk | Used 100 color cards (50 blue, 50 yellow) and randomly chose from a bag to assign participants. |
Allocation concealment (selection bias) | Low risk | Color cards were used to conceal treatment allocation. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Masking of participants and study 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 data. |
Selective reporting (reporting bias) | Unclear risk | No trial or protocol registration available for comparison to ascertain selective outcome reporting. |
Other bias | Low risk | Study appears to be free of other sources of bias. |