Park 2000.
| Methods |
Study design: randomized controlled trial, parallel group Unit of analysis: eyes Number randomized: 66 participants (75 eyes) in total, 37 in the MMC group, 38 in the EN‐DCR alone group Number of arms: 2 Enrollment start year: 1997 Length of follow‐up: mean of 6.8 months in the MMC group (range 4 to 16 months), mean of 7.2 months in the EN‐DCR alone group (range 4 to 19 months) Sample size calculations: not reported Losses to follow‐up: none |
|
| Participants |
Country: South Korea Age (mean (SD)): 54 (NR) in the MMC group, 52 (NR) in the EN‐DCR alone group Females (n (%)): 66 (88) in total, 35 (95) in the MMC group, 31 (82) in the EN‐DCR alone group Inclusion criteria: diagnosis of nasolacrimal duct obstruction Exclusion criteria: not reported Study group differences: no significant differences between groups |
|
| Interventions |
Intervention: EN‐DCR with application of 0.2 mg/mL MMC Comparison intervention: EN‐DCR alone |
|
| Outcomes |
Measured outcomes:
Adverse events: orbital fat herniation, nasal septal wall injury, rebleeding, tube protrusion |
|
| Identification |
Author name: Mi Seon Kwak Institution: Taegu Fatima Hospital Email: not reported |
|
| Notes |
Funding source: not reported Declarations of interest: not reported Trial registration number: not reported |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of random sequence generation not reported. |
| Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not reported. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | 1 surgeon performed all surgeries; masking of participants not reported. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Masking of outcome assessors not reported. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition or missing 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'. |