Gonzalvo 2000.
Methods |
Study design: randomized controlled trial, parallel group Unit of analysis: participants Number randomized: 30 in total, 15 per group Number of arms: 2 Enrollment start year: 1996 Length of follow‐up: 6 months Sample size calculations: not reported Losses to follow‐up: not reported |
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Participants |
Country: Spain Age (mean (SD)): 48.11 (11.77) in total, 52.33 (4.82) in the MMC group, 43.5 (15.2) in the EX‐DCR alone group Females (n (%)): 11 (64) in total, 6 (75) in the MMC group, 5 (55) in the EX‐DCR alone group Inclusion criteria: patients with nasolacrimal duct obstruction after previous canaliculation Exclusion criteria: none Study group differences: not reported |
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Interventions |
Intervention: EX‐DCR with MMC (0.2 mg/mL) application during surgery Comparison intervention: EX‐DCR alone |
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Outcomes |
Measured outcomes:
Adverse events: development of herpes zoster of cranial nerve V |
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Identification |
Author name: Francisco Jose Gonzalvo Ibanez Institution: Hospital Universitario Miguel Servet Email: not reported |
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Notes |
Funding source: not reported Declarations of interest: none 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 random component in the sequence generation process was not described. |
Allocation concealment (selection bias) | Unclear risk | The method of concealment was not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Although participants and outcome assessors did not have knowledge of the groups to which participants had been assigned, masking of study personnel was not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The patient and the outcome assessor did not have knowledge of the group designated to each patient" |
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'. |