Ghosh 2006.
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: 2003 Length of follow‐up: 12 months Sample size calculations: not reported Losses to follow‐up: not reported |
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Participants |
Country: India Age (mean (SD)): 32.5 (NR) in total Females (n (%)): 20 (67) in total Inclusion criteria: recurrent epiphora for more than 2 to 4 months not responding to medical therapy Exclusion criteria: acute dacryocystitis, recurrent abscesses, tumors of the lacrimal apparatus Study group differences: not reported |
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Interventions |
Intervention: EX‐DCR with application of 0.2 mg/mL MMC Comparison intervention: EX‐DCR alone |
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Outcomes |
Measured outcomes:
Adverse events: stenosis of the stoma, synechia |
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Identification |
Author name: Soumitra Ghosh Institution: Ramakrishna Mission Seva Pratishthan, Vivekananda Institute of Medical Sciences 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 | No mention of how sequence generation was performed. |
Allocation concealment (selection bias) | Unclear risk | No description of allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No description of masking of participants or personnel. |
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 | All participants enrolled in the study were accounted for in the analysis. |
Selective reporting (reporting bias) | High risk | Syringing performed, but no reporting of anatomic patency as a result. In addition, stoma and complaints of epiphora bound together as a combined outcome result. |
Other bias | Unclear risk | There was insufficient information to permit a judgement of 'low risk' or 'high risk'. |