Eshraghy 2012.
Methods |
Study design: randomized controlled trial, parallel group Unit of analysis: participants Number randomized: 88 in total, 42 in Group A, 46 in Group B Number of arms: 2 Enrollment start year: 2008 Length of follow‐up: average of 10 months (range 6 to 15 months) Sample size calculations: not reported Losses to follow‐up: none |
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Participants |
Country: Iran Age (mean (SD)): 50.7 (8.9) in Group A, 49.5 (9.9) in Group B Females (n (%)): 41 (46.6) in total, 19 (45.2) in Group A, 22 (47.9) in Group B Inclusion criteria: history of dacryocystitis in past 3 months, inappropriate lacrimal sac or nasal mucosal sac Exclusion criteria: tearing secondary to identifiable and treatable causes (e.g. dry eye, trichiasis, entropion or ectropion, common canaliculus obstruction, fracture of the facial bones, tumor of the eyelid or the lacrimal sac), previously failed DCR surgery Study group differences: group differences in age were not statistically significant |
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Interventions |
Intervention: Group A: DCR with silicone intubation and application of MMC (0.02%) during surgery Comparison intervention: Group B: DCR with silicone intubation |
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Outcomes |
Measured outcomes:
Adverse events: none |
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Identification |
Author name: Firoozeh Raygan Institution: Farabi Eye Hospital Email: fraygan@gmail.com |
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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 | Randomization methods not reported. No sequence generation technique described in the text. |
Allocation concealment (selection bias) | Unclear risk | No allocation concealment described in the study. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported whether participants were blinded. Personnel were not masked due to the nature of the procedure. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Masking of outcome assessors was not reported. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Participant attrition rate is not reported. |
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'. |