Dogan 2013a.
Methods |
Study design: randomized controlled trial, parallel group Unit of analysis: eyes Number randomized: 80 in total, 30 in Group 1, 27 in Group 2, 23 in Group 3 Number of arms: 3 Enrollment start year: 2009 Length of follow‐up: 24 months Sample size calculations: not reported Losses to follow‐up: 3 in Group 1, 2 in Group 2, 3 in Group 3 |
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Participants |
Country: Turkey Age (mean (SD)): 62 (NR) in total, 63.4 (NR) in Group 1, 60.7 (NR) in Group 2, 61.8 (NR) in Group 3 Females (n (%)): 67 (83.7) in total Inclusion criteria: diagnosis of nasolacrimal canal obstruction Exclusion criteria: nasal pathologies (e.g. polyp, carcinoma, or advanced septal deviation), no previous lacrimal surgery, no history of naso‐orbital trauma Study group differences: not reported |
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Interventions |
Intervention 1: Group 1: endocanalicular DCR (ECL‐DCR) with 0.4 mg/mL MMC application during surgery and silicone intubation Intervention 2: Group 2: ECL‐DCR with silicone intubation Comparison intervention: Group 3: ECL‐DCR with 0.4 mg/mL MMC application during surgery |
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Outcomes |
Measured outcomes:
Adverse events: stenosis, premature tube loss, granulation, synechia, infection, hemorrhage |
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Identification |
Author name: Remi Zogan Institution: Bezmialem Vakif University Email: dr.remzidogan@gmail.com |
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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 | Sequence generation was not described in the article. |
Allocation concealment (selection bias) | Unclear risk | No allocation concealment described in the study. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Masking of study personnel and participants was not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Masking of study outcome assessors was not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 failures in Group 1, 3 in Group 2, and 2 in Group 3 were lost to follow‐up. |
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'. |