Qadir 2014.
Methods |
Study design: randomized controlled trial, parallel group Unit of analysis: participants Number randomized: 50 in total, 25 per group Number of arms: 2 Enrollment start year: not reported Length of follow‐up: 6 months Sample size calculations: not reported Losses to follow‐up: none |
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Participants |
Country: India Age (mean (SD)): 43 (12.6) in the MMC group, 47.3 (11.5) in the EX‐DCR alone group Females (n (%)): 36 (72) in total, 19 (76) in the MMC group, 17 (68) in the EX‐DCR alone group Inclusion criteria: patients with primary acquired nasolacrimal duct obstruction Exclusion criteria: presaccal obstructions, acute dacryocystitis, chronic granulomatous condition, longstanding chronic dacryocystitis with fibrosis of sac, chronic dacryocystitis with fistula, ectropion, entropion, nasal conditions like severe deviated nasal septum, atrophic rhinitis, previous failure of DCR Study group differences: no significant difference in ages; female preponderance in the study but no significant between‐group differences |
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Interventions |
Intervention: EX‐DCR with application of 0.2 mg/mL MMC Comparison intervention: EX‐DCR |
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Outcomes |
Measured outcomes:
Adverse events: injury to nasal mucosa, sac injury, severe bleeding, epistaxis, wound infection |
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Identification |
Author name: Andleeb Ahangar Institution: Department Of Ophthalmology, Government Medical College Srinagar Email: andleebali@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 | Method of random sequence generation was not reported. |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment was not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Masking of participants and personnel was not reported. |
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 | 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'. |