Wadhera 2013.
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: 2004 Length of follow‐up: 1 year Sample size calculations: not reported Losses to follow‐up: none |
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Participants |
Country: India Age (mean (SD)): 32.4 (10.28) in the MMC group, 33.2 (9.3) in the EN‐DCR alone group Females (n (%)): 10 (25) in the MMC group, 8 (32) in the EN‐DCR alone group Inclusion criteria: aged 16 to 50 years, symptoms and signs suggestive of nasolacrimal duct blockage refractory to conventional medical treatment Exclusion criteria: marked deviation of nasal septum on same side, chronic sinusitis, nasal polyps, severe bony deformity of lacrimal sac fossa (post‐traumatic), bleeding disorders, nasal tumors, history of previous DCR Study group differences: no differences |
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Interventions |
Intervention: EN‐DCR with application of 0.5 mg/mL MMC Comparison intervention: EN‐DCR |
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Outcomes |
Measured outcomes:
Adverse events: mild postoperative bleeding |
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Identification |
Author name: Raman Wadhera Institution: Graduate Institute of Medical Sciences Email: dr.wadhera@yahoo.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 | "They were assigned randomly into two groups of 25 patients each". Method of random sequence generation was not reported. |
Allocation concealment (selection bias) | Unclear risk | Method of treatment 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'. |