Ahmad 2002.
Methods |
Study design: randomized controlled trial, parallel group Unit of analysis: eyes Number randomized: 44 total, 22 per group Number analyzed: 44 total, 22 per group Number of arms: 2 Enrollment start year: 1999 Length of follow‐up: more than 9 months Sample size calculations: not reported Losses to follow‐up: none |
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Participants |
Country: India Age (mean (SD)): 45.4 (NR) in the MMC group; 44.9 (NR) in the EX‐DCR alone group Females (n (%)): not reported Inclusion criteria: diagnosis of primary acquired nasolacrimal duct obstruction Exclusion criteria: not reported 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: fibrous tissue growth, scarring or granulation tissue formation, delayed wound healing |
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Identification |
Author name: Sheikh Sajjad Ahmad Institution: SKIMS Medical College 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 | Method of random sequence generation was not reported. |
Allocation concealment (selection bias) | Unclear risk | Treatment allocation concealment was not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Although it seems participants were masked to treatment, the operating doctor knew the treatment group (using an applicator versus not using an applicator). |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Authors state that: "All the examinations were done by the same physician with double blind control", but it is unclear whether this means outcome assessors were masked. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition not reported, but participants were analyzed in the group to which they had been randomized. |
Selective reporting (reporting bias) | Unclear risk | Trial not registered, and no protocol available for comparison to ascertain selective outcome reporting. |
Other bias | Low risk | Study appears to be free of other sources of bias. |