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. 2020 Apr 7;2020(4):CD012309. doi: 10.1002/14651858.CD012309.pub2

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
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
Interventions Intervention: EX‐DCR with application of 0.2 mg/mL MMC
Comparison intervention: EX‐DCR alone
Outcomes Measured outcomes:
  • functional success, defined as the relief of epiphora, at 3 months and 9 months

  • anatomic success, defined as patency to lacrimal irrigation, at 3 months and 9 months


Adverse events: fibrous tissue growth, scarring or granulation tissue formation, delayed wound healing
Identification Author name: Sheikh Sajjad Ahmad
Institution: SKIMS Medical College
Email: not reported
Notes Funding source: not reported
Declarations of interest: not reported
Trial registration number: not reported
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.