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

Roozitalab 2004.

Methods Study design: randomized controlled trial, parallel group
Unit of analysis: participants
Number randomized: 130 in total, 65 per group
Number of arms: 2
Enrollment start year: 2001
Length of follow‐up: 6 months
Sample size calculations: not reported
Losses to follow‐up: none
Participants Country: Iran
Age (mean (SD)): 40 (15) in the MMC group, 42 (16) in the EX‐DCR group
Females (n (%)): 89 (68.5) in total, 49 (75) in the MMC group, 40 (62) in the EX‐DCR group
Inclusion criteria: diagnosis of nasolacrimal duct obstruction (congenital and acquired)
Exclusion criteria: not reported
Study group differences: no significant difference in age
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

  • anatomic success, defined as patency to lacrimal irrigation


Adverse events: none
Identification Author name: MR Namazi
Institution: Shiraz University of Medical Sciences
Email: Namazi_mr@yahoo.com
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 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 Low risk All the examinations were done by the second author, who was masked to the procedures.
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'.