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

Eshraghy 2012.

Methods Study design: randomized controlled trial, parallel group
Unit of analysis: participants
Number randomized: 88 in total, 42 in Group A, 46 in Group B
Number of arms: 2
Enrollment start year: 2008
Length of follow‐up: average of 10 months (range 6 to 15 months)
Sample size calculations: not reported
Losses to follow‐up: none
Participants Country: Iran
Age (mean (SD)): 50.7 (8.9) in Group A, 49.5 (9.9) in Group B
Females (n (%)): 41 (46.6) in total, 19 (45.2) in Group A, 22 (47.9) in Group B
Inclusion criteria: history of dacryocystitis in past 3 months, inappropriate lacrimal sac or nasal mucosal sac
Exclusion criteria: tearing secondary to identifiable and treatable causes (e.g. dry eye, trichiasis, entropion or ectropion, common canaliculus obstruction, fracture of the facial bones, tumor of the eyelid or the lacrimal sac), previously failed DCR surgery
Study group differences: group differences in age were not statistically significant
Interventions Intervention: Group A: DCR with silicone intubation and application of MMC (0.02%) during surgery
Comparison intervention: Group B: DCR with silicone intubation
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: Firoozeh Raygan
Institution: Farabi Eye Hospital
Email: fraygan@gmail.com
Notes Funding source: not reported
Declarations of interest: none
Trial registration number: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomization methods not reported. No sequence generation technique described in the text.
Allocation concealment (selection bias) Unclear risk No allocation concealment described in the study.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not reported whether participants were blinded. Personnel were not masked due to the nature of the procedure.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Masking of outcome assessors was not reported.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Participant attrition rate is not reported.
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'.