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

Prasannaraj 2012.

Methods Study design: randomized controlled trial, parallel group
Unit of analysis: participant
Number randomized: 38 participants in total, 17 in the MMC group, 21 in the EN‐DCR alone group
Number of arms: 2
Enrollment start year: 2003
Length of follow‐up: 6 months
Sample size calculations: "A combined sample size of 38 patients was arrived at by using the power approach with a power of 90% and an assumed effect size of 35% between the mitomycin and control groups"
Losses to follow‐up: none
Participants Country: India
Age (mean (SD)): 33.6 (NR) in total
Females (n (%)): 22 (57.9) in total
Inclusion criteria: diagnosis of chronic dacryocystitis due to primary acquired postsaccal obstruction of the lacrimal apparatus
Exclusion criteria: patients aged 15 years or younger, history of previous lacrimal sac surgery
Study group differences: not reported
Interventions Intervention: EN‐DCR with application of 0.2 mg/mL MMC
Comparison intervention: EN‐DCR alone
Outcomes Measured outcomes:
  • functional success, defined as the relief of epiphora

  • anatomic success, defined as patency to lacrimal irrigation


Adverse events: granulations, synechiae, obliterative sclerosis
Identification Author name: Thomas Prasannaraj
Institution: R.L. Jalappa Hospital and Research Centre
Email: drtpr@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) Low risk "Random allocation of patients to the mitomycin group or the control group was done by allowing each patient to choose from a bunch of unbiased chits. This was done after counseling and before admission for surgery."
Allocation concealment (selection bias) Unclear risk No allocation concealment described. Single‐blind study.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk "Single‐blind" study, however details regarding masking were not reported.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No description of blinding of outcome assessors.
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 Low risk Study appears to be free of other sources of bias.