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

Penttilä 2011.

Methods Study design: randomized controlled trial, parallel group
Unit of analysis: eyes
Number randomized: 30 in total, 15 per group
Number of arms: 2
Enrollment start year: 2004
Length of follow‐up: 6 months
Sample size calculations: not reported
Losses to follow‐up: 2 (6.25%) lost to follow‐up (reasons and groups not reported)
Participants Country: Finland
Age (mean (SD)): 65 (11) in the MMC group, 70 (10) in the EN‐DCR only group
Females (n (%)): 27 (90) in total, 13 (86.7) in the MMC group, 14 (93.3) in the EN‐DCR only group
Inclusion criteria: aged 18 years, American Society of Anesthesiologist physical status was I‐III, scheduled for revision lacrimal pathway surgery due to tearing or recurrent infection after failed EX‐DCR or EN‐DCR
Exclusion criteria: presaccal obstruction; malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway; mental disability; pregnancy; breastfeeding
Study group differences: not significant
Interventions Intervention: EN‐DCR with application of 0.4 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

  • ocular symptom score

  • Nasolacrimal Duct Obstruction Symptom Score


Adverse events: additional surgery for abnormalities
Identification Author name: Elina Penttila
Institution: Department of Otorhinolaryngology at Kuopio University Hospital
Email: grigori.smirnov@kuh.fi
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) Low risk "The allocation was computer‐generated and a sealed opaque envelope method was used to ensure blinding."
Allocation concealment (selection bias) Low risk "The allocation was computer‐generated and a sealed opaque envelope method was used to ensure blinding."
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 Unclear risk Masking of outcome assessors was not reported.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Intention‐to‐treat analysis was not followed: 2/32 (6.25%) participants were withdrawn and not included in the final analysis, however we determined that this was unlikely to have impacted on the results.
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'.