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

Dogan 2013a.

Methods Study design: randomized controlled trial, parallel group
Unit of analysis: eyes
Number randomized: 80 in total, 30 in Group 1, 27 in Group 2, 23 in Group 3
Number of arms: 3
Enrollment start year: 2009
Length of follow‐up: 24 months
Sample size calculations: not reported
Losses to follow‐up: 3 in Group 1, 2 in Group 2, 3 in Group 3
Participants Country: Turkey
Age (mean (SD)): 62 (NR) in total, 63.4 (NR) in Group 1, 60.7 (NR) in Group 2, 61.8 (NR) in Group 3
Females (n (%)): 67 (83.7) in total
Inclusion criteria: diagnosis of nasolacrimal canal obstruction
Exclusion criteria: nasal pathologies (e.g. polyp, carcinoma, or advanced septal deviation), no previous lacrimal surgery, no history of naso‐orbital trauma
Study group differences: not reported
Interventions Intervention 1: Group 1: endocanalicular DCR (ECL‐DCR) with 0.4 mg/mL MMC application during surgery and silicone intubation
Intervention 2: Group 2: ECL‐DCR with silicone intubation
Comparison intervention: Group 3: ECL‐DCR with 0.4 mg/mL MMC application during surgery
Outcomes Measured outcomes:
  • functional success, defined as the relief of epiphora

  • anatomic success, defined as patency to lacrimal irrigation

  • ostium size on nasal endoscopy postoperatively


Adverse events: stenosis, premature tube loss, granulation, synechia, infection, hemorrhage
Identification Author name: Remi Zogan
Institution: Bezmialem Vakif University
Email: dr.remzidogan@gmail.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 Sequence generation was not described in the article.
Allocation concealment (selection bias) Unclear risk No allocation concealment described in the study.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Masking of study personnel and participants was not reported.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Masking of study outcome assessors was not reported.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 2 failures in Group 1, 3 in Group 2, and 2 in Group 3 were lost to follow‐up.
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'.