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

Tirakunwichcha 2011.

Methods Study design: randomized controlled trial, parallel group
Unit of analysis: participants
Number randomized: 50 in total, 26 in the MMC group, 24 in the EN‐DCR alone group
Number of arms: 2
Enrollment start year: 2004
Length of follow‐up: 12 months
Sample size calculations: not reported
Losses to follow‐up: none
Participants Country: Thailand
Age (mean (SD)): 44.6 (NR) in total, 44.3 (6.47) in the MMC group, 44.9 (6.87) in the EN‐DCR alone group
Females (n (%)): 41 (82) in total, 22 (84.6) in the MMC group, 19 (79.2) in the EN‐DCR alone group
Inclusion criteria: patients with primary acquired nasolacrimal duct obstruction
Exclusion criteria: secondary causes of obstruction and canalicular obstructions
Study group differences: no differences
Interventions Intervention: EN‐DCR with application of 0.5 mg/mL MMC
Comparison intervention: EN‐DCR with application of placebo
Outcomes Measured outcomes:
  • functional success, defined as disappearance of the tearing

  • anatomic success, defined as patency to lacrimal irrigation via syringing irrigation without fluid reflux

  • ostium size on nasal endoscopy at 6 months postoperatively


Adverse events: none
Identification Author name: Suppapong Tirakunwichcha
Institution: Chulalongkorn University
Email: suppapong.t@chula.ac.th
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 Participants were randomized using a "block of four randomization, which was prepared in advance and concealed in 50 envelopes (in chronological order) by an independent ophthalmologist".
Allocation concealment (selection bias) Low risk "The patients were then allocated into the treatment group .... using the block of four randomization, which was prepared in advance and concealed in 50 envelopes (in chronological number) by another ophthalmologist (S.S.) who was not involved in the surgical process and outcome evaluation."
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk "Double‐masked" study: "The 0.5 mg/ml mitomycin C solution and the placebo were prepared in the same color for each patient by the assigned scrub nurse who cooperated with the ophthalmologist (S.S.) who knew which group the patient was in, and the solution was served to the surgeon in the operating field. The endonasal endoscopic DCR was performed by the otolaryngologist (A.S.). The surgeon was masked to the intervention and only yielded to assess the outcomes."
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Postoperative eye symptoms were assessed by the ophthalmologist (TS), and ostium sizes were measured by the otolaryngologist (AS). The collected data gathered by the ophthalmologist (SS) were disclosed after the 1‐year follow‐up visit.
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'.