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

Kao 1997.

Methods Study design: randomized controlled trial, parallel group
Unit of analysis: eyes
Number randomized: 15 eyes (of 14 participants), 7 eyes in the MMC group, 8 eyes in EX‐DCR alone group
Number of arms: 2
Enrollment start year: 1994
Length of follow‐up: 6 months
Sample size calculations: not reported
Losses to follow‐up: none
Participants Country: Taiwan
Age (mean (SD)): 55 (9.5) in the MMC group, 52 (14.7) in the EX‐DCR alone group
Females (n (%)): not reported
Inclusion criteria: patients with primary acquired nasolacrimal duct obstruction
Exclusion criteria: not reported
Study group differences: not reported
Interventions Intervention: EX‐DCR with 0.2 mg/mL MMC application during surgery
Comparison intervention: EX‐DCR alone
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

  • complications


Adverse events: septo‐osteotomy adhesion
Identification Author name: Shine CS Kao
Institution: National Taiwan University Hospital
Email: not reported
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 Method of random sequence generation was not reported.
Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported.
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 Low risk "All the calculations were done by one of our staff members who did not know whether he was looking at a photograph of a mitomycin C group or a control group patient." Masking of other outcome assessors was not reported.
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'.