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

Ozkiris 2012.

Methods Study design: randomized controlled trial, parallel group
Unit of analysis: participants
Number randomized: 36 in total, 18 per group
Number of arms: 2
Enrollment start year: 2007
Length of follow‐up: mean of 11.5 months in the MMC group, mean of 12.7 months in the EN‐DCR alone group (overall range of 6 to 22 months)
Sample size calculations: not reported
Losses to follow‐up: none
Participants Country: Turkey
Age (mean (SD)): 37.2 (10.2) in total
Females (n (%)): 15 (41.7) in total, 7 (38.8) in the MMC group, 8 (44.4) in the EN‐DCR alone group
Inclusion criteria: unilateral or bilateral nasolacrimal duct obstruction proven by nasolacrimal duct irrigation, aged > 18 years, previous history of DCR surgery, follow‐up of at least 6 months
Exclusion criteria: distal canalicular or common canalicular obstruction on dacryocystography, patients with eyelid or sac abnormality, cases with suspicion of malignancy, previous radiation therapy, post‐traumatic lids/bony deformity, proximal obstruction, nasal structural abnormalities, severe atrophic rhinitis
Study group differences: not reported
Interventions Intervention: EN‐DCR with 0.5 mg/mL MMC application and canalicular silicone intubation
Comparison intervention: EN‐DCR with canalicular silicone intubation
Outcomes Measured outcomes:
  • functional success, defined as the relief of epiphora

  • anatomic success, defined as patency to lacrimal irrigation


Adverse events: none
Identification Author name: Mahmut Ozkiris
Institution: Bozok University Medical Faculty
Email: mozkiris@yahoo.com
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 Randomized by computer random number generator.
Allocation concealment (selection bias) Unclear risk Allocation concealment procedure not reported.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants were masked to assigned group; although personnel were not (no placebo was used), this probably did not affect outcome.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "Patients were examined with an endoscope 2 days after surgery, after 1 week, and monthly thereafter for a minimum of 6 months by another surgeon (S.G.) who was blinded to the operation technique performed. Both subjective and objective assessments were performed"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All participants were analyzed in the group to which they had been randomized.
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'.