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 |
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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 |
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Interventions |
Intervention: EN‐DCR with 0.5 mg/mL MMC application and canalicular silicone intubation Comparison intervention: EN‐DCR with canalicular silicone intubation |
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Outcomes |
Measured outcomes:
Adverse events: none |
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Identification |
Author name: Mahmut Ozkiris Institution: Bozok University Medical Faculty Email: mozkiris@yahoo.com |
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Notes |
Funding source: not reported Declarations of interest: none Trial registration number: not reported |
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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'. |