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

Wadhera 2013.

Methods Study design: randomized controlled trial, parallel group
Unit of analysis: participants
Number randomized: 50 in total, 25 per group
Number of arms: 2
Enrollment start year: 2004
Length of follow‐up: 1 year
Sample size calculations: not reported
Losses to follow‐up: none
Participants Country: India
Age (mean (SD)): 32.4 (10.28) in the MMC group, 33.2 (9.3) in the EN‐DCR alone group
Females (n (%)): 10 (25) in the MMC group, 8 (32) in the EN‐DCR alone group
Inclusion criteria: aged 16 to 50 years, symptoms and signs suggestive of nasolacrimal duct blockage refractory to conventional medical treatment
Exclusion criteria: marked deviation of nasal septum on same side, chronic sinusitis, nasal polyps, severe bony deformity of lacrimal sac fossa (post‐traumatic), bleeding disorders, nasal tumors, history of previous DCR
Study group differences: no differences
Interventions Intervention: EN‐DCR with application of 0.5 mg/mL MMC
Comparison intervention: EN‐DCR
Outcomes Measured outcomes:
  • functional success, defined as the relief of epiphora

  • anatomic success, defined as patency to lacrimal irrigation


Adverse events: mild postoperative bleeding
Identification Author name: Raman Wadhera
Institution: Graduate Institute of Medical Sciences
Email: dr.wadhera@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) Unclear risk "They were assigned randomly into two groups of 25 patients each". Method of random sequence generation was not reported.
Allocation concealment (selection bias) Unclear risk Method of treatment 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 Unclear risk Masking of 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'.