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

Gonzalvo 2000.

Methods Study design: randomized controlled trial, parallel group
Unit of analysis: participants
Number randomized: 30 in total, 15 per group
Number of arms: 2
Enrollment start year: 1996
Length of follow‐up: 6 months
Sample size calculations: not reported
Losses to follow‐up: not reported
Participants Country: Spain
Age (mean (SD)): 48.11 (11.77) in total, 52.33 (4.82) in the MMC group, 43.5 (15.2) in the EX‐DCR alone group
Females (n (%)): 11 (64) in total, 6 (75) in the MMC group, 5 (55) in the EX‐DCR alone group
Inclusion criteria: patients with nasolacrimal duct obstruction after previous canaliculation
Exclusion criteria: none
Study group differences: not reported
Interventions Intervention: EX‐DCR with MMC (0.2 mg/mL) 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


Adverse events: development of herpes zoster of cranial nerve V
Identification Author name: Francisco Jose Gonzalvo Ibanez
Institution: Hospital Universitario Miguel Servet
Email: not reported
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 The random component in the sequence generation process was not described.
Allocation concealment (selection bias) Unclear risk The method of concealment was not described.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Although participants and outcome assessors did not have knowledge of the groups to which participants had been assigned, masking of study personnel was not reported.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "The patient and the outcome assessor did not have knowledge of the group designated to each patient"
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'.