Skip to main content
. 2020 Apr 7;2020(4):CD012309. doi: 10.1002/14651858.CD012309.pub2

Bakri 2003.

Methods Study design: randomized controlled trial, parallel group
Unit of analysis: eyes
Number randomized: 201 total eyes, 103 in the fluorouracil group, 98 in the endonasal laser dacryocystorhinostomy (ELDCR) with isotonic saline group
Number of arms: 2
Enrollment start year: not reported
Length of follow‐up: 12 months or later
Sample size calculations: not reported
Losses to follow‐up: not reported
Participants Country: England
Age (mean (SD)): 66 (NR) total
Females (n (%)): 50 (63) in the ELDCR group, 51 (67) in the ELDCR with isotonic saline group
Inclusion criteria: evidence of primary acquired nasolacrimal duct obstruction, symptoms severe enough to require surgery
Exclusion criteria: not reported
Study group differences: not reported
Interventions Intervention: ELDCR surgery with application of 0.5 mg/mL FU
Comparison intervention: ELDCR surgery with application of isotonic sodium chloride solution
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: none
Identification Author name: Karim Bakri
Institution: University Hospital
Email: nick.jones@nottingham.ac.uk
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) Low risk Authors do not specify how participants were randomized, only that "randomization was performed in the pharmacy department".
Allocation concealment (selection bias) Low risk "randomization was performed in the pharmacy department." "Surgeons and patients remained masked to the choice of treatment until the study and follow‐up had been completed", hence we determined that treatment allocation was concealed de facto.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk "Surgeons and patients remained masked to the choice of treatment until the study and follow‐up had been completed"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Masking of outcome assessors was not reported.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Article provides insufficient information regarding time points. Follow‐up time was 12 months or longer, but that could have been anywhere between 12 and 60 months (for the control) or 12 and 48 months (for the intervention). As‐treated analysis was conducted: "This figure may partly reflect a subgroup of patients who did not attend because their symptoms had been relieved. However... these patients were excluded from the statistical analysis".
Selective reporting (reporting bias) Unclear risk Study mentions a protocol, but none accessible for comparison with published study. The conclusions state that: "The study sought to determine whether the application of topical fluorouracil reduced scar formation and improved patency rates"; only patency rates (via epiphora) and postoperative levels of fluorouracil were reported in the results.
Other bias Low risk Study appears to be free of other sources of bias.