Prasannaraj 2012.
Methods |
Study design: randomized controlled trial, parallel group Unit of analysis: participant Number randomized: 38 participants in total, 17 in the MMC group, 21 in the EN‐DCR alone group Number of arms: 2 Enrollment start year: 2003 Length of follow‐up: 6 months Sample size calculations: "A combined sample size of 38 patients was arrived at by using the power approach with a power of 90% and an assumed effect size of 35% between the mitomycin and control groups" Losses to follow‐up: none |
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Participants |
Country: India Age (mean (SD)): 33.6 (NR) in total Females (n (%)): 22 (57.9) in total Inclusion criteria: diagnosis of chronic dacryocystitis due to primary acquired postsaccal obstruction of the lacrimal apparatus Exclusion criteria: patients aged 15 years or younger, history of previous lacrimal sac surgery Study group differences: not reported |
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Interventions |
Intervention: EN‐DCR with application of 0.2 mg/mL MMC Comparison intervention: EN‐DCR alone |
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Outcomes |
Measured outcomes:
Adverse events: granulations, synechiae, obliterative sclerosis |
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Identification |
Author name: Thomas Prasannaraj Institution: R.L. Jalappa Hospital and Research Centre Email: drtpr@yahoo.com |
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Notes |
Funding source: not reported Declarations of interest: not reported 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 | "Random allocation of patients to the mitomycin group or the control group was done by allowing each patient to choose from a bunch of unbiased chits. This was done after counseling and before admission for surgery." |
Allocation concealment (selection bias) | Unclear risk | No allocation concealment described. Single‐blind study. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "Single‐blind" study, however details regarding masking were not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No description of blinding of outcome assessors. |
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 | Low risk | Study appears to be free of other sources of bias. |