Hargitai 2013.
Study characteristics | ||
Methods |
Study design: randomized controlled trial, parallel group Loss to follow‐up: not reported Intention‐to‐treat: all participants were analyzed in the groups to which they had been assigned Sample size estimation: with 25 participants in each of 2 groups, a 0.8‐millimeter difference between groups will be recognized by an unpaired t‐test with 80% probability assuming a within‐group standard deviation of approximately 1 mm |
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Participants |
Country: Denmark Setting: hospital Enrollment year: 2012 Baseline characteristics: Topical mydriatics
Depot delivery systems
Overall
Inclusion criteria: male patients taking tamsulosin due to benign prostatic hypertrophy, attending elective cataract surgery Exclusion criteria: previous ocular surgery, posterior synechiae, and the use of drops other than artificial tears Pretreatment: 1‐way ANOVA showed no significant difference between the groups in terms of age |
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Interventions |
Intervention group: oxybuprocaine 0.4%, cocaine 4%, tropicamide 1%, phenylephrine 10%, diclofenac 0.1%, and chloramphenicol 0.5% eyedrops were used preoperatively. Cellulose wicks were prepared and submerged in a mix of the above solutions with 1:1:1:1:1:1 ratio. Comparator: oxybuprocaine 0.4%, cocaine 4%, tropicamide 1%, phenylephrine 10%, diclofenac 0.1%, and chloramphenicol 0.5% eyedrops were used preoperatively. Drops were supplied 3 times with 10‐minute intervals. |
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Outcomes |
Primary outcome: pupil diameter (mm), after nucleus delivery, and before IOL implantation Secondary outcome: not reported Measured outcomes: total intraoperative miosis (mm), mean (SD) |
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Identification |
Author name: János Hargitai Institution: Thy‐Mors Hospital Email: janos.hargitai@rn.dk Address: Department of Ophthalmology, Thy‐Mors Hospital, Højtoftevej 2, Thisted7700, Denmark Clinical Trials Registration Number: not reported |
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Notes |
Comments: 30 participants were dilated using the mydriatics cocktail‐soaked sponge (group 1), and 30 participants were dilated using conventional repeated eyedrops regimen (group 2); there was an additional "control" (non‐randomized) group of 31 participants not receiving any α1 adrenergic receptor antagonist medication who also were dilated with mydriatic‐cocktail soaked sponge. Minor (3/30, 2/28, and 1/31 respectively) and major (1/30, 0/28, and 0/31 respectively) complication rate was similar among all groups. Sponsorship source: not reported Conflict of interest: the authors declare that they have no competing interests |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Authors did not describe how the random sequence was generated. |
Allocation concealment (selection bias) | Low risk | The study group was subdivided randomly into 2 equal‐sized groups (n = 30), using sealed envelope method. |
Masking of participants and personnel (performance bias) | High risk | Masking of participants not described; surgeons were masked. |
Masking of outcome assessment (detection bias) | Unclear risk | Identity and masking of outcome assessors not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data reported for all randomized participants, except for 2 who were excluded because they could not lie flat. |
Selective reporting (reporting bias) | Low risk | Outcomes stated in trial registry same as reported in paper. |