Comparing the efficacy of mydriatic cocktail-soaked sponge and conventional pupil dilation in patients using tamsulosin – a randomized controlled trial

BACKGROUND: A strong association exists between the use of tamsulosin and the occurance of intraoperative floppy iris syndrome. Several methods were advocated to overcome the progressive intraopertive miosis. Our purpose was to investigate the effect of a mydriatic-cocktail soaked cellulose sponge on perioperative pupil diameter in tamsulosin-treated patients undergoing elective cataract surgery. METHODS: Patients using tamsulosin were dilated either with mydriatic-cocktail soaked sponge (group 1) or with conventional eyedrop regimen (group 2). Control patients not taking any α(1) adrenergic receptor inhibtors were also dilated with mydriatic sponge (group 3). In all groups oxybuprocain 0.4%, cocain 4%, tropicamide 1%, phenylephrine 10%, diclophenac 0.1% along with chloramphenicol 0.5% were used preoperatively. Pupil diameter (mm) was measured preoperatively, after nucleus delivery, and before IOL implantation. Adverse effects associated with the use of sponge, minor and major intraoperative complications, the use of iris retractors and operation time were recorded. Differences in general between groups were analyzed with a one way analysis of variance (ANOVA); differences between groups in proportions were assessed by Fisher’s exact test. RESULTS: Mean pupil diameter (mm) was preopertively: 7.52 ± 1.21, 7.30 ± 1.55 and 7.99 ± 0.96 (ANOVA: p = 0.079); after nucleus delivery: 6 ± 1.20, 6.29 ± 1.12 and 6.52 ± 0.81 (ANOVA: p = 0.123); before IOL implantation: 5.46 ± 1.06, 5.83 ± 1.09 and 6.17 ± 0.89 (ANOVA: p = 0.0291). No adverse effect related to sponge use was detected. Frequency of minor complications, and iris hook use was similar in the two tamsulosin treated group. Operation time did not differ significantly in the three groups. CONCLUSION: We have found that using a mydriatic cocktail-soaked wick – an alternative way to achieve intraoperative mydriasis for cataract surgery – was as effective and safe as the conventional repeated eyedrops regiment for tamsulosin treated patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN37834752