The purpose of this study was to compare the efficacy and tolerability of diclofenac-gentamicin combination eye drops with that of diclofenac eye drops in the postoperative management of patients undergoing extracapsular cataract surgery and lens implantation. This was a prospective, randomised, investigatormasked, parallel-group, 4-week, multicentre study with patient visits preoperatively, on the day of surgery and postoperatively on days 1, 5 to 8, 12 to 16, and 26 to 32. A total of 295 patients (146 diclofenac-gentamicin, 149 diclofenac) were enrolled and randomised in the study. The two treatment groups were similar at baseline. The magnitude of intraocular inflammation, as assessed by the sum of the grades of anterior chamber flare and cells, reduced markedly in both the study groups with no statistically significant difference between the two groups at any postoperative visit (days 5 to 8, p equals; 0.91; days 12 to 16, p equals; 0.79; and days 26 to 32, p equals; 0.56). There was no statistically significant difference between the diclofenac-gentamicin and diclofenac groups in the global assessment of local tolerance, as assessed by the sum of grades of burningsol;stinging and blurred vision, at any of the postoperative visits. In conclusion, diclofenac-gentamicin eye drops were as effective as diclofenac eye drops and appeared to be acceptably tolerated in the control of post-cataract surgery inflammation.
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