Dk. Chitkara et al., DICLOFENAC-GENTAMICIN COMBINATION EYE DROPS VS DICLOFENAC EYE DROPS AFTER CATARACT-SURGERY, Clinical drug investigation, 14(4), 1997, pp. 247-251
The purpose of this study was to compare the efficacy and tolerability
of diclofenac-gentamicin combination eye drops with that of diclofena
c eye drops in the postoperative management of patients undergoing ext
racapsular cataract surgery and lens implantation. This was a prospect
ive, randomised, investigator-masked, parallel-group, 4-week, multicen
tre study with patient visits preoperatively, on the day of surgery an
d postoperatively on days 1, 5 to 8, 12 to 16, and 26 to 32. A total o
f 295 patients (146 diclofenac-gentamicin, 149 diclofenac) were enroll
ed 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 ma
rkedly in both the study groups with no statistically significant diff
erence between the two groups at any postoperative visit (days 5 to 8,
p = 0.91; days 12 to 16, p = 0.79; and days 26 to 32, p = 0.56). Ther
e was no statistically significant difference between the diclofenac-g
entamicin and diclofenac groups in the global assessment of local tole
rance, as assessed by the sum of grades of burning/stinging and blurre
d vision, at any of the postoperative visits. In conclusion, diclofena
c-gentamicin eye drops were as effective as diclofenac eye drops and a
ppeared to be acceptably tolerated in the control of post-cataract sur
gery inflammation.