PURPOSE: To assess corneal penetration of naproxen sodium and its efficacy in maintaining intraoperative mydriasis during cataract surgery. METHODS: Two double blind studies have been performed comparing the efficacy of naproxen ophthalmic solution to that of placebo or diclofenac in inhibiting pre-operative miosis. Study No. 1 was a placebo-controlled study and involved 194 patients undergoing extracapsular cataract extraction. Study No. 2 was an active-controlled study (vs diclofenac) concerning 214 patients undergoing phacoemulsification. In both studies treatment started the day before surgery. A balanced salt solution containing adrenaline was used in all patients. Pupil size was measured prior to the corneal section and at the end of surgery. An aqueous humor sample was taken immediately before corneal incision in a subset of 20 patients to measure naproxen aqueous concentration. RESULTS: In both studies the pupillary diameter decreased during surgery within each treatment group in a statistically significant manner (P < 0.001). Naproxen was more effective than placebo (P < 0.01) and as effective as diclofenac in controlling pupil diameter regression during cataract. Mean concentration level of naproxen in the aqueous humor was 372.3 ng/ml. CONCLUSIONS:Naproxen sodium ophthalmic solution penetrates the cornea and it is effective in maintaining intraoperative mydriasis.
RCT Entities:
PURPOSE: To assess corneal penetration of naproxen sodium and its efficacy in maintaining intraoperative mydriasis during cataract surgery. METHODS: Two double blind studies have been performed comparing the efficacy of naproxen ophthalmic solution to that of placebo or diclofenac in inhibiting pre-operative miosis. Study No. 1 was a placebo-controlled study and involved 194 patients undergoing extracapsular cataract extraction. Study No. 2 was an active-controlled study (vs diclofenac) concerning 214 patients undergoing phacoemulsification. In both studies treatment started the day before surgery. A balanced salt solution containing adrenaline was used in all patients. Pupil size was measured prior to the corneal section and at the end of surgery. An aqueous humor sample was taken immediately before corneal incision in a subset of 20 patients to measure naproxen aqueous concentration. RESULTS: In both studies the pupillary diameter decreased during surgery within each treatment group in a statistically significant manner (P < 0.001). Naproxen was more effective than placebo (P < 0.01) and as effective as diclofenac in controlling pupil diameter regression during cataract. Mean concentration level of naproxen in the aqueous humor was 372.3 ng/ml. CONCLUSIONS:Naproxen sodium ophthalmic solution penetrates the cornea and it is effective in maintaining intraoperative mydriasis.