Abstract
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.
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Acknowledgements
We thank C Gramolini and J Klinger for the statistical analysis of data.
The study was entirely supported by SIFI SpA. None of the authors has a financial interest in the product.
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Appendix
Appendix
Naproxen Study Group
Coordinators:
Aldo Caporossi, Cattedra di Oftalmologia Università di Siena
Francesco Ponte, Cattedra di Oftalmologia Università di Palermo
Principle Investigators:
Giovanni Anselmetti, Divisione di Oculistica Ospedale Maria Vittoria, Torino
Salvatore Azzaro, Divisione di Oculistica Ospedale Civile Vittoria (Ragusa)
Nunzio Bonanno, Divisione di Oculistica Azienda Ospedaliera Papardo, Messina
Giancarlo Caprioglio, Divisone di Oculistica Ospedale Civile, Venezia
Pasquale D’Arrigo, Divisione di Oculistica Ospedale R Margherita, Messina
Enrico Gandolfo, Clinica Oculistica Università di Brescia
Roberto Ratiglia, Clinica Oculistica Università di Milano
Alfredo Reibaldi, Clinica Ocuslitica Università di Catania
Aldo Scialfa, Divisione di Oculistica Ospedale Garibaldi, Catania
Francesco Zagari, Divisione di Oculistica Azienda Ospedaliera Cannizzaro, Catania
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Papa, V., Russo, S., Russo, P. et al. Topical naproxen sodium for inhibition of miosis during cataract surgery. Prospective, randomized clinical trials. Eye 16, 292–296 (2002). https://doi.org/10.1038/sj.eye.6700124
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DOI: https://doi.org/10.1038/sj.eye.6700124
