Topical naproxen sodium for inhibition of miosis during cataract surgery. Prospective, randomized clinical trials

V. Papa, S. Russo, P. Russo, A. Di Bella, M. Santocono, G. Milazzo, A. Caporossi, F. Ponte, G. Anselmetti, S. Azzaro, N. Bonanno, G. Caprioglio, P. D'Arrigo, E. Gandolfo, R. Ratiglia, A. Reibaldi, A. Scialfa, F. Zagari

Research output: Contribution to journalArticle

10 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)292-296
Number of pages5
JournalEye (London, England)
Volume16
Issue number3
DOIs
Publication statusPublished - 2002

Fingerprint

Miosis
Naproxen
Cataract
Randomized Controlled Trials
Diclofenac
Mydriasis
Aqueous Humor
Ophthalmic Solutions
Placebos
Pupil
Phacoemulsification
Cataract Extraction
Ambulatory Surgical Procedures
Double-Blind Method
Cornea
Epinephrine
Salts
Therapeutics

Keywords

  • Aqueous humor
  • Cataract surgery
  • Mydriasis
  • Naproxen
  • NSAID

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems

Cite this

Papa, V., Russo, S., Russo, P., Di Bella, A., Santocono, M., Milazzo, G., ... Zagari, F. (2002). Topical naproxen sodium for inhibition of miosis during cataract surgery. Prospective, randomized clinical trials. Eye (London, England), 16(3), 292-296. https://doi.org/10.1038/sj.eye.6700124

Topical naproxen sodium for inhibition of miosis during cataract surgery. Prospective, randomized clinical trials. / Papa, V.; Russo, S.; Russo, P.; Di Bella, A.; Santocono, M.; Milazzo, G.; Caporossi, A.; Ponte, F.; Anselmetti, G.; Azzaro, S.; Bonanno, N.; Caprioglio, G.; D'Arrigo, P.; Gandolfo, E.; Ratiglia, R.; Reibaldi, A.; Scialfa, A.; Zagari, F.

In: Eye (London, England), Vol. 16, No. 3, 2002, p. 292-296.

Research output: Contribution to journalArticle

Papa, V, Russo, S, Russo, P, Di Bella, A, Santocono, M, Milazzo, G, Caporossi, A, Ponte, F, Anselmetti, G, Azzaro, S, Bonanno, N, Caprioglio, G, D'Arrigo, P, Gandolfo, E, Ratiglia, R, Reibaldi, A, Scialfa, A & Zagari, F 2002, 'Topical naproxen sodium for inhibition of miosis during cataract surgery. Prospective, randomized clinical trials', Eye (London, England), vol. 16, no. 3, pp. 292-296. https://doi.org/10.1038/sj.eye.6700124
Papa, V. ; Russo, S. ; Russo, P. ; Di Bella, A. ; Santocono, M. ; Milazzo, G. ; Caporossi, A. ; Ponte, F. ; Anselmetti, G. ; Azzaro, S. ; Bonanno, N. ; Caprioglio, G. ; D'Arrigo, P. ; Gandolfo, E. ; Ratiglia, R. ; Reibaldi, A. ; Scialfa, A. ; Zagari, F. / Topical naproxen sodium for inhibition of miosis during cataract surgery. Prospective, randomized clinical trials. In: Eye (London, England). 2002 ; Vol. 16, No. 3. pp. 292-296.
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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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AU - Russo, S.

AU - Russo, P.

AU - Di Bella, A.

AU - Santocono, M.

AU - Milazzo, G.

AU - Caporossi, A.

AU - Ponte, F.

AU - Anselmetti, G.

AU - Azzaro, S.

AU - Bonanno, N.

AU - Caprioglio, G.

AU - D'Arrigo, P.

AU - Gandolfo, E.

AU - Ratiglia, R.

AU - Reibaldi, A.

AU - Scialfa, A.

AU - Zagari, F.

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N2 - 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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