medigraphic.com
Anales de la Sociedad Mexicana de Oftalmología y Archivos de la Asociación Para Evitar la Ceguera en México

2007, Number 4

Next >>

Rev Mex Oftalmol 2007; 81 (4)

Estudio multicéntrico comparativo de dos diferentes fórmulas de ciprofloxacino y dexametasona en combinación fija en facoemulsificación

Baiza-Durán LM, González JR, López-Star B, Gómez-Bastar P, Arroyo-Muñoz L, Ávalos-Urzua G, Chávez-Mondragón E, Domene-Hinojosa JL

Language: Spanish
References: 27
Page: 189-194
PDF size: 70.96 Kb.


ABSTRACT

Objective: To evaluate the efficacy and safety of a topic ophthalmic solution of dexamethasone and ciprofloxacin as fixed combination versus a topic ophthalmic suspension of dexamethasone and ciprofloxacin as fixed combination in the treatment of inflammation and prophylaxis for infection after cataract surgery with phacoemulsification technique.
Materials and methods: A prospective, randomized, multi-centric, double blind, masked, longitudinal clinical trial was performed. We included 100 patients (100 eyes) with cataract diagnoses. In a randomized way an ophthalmic solution of dexamethasone and ciprofloxacin in fixed combination or an ophthalmic suspension of dexamethasone and ciprofloxacin as fixed combination were applied four times a day during 15 days after the surgical procedure. Subsequent evaluations were made at days 2,7,14 and 30 of the study evaluating the safety, efficacy and tolerance.
Results: There were no statitistical differences between both groups related to safety and efficacy, nor any case of endophthalmitis.
Conclusions: The results of this study indicate that Sophixin DX Ofteno® is as safe and efficacious as Cilodex® for postoperative infectious prophylaxis and diminishing the ocular inflammation after cataract surgery with phacoemulsification.


REFERENCES

  1. Kleiman NJ, Worgul BV. Lens. En: Tasman W, Jaeger EA (eds.). Duane’s Foundations of Clinical Ophthalmology 1994; Vol. 1, Chap. 15: 26-33.

  2. Charlton JF: Cataract surgery. En: Tasman W, Jaeger EA (eds.). Duane’s Clinical Ophthalmology 1992; Vol. 6, Chap. 6:1-43.

  3. Schechter RJ. Optics of intraocular lenses. En: Tasman W, Jaeger EA (eds.). Duane’s Clinical Ophthalmology 1991; Vol. 1, Chap. 68.

  4. Comeron JD. Surgical and nonsurgical trauma. En: Tasman W, Jaeger EA (eds.): Duane’s Foundations of Clinical Ophthalmology 1988; Vol. 3, Chap. 6.

  5. Bettman JW Jr: Pathology of complications of intraocular surgery. Am J Ophthalmology 1969; 68:1037.

  6. Somani S, Grinbaum A, Slomovic A. Postoperative endophthalmitis: incidence, predisposing surgery, clinical course and outcome. Can J Ophthalmol 1997; 32: 303-310.

  7. Allen HF, Mangiaracine AB. Bacterial endophthalmitis after cataract extraction. Arch Ophthalmol 1964; 72:454-462.

  8. Staudenmaier C. Current views on the prevention of postoperative infectious endophthalmitis. Can J Ophthalmol 1997; 32:297-302.

  9. Starr MB, Lally JM: Antimicrobial prophylaxis for ophthalmic surgery. Surv Ophthalmol 1995; 39:485-501.

  10. Chrai SS, Makoid MC, Eriksen SP, Robinson JR. Lacrimal and instilled fluid dynamics in rabbit eyes. J Pharm Sci 1973; 62:1112.

  11. Chrai SS, Makoid MC, Eriksen SP, Robinson JR. Drop size and initial dosing frecuency problems of topically applied ophthalmic drugs. J Pharm Sci 1974; 63: 333.

  12. Lee VH, Robinson JR. Review. Topical ocular drug delivery: Recent developments and future challenges, J Ocul Pharmacol 1986; 2: 67.

  13. Mikkelson TJ, Chrai SS, Robinson JR. Competitive inhibition of drug-protein interaction in eye fluids and tissues. J Pharm Sci 1973; 62: 1942.

  14. Ferro-Montiu J. Endoftalmitis post cirugía de catarata: prevención y tratamiento. Arch Soc Esp Oftalmol 2003; 8.

  15. Schechter RJ: Optics of intraocular lenses. En: Tasman W, Jaeger EA (eds.). Duane’s Clinical Ophthalmology 1991; Vol. 1, Chap. 68.

  16. http://www.medscape.com/druginfo/monograph?cid=med&drugid=75004&drugname=dexamethasone+Opht+&monotype

  17. Leibowitz HM. Clinical evaluation of ciprofloxacin 0.3% ophthalmic solution for treatment of bacterial keratitis. Am J Ophthalmol 1991; 112(Supl):34S-47S.

  18. Steinert RF: Current therapy for bacterial keratitis and bacterial conjuntivitis. Am J Ophthalmol 1991; 112(Supl):10S-14S.

  19. Cokingtin CD, Hyndiuk RA. Insights from experimental data on ciprofloxacin in the treatment of bacterial keratitis and ocular infections. Am J Ophthalmol 1991; 112(Supl):25S-28S.

  20. Diamond JP, White L, Leeming JP, Hoh HB, Easty DL. Topical 0.3% ciprofloxacin, norfloxacin, and ofloxacin in treatment of bacterial keratitis: a new method for comparative evaluation of ocular drug penetration. Br J Ophthalmol 1995; 79: 606-609.

  21. Schlüter G. Toxicology of ciprofloxacin. 1st International Ciprofloxacin Workshop, Exerpta Media 1986; 61-69.

  22. Schlüter G. Toxicology of ciprofloxacin. 1st International Ciprofloxacin Workshop, Exerpta Media 1986; 61-69.

  23. Yolton DP. Anti-infective drugs. En: Barlett JD, Jaanus SD (eds.). Clinical Ocular Pharmacology. Butterwoth-Heinemann, Newton, 1995; 279-281.

  24. Colleaux KM, Hamilton K. Effect of prophylactic antibiotics and incision type on the incidence of endophthalmitis after cataract surgery. Can J Ophthalmol 2000; 35: 373-8.

  25. Urban RC, Cotlier E. Corticosteroids-induced cataracts. Surv Ophthalmol 1986; 31:102-110.

  26. Vitale A, Foster S. Pharmacology of medical therapy for uveitis. En: Zimmerman TJ, Kooner KJ, Shariri M (eds.). Textbook of Ocular Pharmacology, Lippincott-Raven, Philadelphia 1997; Chap 59.

  27. Armaly MF. Effects of corticosteroids on intraocular pressure and fluid dynamics. I. The effect of dexamethasone in the normal eye. Arch Ophthalmol 1963; 70:482-491.




2020     |     www.medigraphic.com