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Large study finds Voltaren safe following cataract surgery
No postop complications were specifically associated with the use of Voltaren postoperatively.
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Concerns have been raised regarding the safety of topical nonsteroidal anti-inflammatory drugs (NSAIDs) following cataract surgery due to a number of reports of corneal melting, primarily in association with diclofenac sodium ophthalmic solution (Falcon Pharmaceuticals). Topical NSAIDs have been used to treat ocular inflammation after cataract surgery, as well for pain control after refractive surgery. Their use in recent years has increased significantly.
Despite the increased use of these drugs after ocular surgery, reports of corneal complications due to NSAID use have been uncommon. Complications reported have included superficial punctate keratitis, subepithelial infiltrates, stromal infiltrates, immune rings, persistent epithelial defects and, most recently, corneal melting. Reports of corneal melting following the use of topical diclofenac after cataract surgery have attracted a great deal of attention. A 1999 study by the American Society of Cataract and Refractive Surgery (ASCRS) reported that the majority of these problems were seen with generic diclofenac.
Retrospective study
It has been our clinical impression that Voltaren (diclofenac sodium 0.1%, Novartis Ophthalmics) has not been associated with any significant problems in our cataract surgery practice. We therefore performed a retrospective study in order to assess the safety and efficacy of diclofenac sodium 0.1% (Voltaren) for the prevention of postoperative inflammation in cataract surgery. We studied 1,052 consecutive eyes of 810 patients who underwent cataract surgery from January 1998 to April 2001. Inclusion criteria included all patients operated on during this time period who had a minimum of 3 months of follow-up. In the study, Voltaren was used three times daily, beginning 1 week postoperatively and continued for 3 additional weeks, in all patients.
We performed cataract surgery with implantation of a posterior chamber IOL in 1,052 eyes from January 1998 to April 2001. All surgery was performed by Dr. Epstein and used the following protocol.
Following administration of retrobulbar anesthesia and Nadbath akinesia consisting of injections of 1% lidocaine, a paracentesis incision was made with a 15° micro-razor knife 90° from the temporal incision site. Viscoelastic was injected to fill the anterior chamber. A calibrated diamond keratome knife (Huco, Model 41588, Clear Cornea Trapezoid Blade) was used to make a corneal tunnel incision 2.8 mm in width and 2 mm in length. A continuous curvilinear capsulorrhexis was completed.
After hydrodissection and hydrodelineation, phacoemulsification was performed using David Dillman’s “quick chop” technique. Residual cortex was removed with irrigation and aspiration. The capsular bag was inflated and the anterior chamber deepened with viscoelastic (Amvisc Plus, Bausch & Lomb Pharmaceuticals). The initial incision site was then enlarged. After IOL implantation within the capsular bag, residual viscoelastic material was removed with an irrigation-aspiration tip and the incision was closed with stromal hydration.
At the end of the procedure, the wound was checked using gentle external pressure to make certain that it was self-sealing. If wound leakage was noted, a single 10-0 nylon suture was placed to close the wound.
No bipolar cautery was used. All patients were treated with topical gentamicin sulfate ophthalmic solution four times daily for 1 week and prednisolone sodium phosphate 1% four times daily for 1 week. They were then switched to Voltaren three times a day for an additional 3 weeks. Any sutures that had been placed were removed at 1 week postop.
Patients were examined at 1 day, 1 week, 1 month, 4 months, 1 year and then annually after surgery. All visual acuities, refractions and corneal topography studies were performed by certified ophthalmic technicians. Careful slit-lamp examinations were performed by fellowship-trained corneal specialists at all postop visits.
Ten patients underwent limited anterior vitrectomies during the course of their procedures due to posterior capsular rupture. All of these patients were still able to undergo posterior chamber IOL implantation within the ciliary sulcus (two cases) or within the damaged posterior capsular bag (eight cases). Eleven patients developed clinically significant cystoid macular edema, which cleared within 3 months on topical Voltaren therapy in all cases.
No postop complications were specifically associated with the use of Voltaren postoperatively. Follow-up ranged from 3 months to 3 years after surgery. Three patients required drug discontinuation due to sensitivity reactions that occurred within 1 week of the onset of therapy. These reactions included redness and irritation and cleared promptly following drug cessation. None of these patients suffered additional sequelae.
Lin and colleagues reported a series of five cases of corneal melts that had occurred with generic diclofenac as well as Voltaren. This contrasts with the ASCRS study, which found that the majority of corneal melts occurred with generic diclofenac. In other reported cases, patients had co-morbid conditions, including severe keratoconjunctivitis sicca. In some reported cases, patients had also received NSAIDs in their intraocular irrigation infusion systems, which may have led to additive toxicity.
In our series of 1,052 eyes, no postop complications were associated with the use of Voltaren. All patients received brand-name Voltaren and care was taken to verify that no generic substitutions took place. In addition, the proper use of Voltaren was verified with each patient after surgery. The use of Voltaren three times daily was reinforced and as-needed use of this medication was not permitted.
It should be noted that we began Voltaren therapy 1 week postoperatively, when all of our patients’ incisions had had the chance to epithelialize completely. Promotion of corneal ulceration in this setting would be very unlikely. While the use of topical NSAIDS after cataract surgery should be approached with care, we believe the use of Voltaren, using the protocol we have described, is safe and effective.
For Your Information:Reference:
- Sanjay N. Rao, MD, can be reached at The Eye Centers of Racine and Kenosha, 3803 Spring St., Racine, WI 53405; (262) 637-0500; fax: (262) 637-7650. Dr. Rao has no financial interest in the products mentioned in this article. He received unrestricted grant support from CIBA Vision Ophthalmics/Novartis Ophthalmics.
- Randy J. Epstein, MD, can be reached at Chicago Cornea Consultants, 806 Central Ave., Suite 300, Highland Park, IL 60035; (847) 432-6010; fax: (847) 432-8241. Dr. Epstein has no financial interest in the products mentioned in this article, nor is he a paid consultant for any companies.
- Novartis Ophthalmics can be reached at 11695 Johns Creek Pkwy., Duluth, GA 30097; (800) 656-5660; fax: (770) 905-1883.
- Gills JP. Voltaren associated with medication keratitis [letter]. J Cataract Refract Surg. 1994;20:110.
- Sher NA, Krueger RR, et al. Role of topical corticosteroids and nonsteroidal anti-inflammatory drugs in the etiology of stromal infiltrates after excimer photorefractive keratectomy. J Refract Corneal Surg. 1994;10:587-588.
- Probst LE V, Machat JJ. Corneal subepithelial infiltrates following photorefractive keratectomy [letter]. J Cataract Refract Surg. 1996;22:281.
- Shimazaki J, Saito H, et al. Persistent epithelial defect following penetrating keratoplasty: an adverse effect of diclofenac drops. Cornea. 1995;14:623-627.