NSAID plus steroid better than steroid alone

"This study indicates that ketorolac tromethamine 0.4% should be used pre- and postoperatively in every patient undergoing cataract surgery because we want to reduce the patient's risk of any macular thickening at all. It eliminates the risk of CME, even in low-risk patients," said John R. Wittpenn Jr., MD, Ophthalmic Consultants of Long Island, Stony Brook, NY.

This new study is more evidence that nonsteroidal anti-inflammatory drugs (NSAIDs) are beneficial in cataract surgery. Previous studies have shown that patients receiving diclofenac sodium ophthalmic solution 0.1% (Voltaren, Novartis) after cataract surgery had less CME-as measured by optical coherence tomography [OCT]-than patients receiving steroids only, demonstrating that NSAIDs are beneficial in uneventful cataract surgery, he said. NSAIDs selectively block formation of prostaglandins following surgical trauma and are active against macular leakage initiated by a prostaglandin cascade triggered by surgery.

Many have argued, however, that this two-pronged approach should be reserved for patients at high risk of CME, such as those with diabetic macular edema, vascular disease, or other macular problems, he continued.

To learn more about NSAIDs and steroids in patients undergoing cataract surgery, Dr. Wittpenn and colleagues designed a randomized, investigator-masked, multicenter study to compare ketorolac plus steroid with steroid alone.

The key inclusion criteria were individuals who were aged 18 years or more scheduled to undergo cataract surgery with surgeon expectations of 20/20 best-corrected visual acuity postoperatively. Patients with risk factors for CME, such as a history of macular or vascular problems, iritis, or uveitis, were excluded, because the objective was to have uneventful surgery, Dr. Wittpenn explained. If difficulties or complications such as vitreous loss arose, the surgeon could discontinue patients from the study during surgery or postoperatively.

Do NSAIDs make difference?

"The patients who come through this study should be what I like to call the best of the best," he said. "They should have no macular problems, 20/20 vision, and a straightforward postoperative course. We wanted to see if, in that situation, in the lowest-risk or supposed no-risk patients, the NSAIDs would make a difference. If they made a difference in this group of patients, then I would expect them to make a clear difference in the patients who are at a higher risk of CME."

In this study, 546 patients scheduled to undergo cataract surgery were randomly assigned to one of two groups in a 1:1 ratio. Group 1 received ketorolac q.i.d. for 3 days before surgery and four doses during dilation immediately before the procedure. These patients continued to use ketorolac q.i.d. postoperatively until they exited the study, and they also instilled prednisolone acetate ophthalmic suspension 1% (Pred Forte, Allergan) q.i.d. from a 5-ml bottle until it was empty.

Group 2 received an artificial tear solution for 3 days before surgery and ketorolac only during dilation. After surgery, these patients continued to use artificial tears until the 5-ml bottle was empty and instilled prednisolone q.i.d. from two 5-ml bottles until leaving the study.

Both groups received gatifloxacin ophthalmic solution 0.3% (Zymar, Allergan) q.i.d. for 3 days prior to surgery and every 15 minutes in the hour before surgery. They continued to use the antibiotic four times daily after surgery until the surgeon determined that the risk of infection had passed.