Nancy A. Melville

May 06, 2014

BOSTON — Perioperative treatment with the nonsteroidal anti-inflammatory drug (NSAID) bromfenac was superior to combination therapy with an NSAID plus a steroid in preventing postoperative cystoid macular edema in patients undergoing cataract surgery, according to a 5-year analysis of more than 5000 surgeries.

Cystoid macular edema, a potentially serious vision-threatening complication of cataract surgery, occurs in about 1% to 3% of cataract surgery patients. NSAIDs are commonly used with topical steroids to control the inflammatory process believed to underlie the condition, but steroids are associated with adverse effects such as increased intraocular pressure.

"Bromfenac alone appears to be equal to or better than steroids as a drop regimen in preventing cystoid macular edema," said lead investigator Keith Walter, MD, associate professor of ophthalmology at Wake Forest University in Winston-Salem, North Carolina.

He presented results from the retrospective analysis here at the American Society of Cataract and Refractive Surgery 2014 Symposium.

The investigators evaluated cataract surgeries performed on 5380 eyes by 3 surgeons with similar training and more than 12 years of experience at Wake Forest Health Center from July 2007 to December 2012.

All eyes received the same implant (Infiniti, Alcon) and were treated with 1 of 4 regimens:

  • postoperative brand-name prednisolone acetate 1% (Pred Forte, Allergan) tapered over 5 weeks and, for patients with a history of cystoid macular edema, brand-name ketorolac (Toradol) 3 times daily

  • postoperative Pred Forte tapered over 5 weeks and, for high-risk patients, twice-daily brand-name bromfenac ophthalmic solution (Xibrom) for a month

  • generic prednisolone acetate 1% tapered and, for patients with a history of cystoid macular edema, generic ketorolac 0.4%

  • once-daily brand-name bromfenac ophthalmic solution (Bromday) from 2 days before surgery to 30 days after surgery.

Patients' eyes were evaluated with optical coherence tomography.

The rate of cystoid macular edema was significantly lower with bromfenac monotherapy than with the all-generic regimen (P = .0001), and than with Pred Forte plus Toradol (P = .005). It was also lower than with Pred Forte plus Xibrom, although not significantly.

Table. Rates of Cystoid Macular Edema With the 4 Treatment Regimens

Steroid NSAID Eyes Treated, n Cystoid Macular Edema, %
None bromfenac (Bromday) 1090 0.09
Prednisolone (Pred Forte) ketorolac (Toradol) 2437 0.90
Prednisolone (Pred Forte) bromfenac (Xibrom) 1128 0.44
Generic prednisolone generic ketorolac 725 2.20

 

Dr. Walter said the findings suggest that NSAIDs alone might be much more effective in preventing cystoid macular edema than would be expected.

"Most studies look mainly at steroids alone or steroids with NSAIDS; we don't ever look at just NSAIDS," he said. "This suggests that maybe it's the NSAID that is doing all of the activity in preventing cystoid macular edema."

Dr. Walter added that he has used bromfenac monotherapy as his standard of care for several years.

"The judicious use of bromfenac in every case — from 2 days before until 30 days after cataract surgery — totally eliminated cystoid macular edema. This was despite not having a steroid on board and it was despite risk factors, including pre-existing diabetes, intraoperative floppy iris syndrome, dense cataract, and history of epiretinal membrane," he told Medscape Medical News.

"I will occasionally use a steroid, but only about 1% of the time — if I see some inflammation. Most of time I don't use one," he explained. "My thought is that I can always add a steroid if I need it, but most patients do fine without it."

Although these findings are intriguing, more research is needed to confirm the results, said session comoderator Harvey Uy, MD, research chair in ophthalmology at St. Luke's Medical Center in Quezon City, the Philippines.

"Previous reports have demonstrated that bromfenac is as useful in preventing or treating postoperative cystoid macular edema as corticosteroids or other NSAIDs," he told Medscape Medical News.

"The surprise finding here is that bromfenac alone seemed superior to a combination with corticosteroids. This is a bit hard to explain — an analogy would be like saying using 1 bug spray killed more bugs than 2 bug sprays."

He explained that study limitations could account for some of the results.

"The main weakness of the study is its retrospective, uncontrolled design," said Dr. Uy. Some selection bias might also have influenced the outcome, he added.

"It is likely that at least some long, complex surgical cases were prescribed corticosteroids plus bromfenac or other corticosteroid plus NSAID combinations, whereas the smooth, fast surgeries were prescribed bromfenac alone."

"The best way to validate this would be to randomize eyes to receive a treatment regimen prior to surgery, using an intent-to-treat approach," he suggested.

Dr. Walter reports financial relationships with Bausch & Lomb, Abbott Medical Optics, and Ocular Systems. Dr. Uy has disclosed no relevant financial relationships.

American Society of Cataract and Refractive Surgery (ASCRS) 2014 Symposium. Presented April 25, 2014.

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