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CHICAGO -- Topical nepafenac 0.3% as adjunctive therapy to topical prednisone can prevent pseudophakic cystoid macular edema (PCME) in cataract surgery recipients, but only in those with identified preoperative risk factors.

Limiting topical nonsteroidal anti-inflammatory drug (NSAID) use to such patients has the potential to realize savings without compromising PCME outcomes, said from Arizona Eye Consultants, Tucson, lead investigator of a placebo-controlled trial reported here at the 2016meeting.

PCME is the most common complication following cataract surgery, with a prevalence of 1% to 2.5%. It is described as self-limited "but almost always requires treatment with topical steroids and topical NSAIDs and/or sub-Tenon's injections," said McCafferty.

Although no topical NSAID is approved for prevention of PCME, most cataract surgeons report using topical NSAIDs off label primarily for this purpose, he said. In the prospective double-blind placebo-controlled trial 1,000 patients were randomized to placebo or nepafenac 0.3% once daily for 5 weeks. The study was investigator initiated with no industry support. Patients with uveitis within the prior 6 months were excluded.

All intraocular lenses implanted were single-piece hydrophobic acrylic lenses.

Clinical PCME was defined as loss of two or more lines of best corrected visual acuity and/or symptomatic or visual distortion, in addition to PCME as demonstrated with both macular optical coherence tomography and fluorescein angiography.

The incidence of PCME in all eyes was 4.20%, with an incidence of 2.17% in the 692 patients without risk factors and 8.77% in the 308 patients with risk factors.

In the overall cohort, there was a significant reduction in the occurrence of PCME in the arm randomized to topical nepafenac 0.3% (P=0.0001). When the results were stratified according to the presence or absence of risk factors, however, the reduction in the incidence of PCME with randomization to topical nepafenac 0.3% was not significant (P=0.31089) among the patients without risk factors but was highly significant (P=0.00003) in the patients with risk factors. The 5-week postoperative change in macular volume with topical NSAID use was also not significant in patients without risk factors.

In a general ophthalmology practice, patients with risk factors for PCME constitute 10% to 30% of patients, according to McCafferty.

PCME in the contralateral eye increased the relative risk of developing PCME in the fellow eye by 19.5 times. Other risk factors that increased the risk of PCME were diabetic retinopathy (RR 13.1), retinal vein occlusion (RR 12.6), macular hole (RR 7.7) and epiretinal membrane (RR 5.7). "Interestingly, prostaglandin use was not significant, as well as macular degeneration," he said.

Given the similarities between topical nepafanic 0.3% and other topical NSAIDs with respect to anterior chamber concentrations and other properties, "we feel that this data is also able to be extrapolated to NSAIDs in general," McCafferty said.

Other benefits to using topical NSAIDs in the post-cataract surgery patient include decreases in inflammation and pain. The effect on these endpoints, as well on posterior capsule opacification and endothelial cell counts are forthcoming.