—Adding a topical nonsteroidal anti-inflammatory drug (NSAID) to treatment with a topical corticosteroid significantly reduces the incidence of clinical pseudophakic cystoid macular edema (PCME) in at-risk eyes.
Adjunctive topical NSAID use, however, has no effect on the development of clinical PCME in eyes without recognized risk factors, according to the results of a large, prospective, randomized, placebo-controlled trial presented at AAO 2016.
The study, which was independently funded and had no industry support, included 1,000 eyes that were treated with topical prednisolone and randomly assigned 1:1 to treatment with either nepafenac 0.3% (Ilevro, Alcon Laboratories) or placebo once daily.
Clinical PCME—defined as loss of two or more lines of BCVA and/or visually symptomatic distortion plus imaging evidence (OCT and fluorescein angiography) of CME—developed in 42 eyes overall (4.2%), and the incidence was significantly lower comparing the NSAID-treated eyes and the control group (p
= 0.0001), said Sean J. McCafferty, MD.
When eyes were stratified based on PCME risk factors, the incidence of PCME was 8.77% among the 308 at-risk eyes in the study and 2.17% in the nearly 700 eyes without any PCME risk factors, said Dr. McCafferty, a general ophthalmologist who practices in Tucson, AZ.
A statistically significant benefit of topical nepafenac for reducing the incidence of PCME was observed only in the at-risk group (p
Changes in macular volume were also analyzed, and the data bolstered the main findings, showing that use of the topical NSIAD reduced macular thickness volume increases only in the at-risk group.
“Patients with risk factors for PCME account for between 10% and 30% of cataract surgery patients seen in a general ophthalmology practice,” Dr. McCafferty said. “In the remaining 70% to 90%, it is unlikely that clinical PCME outcomes are improved with topical NSAID use.”
Data collected in the study were also analyzed to determine the relative risk of PCME associated with different clinical features. The results showed the highest risk for PCME was in eyes with a history of PCME in the contralateral eye.
Diabetic retinopathy, vein occlusion, macular hole, and epiretinal membrane were also associated with increased risk, whereas prostaglandin use and macular degeneration were not.
Providing clarity and guidance
Providing clarity and guidance
Dr. McCafferty and colleagues were motivated to undertake the investigation recognizing that PCME is the most common complication after cataract surgery and topical NSAIDs are widely used to prevent its occurrence despite a paucity of evidence to show these anti-inflammatory medications are or are not effective.
“According to various studies, the incidence of PCME ranges from 1.0% to 1.25%, and although PCME is described as self-limiting, it can lead to disappointed patients, causes concern among surgeons, and often requires additional treatment,” Dr. McCafferty said.
No topical NSAID has an FDA-approved indication for preventing clinical PCME.
Nevertheless, a survey conducted by Dr. McCafferty and colleagues found that 72% of the participating cataract surgeons said they use a topical NSAID in their patients primarily to prevent PCME.
A review of the available evidence on NSAID prevention of PCME reveals a 20-year history of data alluding to improved outcomes.
However, there are also some double-blind placebo controlled trials that did not show a benefit.
“The latter studies may have excluded patients with risk factors for PCME and may have not been adequately sized to show a statistically significant effect,” Dr. McCafferty said.
“A topical NSAID can cost patients up to $200 per bottle,”he said. “In order to try to decide how best to use these products, we designed our own prospective study and included patients with recognized risk factors so that the information would be useful for helping general ophthalmologists make decisions in their routine practice.”
Dr. McCafferty suggested that the findings of this study can be generalized to the use of other topical NSAIDs considering similar mode of action.
He also noted NSAIDs provide other benefits for use in cataract surgery, including decreased inflammation and pain. Data on those parameters was also collected in the study and is being analyzed in addition to posterior capsule opacification rates and endothelial cell loss among other endpoints.
Dr. McCafferty has no relevant financial interests to disclose.