January 19, 2016
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AAO report: Limited high-level evidence for long-term benefit of NSAIDs after cataract surgery

The ASCRS disagrees with this finding and recommends different primary endpoints.

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There is insufficient high-quality evidence to support the long-term benefits of NSAID therapy to prevent vision loss from cystoid macular edema after cataract surgery, according to a report.

Cystoid macular edema (CME) is the most common cause of visual impairment and, if chronic, can result in considerable morbidity, lead author Stephen J. Kim, MD, told Ocular Surgery News.

“Although most cases of CME are mild and self-limiting, any disruption in the return of good vision following surgery is a cause for concern and stress to both the patient and surgeon,” Richard S. Hoffman, MD, chair of the Cataracts Clinical Committee for the American Society of Cataract and Refractive Surgery, said. “Patients who develop visually significant CME following surgery can become suspicious of their surgical procedure despite a totally uncomplicated surgery, leaving potential distrust of the surgeon while the vision is recovering.”

CME can also increase cataract surgery costs by approximately 50%, the report said.

To treat CME, corticosteroid treatments are used for anti-inflammatory effects, while NSAIDs may be used in conjunction with or, less commonly, as a substitute for corticosteroids.

In evaluating new and existing procedures, drugs and diagnostic/screening tests, the American Academy of Ophthalmology’s Ophthalmic Technology Assessment (OTA) Committee reviewed literature to gauge the effectiveness of prophylactic topical NSAIDs in preventing vision loss due to CME after cataract surgery.

Stephen J. Kim

Published results

Among the literary searches from PubMed and the Cochrane Library databases, the report authors reviewed the abstracts of 149 unique citations and selected 27 articles of possible clinical relevance for full-text review. Among those, 12 were deemed relevant for full review, while two additional articles from the reference lists of articles and one article from a national meeting were also selected for review.

“The articles were read, analyzed and interpreted individually, and then results were collectively summarized. This is very different from a meta-analysis,” Kim said.

The 15 studies were assigned a level of evidence based on a rating scale in which a level 1 rating was assigned to well-designed and well-conducted randomized clinical trials; a level 2 rating was assigned to well-designed case-control and cohort studies and poor-quality randomized studies; and a level 3 rating was assigned to case series, case reports, and poor-quality cohort and case-control studies.

The report, published in Ophthalmology, contained six level 1 articles, nine level 2 articles and no level 3 articles.

OTA conclusions

Evidence from the literature showed that NSAIDs are effective in reducing the incidence of CME as seen on angiography or OCT, while also speeding up visual recovery in the short term in comparison to placebo or topical corticosteroid formulations that have poor corneal penetration, the report said.

However, level 1 and 2 evidence did not suggest that the use of NSAIDs reduced long-term vision loss.

Additionally, the clinical impression that the use of corticosteroids and NSAIDs is synergistic was not proven in the literature.

“Although previous studies have suggested that NSAIDs may facilitate a greater re-establishment of the blood-aqueous barrier than corticosteroids, key differences in drug concentration and pharmacokinetics preclude any conclusions about synergy,” the report said.

ASCRS disagreement

The ASCRS strongly disagreed with the initial draft of the OTA report, arguing that “focusing solely on Snellen acuity at 3 months ignores any preventable delay in visual rehabilitation before that time that might be reduced by the routine use of NSAIDs,” according to an editorial in Ophthalmology.

Richard S. Hoffman

“I cannot speak for ASCRS in general. However, the main concern of this paper is that it ignores all of the potential benefits of NSAIDs for use before, during and following cataract surgery,” Hoffman said. “By stating that there are no differences in visual acuities following CME at 3 months, this paper sets the stage for third-party payers and CMS regulators who are not familiar with the nuances of CME development and treatment to deny the coverage for these medications coincident with cataract surgery.”

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The ASCRS recommended the primary endpoints to be visual acuity at 1 month postoperatively and patient-reported quality of life.

“The reality is, these medications have been shown to reduce the risk of developing CME in routine and especially high-risk eyes,” Hoffman said. “A reduction in the incidence of CME means there will be less surgical patients unhappy with their result during the 3-month postoperative period and less patients who run the risk of having a permanent alteration in the visual function if they do develop CME.”

Additionally, Hoffman said he feels NSAIDs have been shown to improve mydriasis during surgery, reduce intraoperative and postoperative pain, may reduce the severity of posterior capsule opacification, and reduce postoperative inflammation in concert with steroids. Additionally, NSAIDs can be used in place of steroids in individuals who may not be able to use topical steroids.

“The use of these medications should be at the discretion of the surgeon, and the paper published in Ophthalmology ignores the potential benefits of NSAIDs while coming to their conclusions ignoring many well-written papers that may differ with their assessment,” he said.

Treatment options

For CME prevention, Kim said he prefers to use prednisolone acetate 1% for 3 days before surgery and 1 week after surgery with a slow taper. For established CME, he treats with aggressive topical prednisolone acetate 1% for patients with less than 400 µm in thickness; for patients with more than 400 µm in thickness, he uses topical prednisolone in conjunction with either a sub-Tenon injection of 40 mg of triamcinolone or an intravitreal injection of 4 mg of triamcinolone.

Hoffman said he uses NSAIDs in conjunction with steroids if a patient develops CME.

“I will usually treat them with a potent topical NSAID and a potent steroid as long as they are not a steroid responder,” he said. “The topical NSAID has been shown to be more efficacious for treating CME than a steroid alone.”

Kim said he thinks that the biggest disadvantage of NSAIDs is cost. “Because nearly 3 million cataract surgeries are performed yearly in the U.S., routine use of NSAIDs therefore could correspond to an aggregate societal cost as high as $540 million annually if provided after every surgery,” according to the report.

Hoffman agreed that cost plays a major role in the use of NSAIDs as a prophylactic measure.

“Many surgeons do not use NSAIDs in routine eyes due to the added cost,” he said. “They reserve NSAIDs for high-risk eyes. In addition, cost forces many ophthalmologists to use less potent or less comfortable NSAIDs due to their availability as generics and insurances’ reluctance to cover the costs of newer NSAIDs.”

Future studies

In order to disprove the finding that corticosteroids and NSAIDs are not synergistic, Hoffman recommended a study comparing the incidence of CME in a group receiving three drops of NSAID therapy and three drops of steroids compared with a group receiving six drops of steroids to help demonstrate whether or not there is a synergistic effect.

Kim recommended balanced prospective studies to determine if NSAIDs add any value to corticosteroids in the prevention of CME and vision loss after routine cataract surgery.

Kim also stressed the importance of a standardized method of reporting CME, “which at the moment is highly variable and confounds assessment and direct comparison of results.”

“If there is no evidence that NSAIDs improve visual outcomes after cataract surgery, then this begs the question: How did use of NSAIDs for routine cataract surgery become so popularized among cataract surgeons?” he said. – by Kristie L. Kahl

Disclosures: Hoffman and Kim report no relevant financial disclosures.