Abstract
BackgroundDefine the effectiveness of a topical non-steroidal anti-inflammatory drug (NSAID) added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema (PCME) using a prospective, randomized, double-masked, placebo-controlled clinical study.MethodsEyes (1000) were randomized to placebo (497) or nepafenac 0.3% (503) used once daily, post-operatively for 5 weeks at two ophthalmology clinics. Diagnosis of PCME was made by clinical, ocular coherence tomography (OCT), and with fluorescein angiography confirmation. Correlation of PCME to NSAID use and the presence of pre-operative risk factors for PCME were assessed including, contralateral PCME, diabetic retinopathy, retinal vein occlusion, macular hole, epiretinal membrane, macular degeneration, retinal detachment repair, and prostaglandin use.ResultsPCME was the most common complication associated with routine cataract surgery (4.2% with PCME risk factors, 2.0% with risk factors excluded). Topical nepafenac 0.3% significantly reduces the incidence of PCME compared to placebo when used after routine cataract surgery (p = .0001). When patients with pre-operative risk factors are excluded, the incidence of PCME between treatment and placebo groups is equivalent (p = 0.31). PCME relative risk (RR) was most significant in contralateral PCME (RR 19.5), diabetic retinopathy (RR 13.1), retinal vein occlusion (RR 12.9), macular hole (RR 7.7), and epiretinal membrane (RR 5.7). Prostaglandin use and previous retinal detachment were not shown to increase risk.ConclusionPseudophakic cystoid macular edema is common after phacoemulsification cataract surgery. Topical nepafenac 0.3% reduces PCME in patients with pre-operative risk factors for PCME compared to placebo but shows no benefit in patients without pre-operative risk factors.Trial registrationNIH ClincalTrials.gov retrospectively registered January 15, 2017, NCT03025945.
Highlights
Define the effectiveness of a topical non-steroidal anti-inflammatory drug (NSAID) added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema (PCME) using a prospective, randomized, double-masked, placebo-controlled clinical study
Cataract surgery is one of the most commonly performed surgeries. This procedure is generally safe, the most common adverse event leading to postoperative vision loss is the development of pseudophakic cystoid macular edema (PCME) [1]
All cases of PCME resolved with treatment
Summary
Define the effectiveness of a topical non-steroidal anti-inflammatory drug (NSAID) added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema (PCME) using a prospective, randomized, double-masked, placebo-controlled clinical study. Cataract surgery is one of the most commonly performed surgeries. This procedure is generally safe, the most common adverse event leading to postoperative vision loss is the development of pseudophakic cystoid macular edema (PCME) [1]. The incidence of clinically significant acute PCME Significant PCME includes ophthalmic and angiographic findings with vision loss. A visual acuity of 20/40 best corrected visual acuity (BCVA) or less has been considered clinically significant by most studies [4, 5]. Findings of angiographic PCME do not correlate well with vision loss. Measurement of macular thickness with optical coherence tomography (OCT) does correlate well with visual impairment [6, 7]
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