title: Pseudophakic cystoid macular edema prevention and risk factors; prospective study with adjunctive once daily topical nepafenac 0.3% versus placebo.
abstract: BACKGROUND
  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.
  
  
  METHODS
  Eyes (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.
  
  
  RESULTS
  PCME 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.
  
  
  CONCLUSIONS
  Pseudophakic 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.
  
  
  BACKGROUND
  NIH ClincalTrials.gov retrospectively registered January 15, 2017, NCT03025945 .
authors.affiliation: Arizona Eye Consultants, 355 N. Silverbell Ave, Tucson, AZ, 85745, USA. sjmccafferty66@hotmail.com.|University of Arizona, 6422 E. Speedway Ave, Tucson, AZ, 85710, USA. sjmccafferty66@hotmail.com.
authors.forename: Sean
authors.initials: S
authors.lastname: McCafferty
authors.affiliation: Retina Associates of Tucson, 6561 E. Carondelet Dr, Tucson, AZ, 85710, USA.|University of Arizona, 6422 E. Speedway Ave, Tucson, AZ, 85710, USA.
authors.forename: April
authors.initials: A
authors.lastname: Harris
authors.affiliation: Arizona Eye Consultants, 355 N. Silverbell Ave, Tucson, AZ, 85745, USA.
authors.forename: Corin
authors.initials: C
authors.lastname: Kew
authors.affiliation: Arizona Eye Consultants, 355 N. Silverbell Ave, Tucson, AZ, 85745, USA.
authors.forename: Tala
authors.initials: T
authors.lastname: Kassm
authors.affiliation: Arizona Eye Consultants, 355 N. Silverbell Ave, Tucson, AZ, 85745, USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Lane
authors.affiliation: Arizona Eye Consultants, 355 N. Silverbell Ave, Tucson, AZ, 85745, USA.|University of Arizona, 6422 E. Speedway Ave, Tucson, AZ, 85710, USA.
authors.forename: Jason
authors.initials: J
authors.lastname: Levine
authors.affiliation: Arizona Eye Consultants, 355 N. Silverbell Ave, Tucson, AZ, 85745, USA.
authors.forename: Meisha
authors.initials: M
authors.lastname: Raven
mesh_terms: D000287:Administration, Topical; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D044482:Benzeneacetamides / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D006801:Humans; D008269:Macular Edema / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D018918:Phacoemulsification; D010648:Phenylacetates / Q000008:administration & dosage*; D011446:Prospective Studies; D019591:Pseudophakia / Q000150:complications*; D012307:Risk Factors; D041623:Tomography, Optical Coherence; D014792:Visual Acuity
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D044482:Benzeneacetamides; D010648:Phenylacetates; C414203:nepafenac