Anna Zaczek1, Ditte Artzen2, Carl-Gustaf Laurell2, Ulf Stenevi2, Per Montan2. 1. From Sahlgrenska University Hospital (Zaczek, Stenevi), Mölndal, and St. Erik Eye Hospital (Artzen, Laurell, Montan), Stockholm, Sweden. Electronic address: anna.zaczek@scanloc.se. 2. From Sahlgrenska University Hospital (Zaczek, Stenevi), Mölndal, and St. Erik Eye Hospital (Artzen, Laurell, Montan), Stockholm, Sweden.
Abstract
PURPOSE: To evaluate the efficacy of adding nepafenac 0.1% ophthalmic suspension to dexamethasone 0.1% eyedrops in controlling macular swelling and other manifestations of inflammationafter uneventful cataract surgery. SETTING: Ophthalmology Department, Mölndal Hospital, Gothenburg, and St. Erik Eye Hospital, Stockholm, Sweden. DESIGN: Randomized double-masked clinical trial. METHODS:Patients at low risk for postoperative inflammation were recruited and randomized to the nepafenac group or to the control group. Postoperative swelling of the macula was assessed with ocular coherence tomography. Laser flare intensity, corrected distance visual acuity, ocular discomfort, and visual complaints were also recorded. RESULTS: The analysis of intent-to-treat population comprised 75 patients in the nepafenacgroup and 77 patients in the control group. Compared with the control regimen, add-on nepafenac resulted in statistically significant reductions in the following parameters: change in macular volume at 3 weeks and 6 weeks (P<.001), proportion of patients with more than 10 μm of swelling in the central macula at 3 weeks (P<.0001) and 6 weeks (P=.02), mean laser flare intensity at 1 day (P=.029), pain during the first 24 hours postoperatively (P<.0001), and ocular discomfort and photophobia during the first 3 postoperative weeks (P=.0058 and P=.0052, respectively). CONCLUSION: The combination of topical nepafenac and steroid treatment reduced subclinical macular swelling and inflammation as well as subjective complaints, indicating it is an efficient antiinflammatory regimen after cataract surgery. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.
RCT Entities:
PURPOSE: To evaluate the efficacy of adding nepafenac 0.1% ophthalmic suspension to dexamethasone 0.1% eyedrops in controlling macular swelling and other manifestations of inflammation after uneventful cataract surgery. SETTING: Ophthalmology Department, Mölndal Hospital, Gothenburg, and St. Erik Eye Hospital, Stockholm, Sweden. DESIGN: Randomized double-masked clinical trial. METHODS:Patients at low risk for postoperative inflammation were recruited and randomized to the nepafenac group or to the control group. Postoperative swelling of the macula was assessed with ocular coherence tomography. Laser flare intensity, corrected distance visual acuity, ocular discomfort, and visual complaints were also recorded. RESULTS: The analysis of intent-to-treat population comprised 75 patients in the nepafenac group and 77 patients in the control group. Compared with the control regimen, add-on nepafenac resulted in statistically significant reductions in the following parameters: change in macular volume at 3 weeks and 6 weeks (P<.001), proportion of patients with more than 10 μm of swelling in the central macula at 3 weeks (P<.0001) and 6 weeks (P=.02), mean laser flare intensity at 1 day (P=.029), pain during the first 24 hours postoperatively (P<.0001), and ocular discomfort and photophobia during the first 3 postoperative weeks (P=.0058 and P=.0052, respectively). CONCLUSION: The combination of topical nepafenac and steroid treatment reduced subclinical macular swelling and inflammation as well as subjective complaints, indicating it is an efficient antiinflammatory regimen after cataract surgery. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.
Authors: Richard S Hoffman; Rosa Braga-Mele; Kendall Donaldson; Geoffrey Emerick; Bonnie Henderson; Malik Kahook; Nick Mamalis; Kevin M Miller; Tony Realini; Neal H Shorstein; Richard K Stiverson; Barbara Wirostko Journal: J Cataract Refract Surg Date: 2016-09 Impact factor: 3.351