학술논문
Difluprednate 0.05% twice a day vs prednisolone acetate 1% 4 times a day for cataract postsurgical inflammation treatment: noninferiority trial.
Document Type
Academic Journal
Author
Valvecchia G; From the Centro de Ojos Quilmes, Quilmes, Buenos Aires, Argentina (Valvecchia, Masseroni); the Centro de Ojos Martínez, Martínez, Buenos Aires, Argentina (Kaufer, Idiart); the Clínica de ojos y cirugía refractiva Dr. Carlos Ferroni, Rosario, Santa Fe, Argentina (C. Ferroni, V. Ferroni); the Instituto Zaldívar, Mendoza, Argentina (Zaldívar, Marino); Universidad de Buenos Aires, Facultad de Farmacia y Bioquímica, Cátedra de Matemática, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (Nuñez); Laboratorios POEN S.A.U., Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (del Papa, Passerini).; Kaufer R; Ferroni C; Zaldívar R; Masseroni M; Idiart C; Ferroni V; Marino F; Nuñez M; Del Papa M; Passerini MS
Source
Publisher: Wolters Kluwer on behalf of ASCRS and ESCRS Country of Publication: United States NLM ID: 8604171 Publication Model: Print Cited Medium: Internet ISSN: 1873-4502 (Electronic) Linking ISSN: 08863350 NLM ISO Abbreviation: J Cataract Refract Surg Subsets: MEDLINE
Subject
Language
English
Abstract
Purpose: To establish whether difluprednate 0.05% nanoemulsion (DIFL) twice a day is as effective as prednisolone acetate 1% + phenylephrine hydrochloride 0.12% suspension (PRED) 4 times a day for postsurgical inflammation treatment.
Setting: 4 private Argentine ophthalmological centers.
Design: Noninferiority, prospective, multicenter, double-blind, randomized, parallel-group, comparative trial.
Methods: A total of 259 patients who underwent phacoemulsification randomly received DIFL or PRED, starting the day before surgery and continuing for 28 days. The primary endpoint was central corneal thickness. Noninferior anti-inflammatory efficacy was considered if the difference of corneal thickness between baseline and day 4 did not differ beyond 17 μm between treatments. Secondary endpoints were cell and flare, corrected distance visual acuity (CDVA), endothelial cell count, optical coherence tomography (OCT) central macular thickness, and intraocular pressure. All outcomes were evaluated at baseline and day 1, 4, and 28 postoperatively.
Results: 225 patients finished the study. The difference in corneal thickness at baseline and day 4 did not differ beyond 17 μm between treatments (95% CI -2.78 μm to 14.84 μm), with no statistically significant difference ( P = .523). No statistically significant differences were found between groups in total anterior chamber clearance at any study timepoint ( P > .05). Moreover, no statistically significant differences were reported between treatments in CDVA ( P = .455), endothelial cell count ( P = .811), OCT central macular thickness ( P = .869), and intraocular pressure outcome ( P = .316).
Conclusions: Difluprednate administered twice a day was at least as effective as prednisolone acetate administered 4 times a day for inflammatory treatment after cataract surgery.
(Copyright © 2021 Published by Wolters Kluwer on behalf of ASCRS and ESCRS.)
Setting: 4 private Argentine ophthalmological centers.
Design: Noninferiority, prospective, multicenter, double-blind, randomized, parallel-group, comparative trial.
Methods: A total of 259 patients who underwent phacoemulsification randomly received DIFL or PRED, starting the day before surgery and continuing for 28 days. The primary endpoint was central corneal thickness. Noninferior anti-inflammatory efficacy was considered if the difference of corneal thickness between baseline and day 4 did not differ beyond 17 μm between treatments. Secondary endpoints were cell and flare, corrected distance visual acuity (CDVA), endothelial cell count, optical coherence tomography (OCT) central macular thickness, and intraocular pressure. All outcomes were evaluated at baseline and day 1, 4, and 28 postoperatively.
Results: 225 patients finished the study. The difference in corneal thickness at baseline and day 4 did not differ beyond 17 μm between treatments (95% CI -2.78 μm to 14.84 μm), with no statistically significant difference ( P = .523). No statistically significant differences were found between groups in total anterior chamber clearance at any study timepoint ( P > .05). Moreover, no statistically significant differences were reported between treatments in CDVA ( P = .455), endothelial cell count ( P = .811), OCT central macular thickness ( P = .869), and intraocular pressure outcome ( P = .316).
Conclusions: Difluprednate administered twice a day was at least as effective as prednisolone acetate administered 4 times a day for inflammatory treatment after cataract surgery.
(Copyright © 2021 Published by Wolters Kluwer on behalf of ASCRS and ESCRS.)