Journal of cataract and refractive surgery · 2021
Safety and efficacy of nepafenac punctal plug delivery system in controlling postoperative ocular pain and inflammation after cataract surgery.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Donnenfeld Eric D, Holland Edward J, Solomon Kerry D
Аннотация
PURPOSE: To evaluate the safety and efficacy of a nepafenac punctal plug delivery system (N-PPDS) after cataract surgery.
SETTING: Three U.S. clinical sites.
DESIGN: Prospective, multicenter, randomized (2:1), parallel-arm, double-masked, placebo-controlled, phase II pilot study.
METHODS: Fifty-six subjects (aged older than 22 years) with expected postcataract correctable distance vision of 20/30 or better and lower puncta allowing dilation up to 1.0 mm received either the nepafenac (N-PPDS group; n = 38 eyes) or a placebo punctal plug delivery system (p-PPDS group; n = 18 eyes). All eyes underwent routine unilateral cataract surgery with intraocular lens implantation. The primary and secondary efficacy measures were postoperative ocular pain and inflammation, respectively.
RESULTS: There were 38 patients in the experimental N-PPDS group and 18 patients in the control group. The N-PPDS group had a significantly higher percentage of pain-free patients than that in the p-PPDS group (22/32 [69%] vs 6/16 [38%] at 3 days, P = .038; and 24/36 [67%] vs 5/16 [31%] at 7 days, P = .018). A higher percentage of patients in the N-PPDS group (15/29 [52%] vs 0/14 [0%] in p-PPDS) was pain free at all visits (P = .001). Anterior chamber cell scores were better in the N-PPDS group (patients with no anterior chamber cells: 18/36 [50%] vs 3/16 [19%] in p-PPDS; P = .034) at 7 days. The plug retention rate was 98% (55/56) at 14 days. Adverse events having a suspected relationship with the punctal plug treatment occurred in 1 case of the N-PPDS group having to do with placement and zero in the p-PPDS group.
CONCLUSIONS: The N-PPDS was safe and effective for the management of ocular pain and inflammation after cataract surgery.
SETTING: Three U.S. clinical sites.
DESIGN: Prospective, multicenter, randomized (2:1), parallel-arm, double-masked, placebo-controlled, phase II pilot study.
METHODS: Fifty-six subjects (aged older than 22 years) with expected postcataract correctable distance vision of 20/30 or better and lower puncta allowing dilation up to 1.0 mm received either the nepafenac (N-PPDS group; n = 38 eyes) or a placebo punctal plug delivery system (p-PPDS group; n = 18 eyes). All eyes underwent routine unilateral cataract surgery with intraocular lens implantation. The primary and secondary efficacy measures were postoperative ocular pain and inflammation, respectively.
RESULTS: There were 38 patients in the experimental N-PPDS group and 18 patients in the control group. The N-PPDS group had a significantly higher percentage of pain-free patients than that in the p-PPDS group (22/32 [69%] vs 6/16 [38%] at 3 days, P = .038; and 24/36 [67%] vs 5/16 [31%] at 7 days, P = .018). A higher percentage of patients in the N-PPDS group (15/29 [52%] vs 0/14 [0%] in p-PPDS) was pain free at all visits (P = .001). Anterior chamber cell scores were better in the N-PPDS group (patients with no anterior chamber cells: 18/36 [50%] vs 3/16 [19%] in p-PPDS; P = .034) at 7 days. The plug retention rate was 98% (55/56) at 14 days. Adverse events having a suspected relationship with the punctal plug treatment occurred in 1 case of the N-PPDS group having to do with placement and zero in the p-PPDS group.
CONCLUSIONS: The N-PPDS was safe and effective for the management of ocular pain and inflammation after cataract surgery.