Journal of cataract and refractive surgery · 2026
Real-world characteristics and safety outcomes of 10 000 eyes treated with intracanalicular dexamethasone insert: IRIS registry analysis 2019 to 2021.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Vantipalli Srilatha, Mbagwu Michael, Chang Robert T, Li Sonya, Akasheh Dina, Cheung Matthew W, Gurses-Ozden Rabia, Goldstein Michael H
Аннотация
PURPOSE: To characterize real-world patient profiles and safety-related diagnoses from the first 10 000 eyes receiving the dexamethasone intracanalicular (DEX) insert indicated for the treatment of ocular inflammation and pain after ophthalmic surgery.
SETTING: American Academy of Ophthalmology Intelligent Research in Sight Registry.
DESIGN: Retrospective cohort study of electronic health records.
METHODS: All eyes that received DEX 2 days before or up to 7 days after cataract surgery (DEX+ group) between June 1, 2019 (start of commercialization), and March 31, 2021, were identified by procedure coding. A control cohort of eyes not receiving DEX (DEX- group) was drawn from the same practices as DEX+ eyes. Outcomes included characterization of demographics, comorbidities, and safety events of interest.
RESULTS: 10 313 DEX+ and 425 098 DEX- eyes were analyzed of 3 703 177 eyes undergoing cataract procedures during the index period. Eyes with a history of coded conditions relating to ocular surface disease (OSD) received DEX at a higher rate than eyes without a history of OSD (n = 3311 [32.1%] vs n = 104 205 [24.5%], P < .0001), and approximately one-quarter of eyes in both cohorts had preexisting glaucoma (n = 2634 and n = 105 700 eyes, respectively). Postoperative inflammatory events, corneal edema, and lacrimal disorders were uncommon (<2%) and had a comparable incidence in both cohorts. In DEX+ and DEX- eyes, the incidence of cystoid macular edema (n = 130, 1.3% and n = 2673, 0.6%, respectively, P < .0001) and epiphora (n = 73, 0.7% and n = 899, 0.2%, respectively, P < .0001) was low. DEX+ and DEX- cohorts had comparable incidence of intraocular pressure (IOP) elevations ≥10 mm Hg and similar mean IOP changes through postoperative month 1.
CONCLUSIONS: The DEX insert was found to have comparable inflammation, lacrimal disorder, and IOP outcomes with alternate perioperative therapy after cataract surgery, and real-world safety outcomes in this cohort of more than 10 000 eyes were similar to those observed in prior DEX clinical trials. The DEX intracanalicular insert may be considered as a suitable alternative treatment option to topical anti-inflammatory drops in patients undergoing cataract surgery.
SETTING: American Academy of Ophthalmology Intelligent Research in Sight Registry.
DESIGN: Retrospective cohort study of electronic health records.
METHODS: All eyes that received DEX 2 days before or up to 7 days after cataract surgery (DEX+ group) between June 1, 2019 (start of commercialization), and March 31, 2021, were identified by procedure coding. A control cohort of eyes not receiving DEX (DEX- group) was drawn from the same practices as DEX+ eyes. Outcomes included characterization of demographics, comorbidities, and safety events of interest.
RESULTS: 10 313 DEX+ and 425 098 DEX- eyes were analyzed of 3 703 177 eyes undergoing cataract procedures during the index period. Eyes with a history of coded conditions relating to ocular surface disease (OSD) received DEX at a higher rate than eyes without a history of OSD (n = 3311 [32.1%] vs n = 104 205 [24.5%], P < .0001), and approximately one-quarter of eyes in both cohorts had preexisting glaucoma (n = 2634 and n = 105 700 eyes, respectively). Postoperative inflammatory events, corneal edema, and lacrimal disorders were uncommon (<2%) and had a comparable incidence in both cohorts. In DEX+ and DEX- eyes, the incidence of cystoid macular edema (n = 130, 1.3% and n = 2673, 0.6%, respectively, P < .0001) and epiphora (n = 73, 0.7% and n = 899, 0.2%, respectively, P < .0001) was low. DEX+ and DEX- cohorts had comparable incidence of intraocular pressure (IOP) elevations ≥10 mm Hg and similar mean IOP changes through postoperative month 1.
CONCLUSIONS: The DEX insert was found to have comparable inflammation, lacrimal disorder, and IOP outcomes with alternate perioperative therapy after cataract surgery, and real-world safety outcomes in this cohort of more than 10 000 eyes were similar to those observed in prior DEX clinical trials. The DEX intracanalicular insert may be considered as a suitable alternative treatment option to topical anti-inflammatory drops in patients undergoing cataract surgery.