Journal of cataract and refractive surgery · 2026
Randomized comparative multicenter study assessing two dispersive viscosurgical devices for cataract surgery.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Fabian Ekkehard, Janeková Andrea, de Arriba Palomero Pablo, Tañá-Rivero Pedro, Böhringer Daniel, Kretz Florian T A, Pašta Jiří, Touriño-Peralba Rosario
Аннотация
PURPOSE: To compare 2 dispersive ophthalmic viscosurgical devices (OVDs), Z-HYALCOAT (investigational) and HEALON EndoCoat (control), with a 3-month postoperative follow-up.
SETTING: Multicenter study conducted in 11 sites across Europe.
DESIGN: Prospective, randomized, masked, multicenter postmarket study.
METHODS: Adult participants having clear intraocular media excluding the presence of cataract and scheduled for uneventful age-related cataract removal by phacoemulsification and intraocular lens implantation in the capsular bag with sole administration of either investigational or control device as per randomization scheme were included in this study. Primary endpoint was the incidence of intraocular pressure (IOP) ≥30 mm Hg. Other endpoints included slitlamp observations, corneal endothelial cell density (ECD), surgeon-reported device functionality, and rate of adverse events and device deficiencies.
RESULTS: 242 participants were treated in this study (123 with the investigational OVD and 119 with the control OVD). In per-protocol population, 13 eyes (11.2%) from the investigational group and 19 (17.0%) from the control group reached an IOP equal to or higher than 30 mm Hg at 8 hours after device use. Slitlamp examinations performed up to 3 months did not reveal any relevant differences between the groups. ECD loss was also similar between the groups. Surgeon-reported OVD functionality was generally favorable and comparable for both devices.
CONCLUSIONS: This investigation proved the noninferiority of Z-HYALCOAT to HEALON EndoCoat in IOP spikes and showed the 2 devices to be highly similar in all evaluated aspects.
SETTING: Multicenter study conducted in 11 sites across Europe.
DESIGN: Prospective, randomized, masked, multicenter postmarket study.
METHODS: Adult participants having clear intraocular media excluding the presence of cataract and scheduled for uneventful age-related cataract removal by phacoemulsification and intraocular lens implantation in the capsular bag with sole administration of either investigational or control device as per randomization scheme were included in this study. Primary endpoint was the incidence of intraocular pressure (IOP) ≥30 mm Hg. Other endpoints included slitlamp observations, corneal endothelial cell density (ECD), surgeon-reported device functionality, and rate of adverse events and device deficiencies.
RESULTS: 242 participants were treated in this study (123 with the investigational OVD and 119 with the control OVD). In per-protocol population, 13 eyes (11.2%) from the investigational group and 19 (17.0%) from the control group reached an IOP equal to or higher than 30 mm Hg at 8 hours after device use. Slitlamp examinations performed up to 3 months did not reveal any relevant differences between the groups. ECD loss was also similar between the groups. Surgeon-reported OVD functionality was generally favorable and comparable for both devices.
CONCLUSIONS: This investigation proved the noninferiority of Z-HYALCOAT to HEALON EndoCoat in IOP spikes and showed the 2 devices to be highly similar in all evaluated aspects.