Trial reportJournal of cataract and refractive surgery2026
Randomized comparative multicenter study assessing two dispersive viscosurgical devices for cataract surgery.
Trial report in Journal of cataract and refractive surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The trial behind it
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo compare 2 dispersive ophthalmic viscosurgical devices (OVDs), Z-HYALCOAT (investigational) and HEALON EndoCoat (control), with a 3-month postoperative follow-up.
settingMulticenter study conducted in 11 sites across Europe.
designProspective, randomized, masked, multicenter postmarket study.
methodsAdult 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.
results242 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.
conclusionsThis 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.
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