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  • https://doi.org/10.1097/j.jcrs.0000000000001837Copy DOI Icon

Randomized comparative multicenter study assessing two dispersive viscosurgical devices for cataract surgery

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Abstract

To compare two dispersive ophthalmic viscosurgical devices (OVD), Z-HYALCOAT (investigational) and HEALON EndoCoat (control), with a 3-month postoperative follow-up. Multicenter study conducted in 11 sites across Europe. Prospective, randomized, masked, multicenter post market study. Adult subjects having clear intraocular media excluding the presence of cataract and scheduled for uncomplicated age-related cataract removal by phacoemulsification and IOL 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 IOP ≥ 30 mmHg. Other endpoints included slit lamp observations, corneal endothelial cell density (ECD), surgeon-reported device functionality, and rate of adverse events (AEs) and device deficiencies (DDs). In total, 242 subjects 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 mmHg at 8 hours following device use. Slit lamp 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. This investigation proved the non-inferiority of Z-HYALCOAT to HEALON EndoCoat in terms of IOP spikes and showed the two devices to be highly similar in all evaluated aspects.

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