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

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.